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Unsedated small-caliber esophagogastroduodenoscopy (EGD) versus conventional EGD: A comparative study
GASTROENTEROLOGY 1999;117:1301–1307
Unsedated Small-Caliber Esophagogastroduodenoscopy (EGD) Versus Conventional EGD: A Comparative Study DARIUS SORBI, CHRISTOPHER J. GOSTOUT, JESSICA HENRY, and KEITH D. LINDOR Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota
See editorial on page 1492. Background & Aims: Significant portions of the cost and complications of esophagogastroduodenoscopy (EGD) are related to sedation. This study aimed to assess the feasibility, acceptability, and accuracy of unsedated small-caliber transoral EGD (sc-EGD). Methods: A 4-phase study was performed in healthy volunteers and patients. Phases 1 and 2 involved assessment of the technical feasibility of sedated sc-EGD and the tolerability of unsedated sc-EGD, respectively, in volunteers. Subsequently, the technical feasibility, tolerability, and diagnostic accuracy of sedated and unsedated sc-EGD were determined by having each patient undergo sc-EGD (Pentax EG-1840) with (phase 3) and without (phase 4) sedation, followed by sedated conventional EGD (c-EGD) (Olympus GIF-100 or GIF-Q140) by a staff endoscopist blinded to the findings of the sc-EGD. The t test for paired samples was used for statistical analysis. A P value of F0.05 was considered significant. Results: Sedated and unsedated sc-EGD were technically feasible and tolerable in all volunteers. In patients, compared with sedated c-EGD, sedated and unsedated sc-EGD were 96% and 97% accurate, respectively. The overall acceptability of unsedated sc-EGD was only slightly worse than that of sedated c-EGD (median, 2 vs. 1 on a scale of 1–10). After unsedated sc-EGD, 98% of patients expressed willingness to undergo the procedure again. No complications were observed during any phase of the study. Conclusions: Unsedated sc-EGD is technically feasible, tolerable, and accurate. It can potentially decrease the costs and complications of sedated conventional EGD.
sophagogastroduodenoscopy (EGD) is a safe procedure.1 Although studies have suggested that endoscopy with sedation is more comfortable than without sedation,2–4 a significant portion of complications may be related to sedation. Elderly patients and individuals with underlying cardiopulmonary disease are at a greater risk.5–9 Furthermore, the use of sedation requires physiological monitoring and, at some centers, anesthesia
E
participation.5 Sedation also results in increased loss of work on the day of endoscopy7 and the need for a person to accompany the patient home after the procedure. The feasibility, tolerability, and diagnostic accuracy of unsedated EGD in normal volunteers as well as in patients with upper gastrointestinal symptoms have been studied.7,8,10–20 Unsedated endoscopy is the general practice in Asia and Latin America, as well as in some European countries.12,14,16,18–20 Although the sensitivity of transnasal, or transoral, unsedated EGD may be lower, the specificity seems to be comparable with sedated conventional EGD (c-EGD). Unsedated EGD also seems to be tolerable and potentially safer and more costeffective. The primary aim of this investigation was to assess the technical feasibility, tolerability, and diagnostic accuracy of small-caliber EGD (sc-EGD) compared with conventional upper endoscopy in healthy volunteers and patients.
Materials and Methods Esophagogastroduodenoscopes Small-caliber endoscopy was performed by using a Pentax small-caliber esophagogastroduodenoscope (Pentax EG1840; Pentax Precision Instrument Co., Orangeburg, NY) (Figure 1) and conventional endoscopy by the standard Olympus esophagogastroduodenoscope (GIF-100 or GIF-Q140; Olympus Corp., Tokyo, Japan). The Pentax small-caliber endoscope has a 6-mm insertion tube outer diameter and a 2-mm biopsy channel. The Olympus GIF-100 has a 9.5-mm insertion tube outer diameter and a 2.8-mm biopsy channel. The Olympus GIF-Q140 has a 10.5-mm insertion tube outer diameter and a 2.8-mm biopsy channel. All are end-viewing videoendoscopes with a field of view of 120°. The tip flexion capability was 180° up/down, and 160° right/left for all instruments. The optical quality of the small-caliber endoscope is good (Figure 2). Abbreviations used in this paper: c-EGD, conventional EGD; EGD, esophagogastroduodenoscopy; sc-EGD, small-caliber EGD. r 1999 by the American Gastroenterological Association 0016-5085/99/$10.00
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Figure 2. Image quality. Endoscopic image of an esophageal stricture as viewed by the (A) small-caliber and (B) conventional esophagogastroduodenoscopes.
Study Design
Figure 1. Small-caliber upper endoscope. (A) The distal tips of the small-caliber and the conventional esophagogastroduodenoscopes are shown for comparison, along with (B) the handle of the smallcaliber endoscope.
This multiphase prospective study was approved by the Institutional Review Board of the Mayo Clinic and Foundation. Phases 1 and 2 involved evaluation of the technical feasibility of sedated sc-EGD and the tolerability of unsedated sc-EGD in healthy volunteers, respectively. The technical feasibility and diagnostic accuracy of sedated sc-EGD compared with sedated c-EGD, and the tolerability and diagnostic accuracy of unsedated sc-EGD compared with sedated c-EGD, were assessed in phases 3 and 4, respectively. The staff investigators were experienced in performing both sedated conventional and unsedated small-caliber upper endoscopy.
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Phase 1: determining the feasibility of sedated scEGD.
Twenty healthy volunteers (age, 18–70 years) were studied to determine the feasibility of sedated sc-EGD for diagnostic purposes. All procedures were performed by 1 of the 2 staff investigators using the Pentax small-caliber endoscope. All subjects had their pharynx sprayed with 20% benzocaine. For intravenous sedation, midazolam was used as a slow injection in a sufficient dose to cause drowsiness or slurred speech. The procedure was defined as technically feasible if the endoscope could be passed into the second portion of the duodenum $90% of the time. Phase 2: determining the tolerability of unsedated sc-EGD. After establishing the technical feasibility of sedated
sc-EGD, 20 other volunteers (age, 18–70 years) were studied to determine the tolerability and feasibility of unsedated sc-EGD. Subjects underwent sc-EGD by 1 of the 2 experienced staff investigators. Only topical 20% benzocaine spray was used to anesthetize the pharynx. After the procedure, subjects were asked to comment on willingness to undergo the procedure again if medically indicated. Choking sensation, sore throat, discomfort, and overall acceptability were assessed on a scale of 1–10 (1, most acceptable/least severe; 10, least acceptable/most severe). Unsedated sc-EGD was defined as technically feasible and tolerable if the second portion of the duodenum was reached in $90% of the cases and $90% of the subjects were willing to have the procedure again if medically indicated. Phase 3: determining the diagnostic accuracy of sedated sc-EGD. Fifty patients (age, 18–70 years) referred to
our Gastrointestinal Diagnostic Unit for evaluation of upper gastrointestinal symptoms agreed to participate in the third phase of the study. The endoscopic indications considered for this study were (1) abnormal esophagus or gastroduodenal radiograph, (2) Barrett’s recheck, (3) familial polyposis, (4) gastric polyp recheck, (5) gastric ulcer follow-up, (6) hematemesis and/or melena, not active, (7) iron deficiency anemia, (8) persistent dyspepsia or pain despite therapy, (9) persistent esophageal pain despite therapy, (10) persistent vomiting, (11) positive fecal blood test result, (12) suspected Barrett’s esophagus, (13) suspected portal hypertension/varices, and (14) unexplained weight loss associated with gastrointestinal symptoms. The patients with the following indications were excluded: (1) dysphagia, (2) hematemesis, active, and (3) varices, requiring possible endoscopic therapy. The patients agreeing to participate in the study underwent sedated sc-EGD followed by c-EGD. One of the staff investigators performed sc-EGD, and another staff endoscopist blinded to the findings of the first endoscopy performed the second procedure. Details of age, sex, medical history, prior history of upper endoscopy, and the indication for EGD were recorded. All patients had their pharynx sprayed with 20% benzocaine. Intravenous midazolam was given for sedation. The standard Olympus esophagogastroduodenoscope was used for c-EGD. The findings of sc-EGD were compared with the findings of c-EGD to determine the diagnostic accuracy in detecting significant upper gastrointestinal lesions. Significant lesions
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were defined as large diaphragmatic hernias ($5 cm), stricture requiring dilatation, mass lesions, ulcers $5 mm, Barrett’s esophagus $3 cm, moderate to severe esophagitis, and esophageal or gastric varices. Sedated sc-EGD was considered accurate if its clinically significant findings agreed with those of c-EGD in $95% of cases. No biopsies were performed in the sc-EGD group. Phase 4: determining the diagnostic accuracy and tolerability of unsedated sc-EGD. Forty patients (age, 18–70
years) referred to our Gastrointestinal Diagnostic Unit for evaluation of upper gastrointestinal symptoms underwent unsedated sc-EGD performed by 1 of the 2 staff investigators followed by sedated c-EGD by another staff endoscopist. The exclusion and inclusion criteria are as listed under Phase 3. Details of age, sex, medical history, prior history of endoscopy, and the indication for EGD were recorded. All patients had their pharynx sprayed with 20% benzocaine. Sc-EGD was performed with the Pentax small-caliber endoscope and c-EGD with the conventional Olympus endoscope. Intravenous midazolam was administered before c-EGD. The staff endoscopist performing c-EGD was blinded to the findings of sc-EGD performed by the staff investigator. The subjects were asked to comment on willingness to undergo the procedure again if medically indicated, as well as the degree of choking, sore throat, and discomfort on a scale of 1–10 (1, most acceptable/ least severe; 10, least acceptable/most severe). Unsedated sc-EGD was considered accurate if its clinically important findings agreed with those of c-EGD in $95% of cases and tolerable if $90% of patients completed the examination and were willing to undergo the procedure again if medically indicated. No biopsies were performed in the sc-EGD group.
Statistical Analysis A descriptive analysis was performed to determine the diagnostic accuracy of sc-EGD compared with c-EGD. The tolerability of sc-EGD compared with c-EGD as determined by the degree of choking, sore throat, discomfort, and overall acceptability was assessed by the t test for paired samples assuming equal variances. A P value #0.05 was considered significant.
Results Phase 1: Determining the Feasibility of Sedated sc-EGD The age of the 20 volunteers enrolled in the first phase of the study ranged from 20 to 47 years with a mean of 34.5 and a median of 36.5 years. Eighty percent of the subjects were female. The second portion of the duodenum was reached in all cases without difficulty. The subjects were asked to complete a questionnaire immediately before their discharge from the recovery area to determine the tolerability of sc-EGD with sedation. Most volunteers expressed little discomfort, choking, or sore
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throat (Table 1). The median degree of choking, sore throat, and discomfort was rated as 1 on a scale of 1–10, 10 being least tolerable. All subjects were willing to undergo the procedure again if medically indicated. Phase 2: Determining the Tolerability of Unsedated sc-EGD The age of the 20 volunteers enrolled in the second phase of the study ranged from 20 to 58 years with a mean of 36 years and a median of 39 years. Seventy-five percent of the subjects were female. The procedure was technically feasible in all cases. All participants found the procedure tolerable and were willing to undergo sc-EGD without sedation if medically indicated. Compared with sedated sc-EGD, unsedated sc-EGD was associated with slightly increased choking and discomfort (Table 1). The degree of sore throat was not significantly different, but the overall acceptability was slightly better in the sedated sc-EGD arm. Phase 3: Determining the Diagnostic Accuracy of Sedated sc-EGD The age of the 50 participants ranged from 22 to 73 years with a mean of 53 and a median of 54 years (Table 2). One half of the patients were female. The most common single indications for upper endoscopy were dyspepsia (34%), suspected esophageal pain (22%), iron deficiency anemia (8%), abnormal radiographic finding (8%), Barrett’s recheck (6%), and weight loss (6%). The second portion of the duodenum was reached in all cases. Compared with sedated c-EGD, 96% of significant upper gastrointestinal lesions were correctly identified by sedated sc-EGD. An anastomotic stricture requiring dilataTable 1. Tolerability of Sedated and Unsedated sc-EGD in a Group of Volunteers
No. of subjects Age (yr )a Sex (% female) a Choking Sore throat a Discomfort a Acceptability a Willingness to repeat
Sedated sc-EGD
Unsedated sc-EGD
20 34.5 6 2.0; 37; 20–47 80% 1.2 6 0.1; 1; 1–2 1.5 6 0.3; 1; 1–6 1.3 6 0.2; 1; 1–4 1.2 6 0.1; 1; 1–3 100%
20 36.0 6 2.5; 39, 20–58 75% 2.9 6 0.4; 3; 1–6 1.6 6 0.2; 1; 1–5 2.5 6 0.2; 2; 1–5 2.3 6 0.3; 2; 1–5 100%
P value NS NS ,0.0001 NS ,0.005 ,0.005 NS
NOTE. The degree of choking, sore throat, discomfort, and acceptability was assessed on a scale of 1–10 (1, least severe/most acceptable; 10, most severe/least acceptable). Subjects were also asked to express their willingness to undergo the procedure again if medically indicated. Statistical analysis was performed using the t test for paired samples assuming equal variances. A P value of #0.05 was considered significant. aValues represent mean 6 SEM; median; and range.
Table 2. Indications, Endoscopic Findings, and Diagnostic Accuracy of Sedated sc-EGD Compared With Sedated c-EGD No. of subjects Age (yr )a Sex (% female) Indications Persistent esophageal pain Barrett’s esophagus recheck Suspected Barrett’s esophagus Dyspepsia Gastric ulcer follow-up Unexplained weight loss Iron deficiency anemia Positive fecal blood test Hematemesis/melena, not active Suspected portal hypertension/ varices Abnormal upper GI radiograph Persistent vomiting Gastric malignancy follow-up
Major findings Esophagitis Barrett’s esophagus Schatzki’s ring Anastomotic or peptic stricture Diaphragmatic hernia Ivor–Lewis Gastric ulcer Gastroenterostomy Duodenal ulcer Duodenal polyp Total major findings Diagnostic accuracy
50 53.3 6 1.8; 54; 22–73 50% n
(%)
11 3 1 17 1 3 4 1 1
22 6 2 34 2 6 8 2 2
2 4 1 1
4 8 2 2
Sedated c-EGD
Sedated sc-EGD
9 3 3 1 3 1 3 1 1 1 45
9 3 3 0 3 1 3 1 1 0 43 96%
GI, gastrointestinal. represent mean 6 SEM; median; and range.
aValues
tion and a villous adenoma in the second portion of the duodenum were not identified using the sc-EGD. Phase 4: Determining the Diagnostic Accuracy and Tolerability of Unsedated sc-EGD The 40 patients recruited in the final phase of the study had a median age of 54 years, a mean age of 51 years, and an age range of 25–70 years (Table 3). Fortythree percent of the patients were female. The median dose of midazolam used for sedated c-EGD was 5 mg (mean 6 SEM, 4.6 6 0.4 mg). Unsedated sc-EGD was technically feasible in 38 of 40 patients. It failed in 1 case because of poor tolerability and in another case because of inability to advance the endoscope into the postbulbar duodenum. Compared with sedated c-EGD, 97% of significant upper gastrointestinal lesions were correctly identified by unsedated sc-EGD. In 1 noncirrhotic patient, prominent gastric veins could not be reliably
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Table 3. Indications, Endoscopic Findings, and Diagnostic Accuracy of Unsedated sc-EGD Compared With Sedated c-EGD No. of subjects Age (yr )a Sex (% female) Indications Persistent esophageal pain Barrett’s esophagus recheck Suspected Barrett’s esophagus Dyspepsia Gastric ulcer follow-up Unexplained weight loss Iron deficiency anemia Persistent vomiting Gastric malignancy follow-up
Major findings Esophagitis Barrett’s esophagus Anastomotic or peptic stricture Diaphragmatic hernia Fundoplication Ivor–Lewis Gastric ulcer Gastric mass Prominent gastric vessels Duodenal deformity Total major findings Diagnostic accuracy aValues
40 51.0 6 2.2; 54; 25–70 43% n
(%)
9 1 1 18 1 2 5 1 2
22.5 2.5 2.5 45 2.5 5.0 12.5 2.5 5.0
Sedated c-EGD
Sedated sc-EGD
9 5 1 10 1 1 1 1 1 2 39
9 5 1 10 1 1 1 1 0 2 38 97%
represent mean 6 SEM; median; and range.
distinguished from prominent folds. Unsedated sc-EGD was associated with slightly increased choking and discomfort (Table 4). The degree of sore throat was not significantly different, and the overall acceptability was slightly better in the sedated c-EGD group. All patients who underwent sedated c-EGD and 98% of those who underwent unsedated sc-EGD were willing to undergo the same procedure again if medically indicated. No statistically significant differences were observed in the tolerability of male subjects compared with female patients. Older age correlated with less choking, sore throat, and discomfort, as well as improved overall acceptability in both genders.
Discussion Several studies have pointed out the advantages of endoscopy without sedation.7,8,10–18 Although EGD is a safe procedure, complications can occur, especially in elderly patients with underlying cardiac or pulmonary disease.5–9 Sedated endoscopy has traditionally been performed in an endoscopy unit, whereas unsedated endoscopy can be conveniently performed as an outpatient procedure in any setting. Unsedated endoscopy
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offers cost-effective incentives. The observation period after a procedure can be minimized, and patients can return to work or drive home after their procedure. Previous studies assessing unsedated upper endoscopy have either involved larger endoscopes, smaller numbers of patients, or were not performed in a blinded fashion to determine the accuracy.11,12 Zaman et al.11 attempted unsedated upper endoscopy in 43 patients. Among these patients, 37 subjects had a complete unsedated examination. Endoscopy was not successful in 6 patients because of severe gagging. The ultrathin endoscope missed 5 of 59 lesions. Three diaphragmatic hernias and 2 gastric erosions could not be identified by unsedated EGD using a 6-mm Olympus XGIF-N200H endoscope. Among the subjects who completed the examination, 81% were willing to undergo the procedure again. Sixty percent of the patients reported no or mild discomfort during insertion, and 73% of patients during the endoscopy. Although they also assessed the image quality, they did not evaluate the tolerability of sedated c-EGD. Furthermore, the accuracy was not assessed in a blinded fashion and some of the procedures were performed by senior fellows in training and not by more experienced staff members. Dean et al.7 assessed the tolerability and diagnostic accuracy of unsedated transnasal upper endoscopy compared with c-EGD in 24 patients. Each patient underwent transnasal unsedated EGD first followed by sedated c-EGD by a second endoscopist blinded to the results of the first endoscopy. They determined the sensitivity to be 89% and the specificity 97% for Table 4. Tolerability of Sedated c-EGD and Unsedated sc-EGD in a Group of Patients Referred for Upper Endoscopy Sedated c-EGD No. of subjects Age (yr )a Sex (% female) Choking a Sore throat a
Unsedated sc-EGD
40 51.0 6 2.2; 54; 25–70 43% 1.8 6 0.3; 1; 1–5 3.7 6 0.4; 3; 1–9 1.8 6 0.2; 1; 1.2 6 0.1; 1; 1–5 1–5.5 Discomfort a 1.9 6 0.3; 1; 1–5 3.7 6 0.4; 4; 1–8 Acceptability a 2.0 6 0.3; 1; 1–7 3.0 6 0.4; 2; 1–8 Examination com40 38 pleted Willingness to 100% 98% repeat
P value
,0.0005 NS ,0.005 ,0.005 NS NS
NOTE. One patient did not tolerate unsedated sc-EGD, and in another case the postbulbar duodenum could not be reached. The degree of choking, sore throat, discomfort, and acceptability was assessed on a scale of 1–10 (1, least severe/most acceptable; 10, most severe/ least acceptable), and subjects were asked to express their willingness to undergo the procedure again if medically indicated. Statistical analysis was performed using the t test for paired samples assuming equal variances. A P value of #0.05 was considered significant. NS, not significant. aValues represent mean 6 SEM; median; and range.
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unsedated transnasal upper endoscopy. More recent studies have compared the tolerability and feasibility of transnasal with transoral intubation, not the assessment of the diagnostic accuracy.15–17 Our results indicate that unsedated upper endoscopy is technically feasible, tolerable, and accurate. The second portion of the duodenum could not be reached because of technical difficulty associated with a smaller caliber and less rigid upper endoscope in only 1 of the 110 study subjects; this was caused by the inability to advance the endoscope through the pylorus. All 20 volunteers and 38 of the 40 patients tolerated unsedated sc-EGD without any significant discomfort. Furthermore, 100% of the volunteers and 98% of the patients were willing to undergo unsedated upper endoscopy again if medically indicated. Compared with c-EGD with sedation, sc-EGD without sedation was only slightly less acceptable. This seemed to be related more to slightly increased discomfort and choking, because the degree of sore throat was not significantly different. The accuracy and image quality of sc-EGD were overall excellent within the various areas of the upper gastrointestinal tract examined. Even without the use of sedation, 97% of the patients were accurately diagnosed by sc-EGD. Although sedated patients may be examined more easily, sedation did not seem to affect the accuracy of sc-EGD in our study. The accuracy of sedated sc-EGD compared with sedated c-EGD was 96% in our study and not significantly different than the accuracy of unsedated sc-EGD. However, limitations may exist with the use of small-caliber endoscopes. Although the overall handling characteristics of the small-caliber endoscope used in this study were excellent, in a few cases it lacked sufficient rigidity to prevent looping in the stomach. The examination of the second portion of the duodenum, therefore, may be restricted with the current instruments. Increased insertion tube rigidity or length can overcome this. We also found it difficult to assess strictures. This seems to be related to the smaller caliber of the endoscope and the ease of advancing the endoscope without any resistance through most strictures, except those with a diameter of ,6 mm. Dean et al.7 also reported a subtle ring at the gastroesophageal junction that could not be appreciated. Image quality was impaired when secretions and bubbles were present. The latter could be overcome by the use of simethicone, either by giving patients simethicone before the procedure as described by Zaman et al.,11 or by adding it to the water bottle for use during endoscopy. The smaller 2-mm instrument channel also allows only the use of pediatric biopsy forceps and snares. This may be one of the major drawbacks, preventing therapeutic activities or obtaining large biopsy specimens. The
GASTROENTEROLOGY Vol. 117, No. 6
adequacy of biopsy specimens using pediatric forceps through the small-caliber endoscope was not assessed in our study. Besides the technical feasibility, tolerability, and accuracy, several other issues need to be addressed to determine the future role of unsedated transoral sc-EGD in practice. The feasibility of therapeutic interventions without sedation needs to be evaluated if the technique is to have a more widespread use. Furthermore, the ideal population for unsedated endoscopy needs to be characterized. Cost analyses also need to be performed to establish the cost-effectiveness of unsedated endoscopy.
References 1. Solomon SA, Kajla VK, Banerjee AK. Can the elderly tolerate endoscopy without sedation? J R Coll Physicians Lond 1994;28: 407–410. 2. Walker B, Smith MJ. Upper gastrointestinal endoscopy: a survey of patients’ impressions. Postgrad Med J 1978;54:253–256. 3. Beavis AK, Labrooy S, Misiewicz JJ. Evaluation of one visit endoscopy clinic for patients with dyspepsia. BMJ 1979;1:1387– 1389. 4. Thompson DG, Lennard-Jones JE, Evans SJ, Cowan RE, Murray RS, Wright JT. Patients appreciate premedication for endoscopy. Lancet 1980;2:469–470. 5. Bell GD, McCloy RF, Charlton JE, Campbell D, Dent NA, Gear MW, Logan RF, Swan CH. Recommendations for standards of sedation and patient monitoring during gastrointestinal endoscopy. Gut 1991;32:823–827. 6. Solomon SA, Isaac T, Banerjee AK. Oxygen desaturation during endoscopy in the elderly. J R Coll Physicians Lond 1993;27: 16–18. 7. Dean R, Dua K, Massey B, Berger W, Hogan WJ, Shaker R. A comparative study of unsedated transnasal esophagogastroduodenoscopy and conventional EGD. Gastrointest Endosc 1996;44: 422–424. 8. Holm C, Christensen M, Rasmussen V, Schulze S, Rosenberg J. Hypoxemia and myocardial ischemia during colonoscopy. Scand J Gastroenterol 1998;33:769–772. 9. Martin L. Predictive factors of oxygen desaturation during upper gastrointestinal endoscopy in nonsedated patients. Gastrointest Endosc 1998;48:143–147. 10. Shaker R. Transnasal, unsedated pharyngoesophagogastroduodenoscopy (T-EGD). Gastrointest Endosc 1994;40:346–348. 11. Zaman A, Hapke R, Sahagun G, Katon RM. Unsedated peroral endoscopy with a video ultrathin endoscope: patient acceptance, tolerance, and diagnostic accuracy. Am J Gastroenterol 1998;93: 1260–1263. 12. Al-Altrakchi HA. Upper gastrointestinal endoscopy without sedation: a prospective study of 2000 examinations. Gastrointest Endosc 1989;35:79–81. 13. Mulcahy HE, Alstead EM, McKenzie C, Riches A, Kiely M, Farthing MJG, Fairclough PD. A randomized trial of a 5.5 mm versus 9.5 mm diameter videogastroscope in unsedated upper GI endoscopy. Abstract presented at the 1997 Annual ASGE/AGA Meeting, Washington, D.C. 14. Pereira SP, Hussaini SH, Hanson PJV, Wilkinson ML, Sladen GE. Endoscopy: throat spray or sedation? J R Coll Physicians Lond 1994;28:411–414. 15. Zaman A, Hahn M, Hapke R, Knigge K, Fennerty MB, Katon RM. A randomized trial of peroral versus transnasal unsedated endoscopy using an ultrathin videoendoscope. Gastrointest Endosc 1999;49:279–284.
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16. Dumortier J, Ponchon T, Scoazec J-Y, Moulinier B, Zarka F, Paliard P, Lambert R. Prospective evaluation of transnasal esophagogastroduodenoscopy: feasibility and study on performance and tolerance. Gastrointest Endosc 1999;49:285–291. 17. Craig A, Hanlon J, Dent J, Schoeman M. A comparison of transnasal and transoral endoscopy with small-diameter endoscopes in unsedated patients. Gastrointest Endosc 1999;49: 292–296. 18. Saeian K, Townsend WF, Rochling FA, Bardan E, Dua K, Phadnis S, Dunn BE, Darnell K, Shaker R. Unsedated transnasal EGD: an alternative approach to conventional esophagogastroduodenoscopy for documenting Helicobacter pylori eradication. Gastrointest Endosc 1999;49:297–301. 19. Froehlich F, Gonvers JJ, Fried M. Conscious sedation, clinically
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relevant complications and monitoring of endoscopy: results of nationwide survey in Switzerland. Endoscopy 1994;26:231–234. 20. Hedenbro JL, Lindbolm A. Patient attitudes to sedation for diagnostic upper endoscopy. Scand J Gastroenterol 1991;26: 1115–1120.
Received May 27, 1999. Accepted August 10, 1999. Address requests for reprints to: Keith D. Lindor, M.D., Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, 200 First Street Southwest, Rochester, Minnesota 55905. e-mail: [email protected]; fax: (507) 266-4531. Supported in part by Pentax Precision Instrument Corp., Orangeburg, New York.
Unsedated Small-Caliber Esophagogastroduodenoscopy (EGD) Versus Conventional EGD: A Comparative Study DARIUS SORBI, CHRISTOPHER J. GOSTOUT, JESSICA HENRY, and KEITH D. LINDOR Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota
See editorial on page 1492. Background & Aims: Significant portions of the cost and complications of esophagogastroduodenoscopy (EGD) are related to sedation. This study aimed to assess the feasibility, acceptability, and accuracy of unsedated small-caliber transoral EGD (sc-EGD). Methods: A 4-phase study was performed in healthy volunteers and patients. Phases 1 and 2 involved assessment of the technical feasibility of sedated sc-EGD and the tolerability of unsedated sc-EGD, respectively, in volunteers. Subsequently, the technical feasibility, tolerability, and diagnostic accuracy of sedated and unsedated sc-EGD were determined by having each patient undergo sc-EGD (Pentax EG-1840) with (phase 3) and without (phase 4) sedation, followed by sedated conventional EGD (c-EGD) (Olympus GIF-100 or GIF-Q140) by a staff endoscopist blinded to the findings of the sc-EGD. The t test for paired samples was used for statistical analysis. A P value of F0.05 was considered significant. Results: Sedated and unsedated sc-EGD were technically feasible and tolerable in all volunteers. In patients, compared with sedated c-EGD, sedated and unsedated sc-EGD were 96% and 97% accurate, respectively. The overall acceptability of unsedated sc-EGD was only slightly worse than that of sedated c-EGD (median, 2 vs. 1 on a scale of 1–10). After unsedated sc-EGD, 98% of patients expressed willingness to undergo the procedure again. No complications were observed during any phase of the study. Conclusions: Unsedated sc-EGD is technically feasible, tolerable, and accurate. It can potentially decrease the costs and complications of sedated conventional EGD.
sophagogastroduodenoscopy (EGD) is a safe procedure.1 Although studies have suggested that endoscopy with sedation is more comfortable than without sedation,2–4 a significant portion of complications may be related to sedation. Elderly patients and individuals with underlying cardiopulmonary disease are at a greater risk.5–9 Furthermore, the use of sedation requires physiological monitoring and, at some centers, anesthesia
E
participation.5 Sedation also results in increased loss of work on the day of endoscopy7 and the need for a person to accompany the patient home after the procedure. The feasibility, tolerability, and diagnostic accuracy of unsedated EGD in normal volunteers as well as in patients with upper gastrointestinal symptoms have been studied.7,8,10–20 Unsedated endoscopy is the general practice in Asia and Latin America, as well as in some European countries.12,14,16,18–20 Although the sensitivity of transnasal, or transoral, unsedated EGD may be lower, the specificity seems to be comparable with sedated conventional EGD (c-EGD). Unsedated EGD also seems to be tolerable and potentially safer and more costeffective. The primary aim of this investigation was to assess the technical feasibility, tolerability, and diagnostic accuracy of small-caliber EGD (sc-EGD) compared with conventional upper endoscopy in healthy volunteers and patients.
Materials and Methods Esophagogastroduodenoscopes Small-caliber endoscopy was performed by using a Pentax small-caliber esophagogastroduodenoscope (Pentax EG1840; Pentax Precision Instrument Co., Orangeburg, NY) (Figure 1) and conventional endoscopy by the standard Olympus esophagogastroduodenoscope (GIF-100 or GIF-Q140; Olympus Corp., Tokyo, Japan). The Pentax small-caliber endoscope has a 6-mm insertion tube outer diameter and a 2-mm biopsy channel. The Olympus GIF-100 has a 9.5-mm insertion tube outer diameter and a 2.8-mm biopsy channel. The Olympus GIF-Q140 has a 10.5-mm insertion tube outer diameter and a 2.8-mm biopsy channel. All are end-viewing videoendoscopes with a field of view of 120°. The tip flexion capability was 180° up/down, and 160° right/left for all instruments. The optical quality of the small-caliber endoscope is good (Figure 2). Abbreviations used in this paper: c-EGD, conventional EGD; EGD, esophagogastroduodenoscopy; sc-EGD, small-caliber EGD. r 1999 by the American Gastroenterological Association 0016-5085/99/$10.00
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Figure 2. Image quality. Endoscopic image of an esophageal stricture as viewed by the (A) small-caliber and (B) conventional esophagogastroduodenoscopes.
Study Design
Figure 1. Small-caliber upper endoscope. (A) The distal tips of the small-caliber and the conventional esophagogastroduodenoscopes are shown for comparison, along with (B) the handle of the smallcaliber endoscope.
This multiphase prospective study was approved by the Institutional Review Board of the Mayo Clinic and Foundation. Phases 1 and 2 involved evaluation of the technical feasibility of sedated sc-EGD and the tolerability of unsedated sc-EGD in healthy volunteers, respectively. The technical feasibility and diagnostic accuracy of sedated sc-EGD compared with sedated c-EGD, and the tolerability and diagnostic accuracy of unsedated sc-EGD compared with sedated c-EGD, were assessed in phases 3 and 4, respectively. The staff investigators were experienced in performing both sedated conventional and unsedated small-caliber upper endoscopy.
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Phase 1: determining the feasibility of sedated scEGD.
Twenty healthy volunteers (age, 18–70 years) were studied to determine the feasibility of sedated sc-EGD for diagnostic purposes. All procedures were performed by 1 of the 2 staff investigators using the Pentax small-caliber endoscope. All subjects had their pharynx sprayed with 20% benzocaine. For intravenous sedation, midazolam was used as a slow injection in a sufficient dose to cause drowsiness or slurred speech. The procedure was defined as technically feasible if the endoscope could be passed into the second portion of the duodenum $90% of the time. Phase 2: determining the tolerability of unsedated sc-EGD. After establishing the technical feasibility of sedated
sc-EGD, 20 other volunteers (age, 18–70 years) were studied to determine the tolerability and feasibility of unsedated sc-EGD. Subjects underwent sc-EGD by 1 of the 2 experienced staff investigators. Only topical 20% benzocaine spray was used to anesthetize the pharynx. After the procedure, subjects were asked to comment on willingness to undergo the procedure again if medically indicated. Choking sensation, sore throat, discomfort, and overall acceptability were assessed on a scale of 1–10 (1, most acceptable/least severe; 10, least acceptable/most severe). Unsedated sc-EGD was defined as technically feasible and tolerable if the second portion of the duodenum was reached in $90% of the cases and $90% of the subjects were willing to have the procedure again if medically indicated. Phase 3: determining the diagnostic accuracy of sedated sc-EGD. Fifty patients (age, 18–70 years) referred to
our Gastrointestinal Diagnostic Unit for evaluation of upper gastrointestinal symptoms agreed to participate in the third phase of the study. The endoscopic indications considered for this study were (1) abnormal esophagus or gastroduodenal radiograph, (2) Barrett’s recheck, (3) familial polyposis, (4) gastric polyp recheck, (5) gastric ulcer follow-up, (6) hematemesis and/or melena, not active, (7) iron deficiency anemia, (8) persistent dyspepsia or pain despite therapy, (9) persistent esophageal pain despite therapy, (10) persistent vomiting, (11) positive fecal blood test result, (12) suspected Barrett’s esophagus, (13) suspected portal hypertension/varices, and (14) unexplained weight loss associated with gastrointestinal symptoms. The patients with the following indications were excluded: (1) dysphagia, (2) hematemesis, active, and (3) varices, requiring possible endoscopic therapy. The patients agreeing to participate in the study underwent sedated sc-EGD followed by c-EGD. One of the staff investigators performed sc-EGD, and another staff endoscopist blinded to the findings of the first endoscopy performed the second procedure. Details of age, sex, medical history, prior history of upper endoscopy, and the indication for EGD were recorded. All patients had their pharynx sprayed with 20% benzocaine. Intravenous midazolam was given for sedation. The standard Olympus esophagogastroduodenoscope was used for c-EGD. The findings of sc-EGD were compared with the findings of c-EGD to determine the diagnostic accuracy in detecting significant upper gastrointestinal lesions. Significant lesions
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were defined as large diaphragmatic hernias ($5 cm), stricture requiring dilatation, mass lesions, ulcers $5 mm, Barrett’s esophagus $3 cm, moderate to severe esophagitis, and esophageal or gastric varices. Sedated sc-EGD was considered accurate if its clinically significant findings agreed with those of c-EGD in $95% of cases. No biopsies were performed in the sc-EGD group. Phase 4: determining the diagnostic accuracy and tolerability of unsedated sc-EGD. Forty patients (age, 18–70
years) referred to our Gastrointestinal Diagnostic Unit for evaluation of upper gastrointestinal symptoms underwent unsedated sc-EGD performed by 1 of the 2 staff investigators followed by sedated c-EGD by another staff endoscopist. The exclusion and inclusion criteria are as listed under Phase 3. Details of age, sex, medical history, prior history of endoscopy, and the indication for EGD were recorded. All patients had their pharynx sprayed with 20% benzocaine. Sc-EGD was performed with the Pentax small-caliber endoscope and c-EGD with the conventional Olympus endoscope. Intravenous midazolam was administered before c-EGD. The staff endoscopist performing c-EGD was blinded to the findings of sc-EGD performed by the staff investigator. The subjects were asked to comment on willingness to undergo the procedure again if medically indicated, as well as the degree of choking, sore throat, and discomfort on a scale of 1–10 (1, most acceptable/ least severe; 10, least acceptable/most severe). Unsedated sc-EGD was considered accurate if its clinically important findings agreed with those of c-EGD in $95% of cases and tolerable if $90% of patients completed the examination and were willing to undergo the procedure again if medically indicated. No biopsies were performed in the sc-EGD group.
Statistical Analysis A descriptive analysis was performed to determine the diagnostic accuracy of sc-EGD compared with c-EGD. The tolerability of sc-EGD compared with c-EGD as determined by the degree of choking, sore throat, discomfort, and overall acceptability was assessed by the t test for paired samples assuming equal variances. A P value #0.05 was considered significant.
Results Phase 1: Determining the Feasibility of Sedated sc-EGD The age of the 20 volunteers enrolled in the first phase of the study ranged from 20 to 47 years with a mean of 34.5 and a median of 36.5 years. Eighty percent of the subjects were female. The second portion of the duodenum was reached in all cases without difficulty. The subjects were asked to complete a questionnaire immediately before their discharge from the recovery area to determine the tolerability of sc-EGD with sedation. Most volunteers expressed little discomfort, choking, or sore
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throat (Table 1). The median degree of choking, sore throat, and discomfort was rated as 1 on a scale of 1–10, 10 being least tolerable. All subjects were willing to undergo the procedure again if medically indicated. Phase 2: Determining the Tolerability of Unsedated sc-EGD The age of the 20 volunteers enrolled in the second phase of the study ranged from 20 to 58 years with a mean of 36 years and a median of 39 years. Seventy-five percent of the subjects were female. The procedure was technically feasible in all cases. All participants found the procedure tolerable and were willing to undergo sc-EGD without sedation if medically indicated. Compared with sedated sc-EGD, unsedated sc-EGD was associated with slightly increased choking and discomfort (Table 1). The degree of sore throat was not significantly different, but the overall acceptability was slightly better in the sedated sc-EGD arm. Phase 3: Determining the Diagnostic Accuracy of Sedated sc-EGD The age of the 50 participants ranged from 22 to 73 years with a mean of 53 and a median of 54 years (Table 2). One half of the patients were female. The most common single indications for upper endoscopy were dyspepsia (34%), suspected esophageal pain (22%), iron deficiency anemia (8%), abnormal radiographic finding (8%), Barrett’s recheck (6%), and weight loss (6%). The second portion of the duodenum was reached in all cases. Compared with sedated c-EGD, 96% of significant upper gastrointestinal lesions were correctly identified by sedated sc-EGD. An anastomotic stricture requiring dilataTable 1. Tolerability of Sedated and Unsedated sc-EGD in a Group of Volunteers
No. of subjects Age (yr )a Sex (% female) a Choking Sore throat a Discomfort a Acceptability a Willingness to repeat
Sedated sc-EGD
Unsedated sc-EGD
20 34.5 6 2.0; 37; 20–47 80% 1.2 6 0.1; 1; 1–2 1.5 6 0.3; 1; 1–6 1.3 6 0.2; 1; 1–4 1.2 6 0.1; 1; 1–3 100%
20 36.0 6 2.5; 39, 20–58 75% 2.9 6 0.4; 3; 1–6 1.6 6 0.2; 1; 1–5 2.5 6 0.2; 2; 1–5 2.3 6 0.3; 2; 1–5 100%
P value NS NS ,0.0001 NS ,0.005 ,0.005 NS
NOTE. The degree of choking, sore throat, discomfort, and acceptability was assessed on a scale of 1–10 (1, least severe/most acceptable; 10, most severe/least acceptable). Subjects were also asked to express their willingness to undergo the procedure again if medically indicated. Statistical analysis was performed using the t test for paired samples assuming equal variances. A P value of #0.05 was considered significant. aValues represent mean 6 SEM; median; and range.
Table 2. Indications, Endoscopic Findings, and Diagnostic Accuracy of Sedated sc-EGD Compared With Sedated c-EGD No. of subjects Age (yr )a Sex (% female) Indications Persistent esophageal pain Barrett’s esophagus recheck Suspected Barrett’s esophagus Dyspepsia Gastric ulcer follow-up Unexplained weight loss Iron deficiency anemia Positive fecal blood test Hematemesis/melena, not active Suspected portal hypertension/ varices Abnormal upper GI radiograph Persistent vomiting Gastric malignancy follow-up
Major findings Esophagitis Barrett’s esophagus Schatzki’s ring Anastomotic or peptic stricture Diaphragmatic hernia Ivor–Lewis Gastric ulcer Gastroenterostomy Duodenal ulcer Duodenal polyp Total major findings Diagnostic accuracy
50 53.3 6 1.8; 54; 22–73 50% n
(%)
11 3 1 17 1 3 4 1 1
22 6 2 34 2 6 8 2 2
2 4 1 1
4 8 2 2
Sedated c-EGD
Sedated sc-EGD
9 3 3 1 3 1 3 1 1 1 45
9 3 3 0 3 1 3 1 1 0 43 96%
GI, gastrointestinal. represent mean 6 SEM; median; and range.
aValues
tion and a villous adenoma in the second portion of the duodenum were not identified using the sc-EGD. Phase 4: Determining the Diagnostic Accuracy and Tolerability of Unsedated sc-EGD The 40 patients recruited in the final phase of the study had a median age of 54 years, a mean age of 51 years, and an age range of 25–70 years (Table 3). Fortythree percent of the patients were female. The median dose of midazolam used for sedated c-EGD was 5 mg (mean 6 SEM, 4.6 6 0.4 mg). Unsedated sc-EGD was technically feasible in 38 of 40 patients. It failed in 1 case because of poor tolerability and in another case because of inability to advance the endoscope into the postbulbar duodenum. Compared with sedated c-EGD, 97% of significant upper gastrointestinal lesions were correctly identified by unsedated sc-EGD. In 1 noncirrhotic patient, prominent gastric veins could not be reliably
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Table 3. Indications, Endoscopic Findings, and Diagnostic Accuracy of Unsedated sc-EGD Compared With Sedated c-EGD No. of subjects Age (yr )a Sex (% female) Indications Persistent esophageal pain Barrett’s esophagus recheck Suspected Barrett’s esophagus Dyspepsia Gastric ulcer follow-up Unexplained weight loss Iron deficiency anemia Persistent vomiting Gastric malignancy follow-up
Major findings Esophagitis Barrett’s esophagus Anastomotic or peptic stricture Diaphragmatic hernia Fundoplication Ivor–Lewis Gastric ulcer Gastric mass Prominent gastric vessels Duodenal deformity Total major findings Diagnostic accuracy aValues
40 51.0 6 2.2; 54; 25–70 43% n
(%)
9 1 1 18 1 2 5 1 2
22.5 2.5 2.5 45 2.5 5.0 12.5 2.5 5.0
Sedated c-EGD
Sedated sc-EGD
9 5 1 10 1 1 1 1 1 2 39
9 5 1 10 1 1 1 1 0 2 38 97%
represent mean 6 SEM; median; and range.
distinguished from prominent folds. Unsedated sc-EGD was associated with slightly increased choking and discomfort (Table 4). The degree of sore throat was not significantly different, and the overall acceptability was slightly better in the sedated c-EGD group. All patients who underwent sedated c-EGD and 98% of those who underwent unsedated sc-EGD were willing to undergo the same procedure again if medically indicated. No statistically significant differences were observed in the tolerability of male subjects compared with female patients. Older age correlated with less choking, sore throat, and discomfort, as well as improved overall acceptability in both genders.
Discussion Several studies have pointed out the advantages of endoscopy without sedation.7,8,10–18 Although EGD is a safe procedure, complications can occur, especially in elderly patients with underlying cardiac or pulmonary disease.5–9 Sedated endoscopy has traditionally been performed in an endoscopy unit, whereas unsedated endoscopy can be conveniently performed as an outpatient procedure in any setting. Unsedated endoscopy
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offers cost-effective incentives. The observation period after a procedure can be minimized, and patients can return to work or drive home after their procedure. Previous studies assessing unsedated upper endoscopy have either involved larger endoscopes, smaller numbers of patients, or were not performed in a blinded fashion to determine the accuracy.11,12 Zaman et al.11 attempted unsedated upper endoscopy in 43 patients. Among these patients, 37 subjects had a complete unsedated examination. Endoscopy was not successful in 6 patients because of severe gagging. The ultrathin endoscope missed 5 of 59 lesions. Three diaphragmatic hernias and 2 gastric erosions could not be identified by unsedated EGD using a 6-mm Olympus XGIF-N200H endoscope. Among the subjects who completed the examination, 81% were willing to undergo the procedure again. Sixty percent of the patients reported no or mild discomfort during insertion, and 73% of patients during the endoscopy. Although they also assessed the image quality, they did not evaluate the tolerability of sedated c-EGD. Furthermore, the accuracy was not assessed in a blinded fashion and some of the procedures were performed by senior fellows in training and not by more experienced staff members. Dean et al.7 assessed the tolerability and diagnostic accuracy of unsedated transnasal upper endoscopy compared with c-EGD in 24 patients. Each patient underwent transnasal unsedated EGD first followed by sedated c-EGD by a second endoscopist blinded to the results of the first endoscopy. They determined the sensitivity to be 89% and the specificity 97% for Table 4. Tolerability of Sedated c-EGD and Unsedated sc-EGD in a Group of Patients Referred for Upper Endoscopy Sedated c-EGD No. of subjects Age (yr )a Sex (% female) Choking a Sore throat a
Unsedated sc-EGD
40 51.0 6 2.2; 54; 25–70 43% 1.8 6 0.3; 1; 1–5 3.7 6 0.4; 3; 1–9 1.8 6 0.2; 1; 1.2 6 0.1; 1; 1–5 1–5.5 Discomfort a 1.9 6 0.3; 1; 1–5 3.7 6 0.4; 4; 1–8 Acceptability a 2.0 6 0.3; 1; 1–7 3.0 6 0.4; 2; 1–8 Examination com40 38 pleted Willingness to 100% 98% repeat
P value
,0.0005 NS ,0.005 ,0.005 NS NS
NOTE. One patient did not tolerate unsedated sc-EGD, and in another case the postbulbar duodenum could not be reached. The degree of choking, sore throat, discomfort, and acceptability was assessed on a scale of 1–10 (1, least severe/most acceptable; 10, most severe/ least acceptable), and subjects were asked to express their willingness to undergo the procedure again if medically indicated. Statistical analysis was performed using the t test for paired samples assuming equal variances. A P value of #0.05 was considered significant. NS, not significant. aValues represent mean 6 SEM; median; and range.
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unsedated transnasal upper endoscopy. More recent studies have compared the tolerability and feasibility of transnasal with transoral intubation, not the assessment of the diagnostic accuracy.15–17 Our results indicate that unsedated upper endoscopy is technically feasible, tolerable, and accurate. The second portion of the duodenum could not be reached because of technical difficulty associated with a smaller caliber and less rigid upper endoscope in only 1 of the 110 study subjects; this was caused by the inability to advance the endoscope through the pylorus. All 20 volunteers and 38 of the 40 patients tolerated unsedated sc-EGD without any significant discomfort. Furthermore, 100% of the volunteers and 98% of the patients were willing to undergo unsedated upper endoscopy again if medically indicated. Compared with c-EGD with sedation, sc-EGD without sedation was only slightly less acceptable. This seemed to be related more to slightly increased discomfort and choking, because the degree of sore throat was not significantly different. The accuracy and image quality of sc-EGD were overall excellent within the various areas of the upper gastrointestinal tract examined. Even without the use of sedation, 97% of the patients were accurately diagnosed by sc-EGD. Although sedated patients may be examined more easily, sedation did not seem to affect the accuracy of sc-EGD in our study. The accuracy of sedated sc-EGD compared with sedated c-EGD was 96% in our study and not significantly different than the accuracy of unsedated sc-EGD. However, limitations may exist with the use of small-caliber endoscopes. Although the overall handling characteristics of the small-caliber endoscope used in this study were excellent, in a few cases it lacked sufficient rigidity to prevent looping in the stomach. The examination of the second portion of the duodenum, therefore, may be restricted with the current instruments. Increased insertion tube rigidity or length can overcome this. We also found it difficult to assess strictures. This seems to be related to the smaller caliber of the endoscope and the ease of advancing the endoscope without any resistance through most strictures, except those with a diameter of ,6 mm. Dean et al.7 also reported a subtle ring at the gastroesophageal junction that could not be appreciated. Image quality was impaired when secretions and bubbles were present. The latter could be overcome by the use of simethicone, either by giving patients simethicone before the procedure as described by Zaman et al.,11 or by adding it to the water bottle for use during endoscopy. The smaller 2-mm instrument channel also allows only the use of pediatric biopsy forceps and snares. This may be one of the major drawbacks, preventing therapeutic activities or obtaining large biopsy specimens. The
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adequacy of biopsy specimens using pediatric forceps through the small-caliber endoscope was not assessed in our study. Besides the technical feasibility, tolerability, and accuracy, several other issues need to be addressed to determine the future role of unsedated transoral sc-EGD in practice. The feasibility of therapeutic interventions without sedation needs to be evaluated if the technique is to have a more widespread use. Furthermore, the ideal population for unsedated endoscopy needs to be characterized. Cost analyses also need to be performed to establish the cost-effectiveness of unsedated endoscopy.
References 1. Solomon SA, Kajla VK, Banerjee AK. Can the elderly tolerate endoscopy without sedation? J R Coll Physicians Lond 1994;28: 407–410. 2. Walker B, Smith MJ. Upper gastrointestinal endoscopy: a survey of patients’ impressions. Postgrad Med J 1978;54:253–256. 3. Beavis AK, Labrooy S, Misiewicz JJ. Evaluation of one visit endoscopy clinic for patients with dyspepsia. BMJ 1979;1:1387– 1389. 4. Thompson DG, Lennard-Jones JE, Evans SJ, Cowan RE, Murray RS, Wright JT. Patients appreciate premedication for endoscopy. Lancet 1980;2:469–470. 5. Bell GD, McCloy RF, Charlton JE, Campbell D, Dent NA, Gear MW, Logan RF, Swan CH. Recommendations for standards of sedation and patient monitoring during gastrointestinal endoscopy. Gut 1991;32:823–827. 6. Solomon SA, Isaac T, Banerjee AK. Oxygen desaturation during endoscopy in the elderly. J R Coll Physicians Lond 1993;27: 16–18. 7. Dean R, Dua K, Massey B, Berger W, Hogan WJ, Shaker R. A comparative study of unsedated transnasal esophagogastroduodenoscopy and conventional EGD. Gastrointest Endosc 1996;44: 422–424. 8. Holm C, Christensen M, Rasmussen V, Schulze S, Rosenberg J. Hypoxemia and myocardial ischemia during colonoscopy. Scand J Gastroenterol 1998;33:769–772. 9. Martin L. Predictive factors of oxygen desaturation during upper gastrointestinal endoscopy in nonsedated patients. Gastrointest Endosc 1998;48:143–147. 10. Shaker R. Transnasal, unsedated pharyngoesophagogastroduodenoscopy (T-EGD). Gastrointest Endosc 1994;40:346–348. 11. Zaman A, Hapke R, Sahagun G, Katon RM. Unsedated peroral endoscopy with a video ultrathin endoscope: patient acceptance, tolerance, and diagnostic accuracy. Am J Gastroenterol 1998;93: 1260–1263. 12. Al-Altrakchi HA. Upper gastrointestinal endoscopy without sedation: a prospective study of 2000 examinations. Gastrointest Endosc 1989;35:79–81. 13. Mulcahy HE, Alstead EM, McKenzie C, Riches A, Kiely M, Farthing MJG, Fairclough PD. A randomized trial of a 5.5 mm versus 9.5 mm diameter videogastroscope in unsedated upper GI endoscopy. Abstract presented at the 1997 Annual ASGE/AGA Meeting, Washington, D.C. 14. Pereira SP, Hussaini SH, Hanson PJV, Wilkinson ML, Sladen GE. Endoscopy: throat spray or sedation? J R Coll Physicians Lond 1994;28:411–414. 15. Zaman A, Hahn M, Hapke R, Knigge K, Fennerty MB, Katon RM. A randomized trial of peroral versus transnasal unsedated endoscopy using an ultrathin videoendoscope. Gastrointest Endosc 1999;49:279–284.
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16. Dumortier J, Ponchon T, Scoazec J-Y, Moulinier B, Zarka F, Paliard P, Lambert R. Prospective evaluation of transnasal esophagogastroduodenoscopy: feasibility and study on performance and tolerance. Gastrointest Endosc 1999;49:285–291. 17. Craig A, Hanlon J, Dent J, Schoeman M. A comparison of transnasal and transoral endoscopy with small-diameter endoscopes in unsedated patients. Gastrointest Endosc 1999;49: 292–296. 18. Saeian K, Townsend WF, Rochling FA, Bardan E, Dua K, Phadnis S, Dunn BE, Darnell K, Shaker R. Unsedated transnasal EGD: an alternative approach to conventional esophagogastroduodenoscopy for documenting Helicobacter pylori eradication. Gastrointest Endosc 1999;49:297–301. 19. Froehlich F, Gonvers JJ, Fried M. Conscious sedation, clinically
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relevant complications and monitoring of endoscopy: results of nationwide survey in Switzerland. Endoscopy 1994;26:231–234. 20. Hedenbro JL, Lindbolm A. Patient attitudes to sedation for diagnostic upper endoscopy. Scand J Gastroenterol 1991;26: 1115–1120.
Received May 27, 1999. Accepted August 10, 1999. Address requests for reprints to: Keith D. Lindor, M.D., Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, 200 First Street Southwest, Rochester, Minnesota 55905. e-mail: [email protected]; fax: (507) 266-4531. Supported in part by Pentax Precision Instrument Corp., Orangeburg, New York.