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A randomized trial of peroral versus transnasal unsedated endoscopy using an ultrathin videoendoscope
A randomized trial of peroral versus transnasal unsedated endoscopy using an ultrathin videoendoscope Atif Zaman, MD, Martin Hahn, MD, Ronald Hapke, MD, Kandice Knigge, MD, M. Brian Fennerty, MD, Ronald M. Katon, MD Portland, Oregon
Background: Potential advantages of unsedated endoscopy include the prevention of side effects or morbidity related to the use of sedative drugs, less intensive patient monitoring, and less expense. We compared transnasal (T-EGD) with peroral (P-EGD) unsedated endoscopy by using an ultrathin video instrument with respect to patient tolerance and acceptance. Method: Patients were randomized to T-EGD or P-EGD. If the initial route of insertion failed, the patient was crossed over to the other route. If this also failed, the patient underwent endoscopy under conscious sedation with an ultrathin instrument. A questionnaire for tolerance was completed by the patient (a validated 0-10 scale where “0” represents none/well tolerated and “10” represents severe/poorly tolerated). Results: Of 105 recruited patients, 60 consented to undergo unsedated endoscopy. There were 20 men and 11 women (mean age 45 years) in the P-EGD group and 15 men and 14 women (mean age 48 years) in the T-EGD group. Of 35 total P-EGD patients (4 were crossed over T-EGD patients), 34 (97%) completed an unsedated examination. Of 29 T-EGD patients, 25 (86%) had a complete examination. Three T-EGD examinations failed for anatomical reasons; all 3 patients when crossed over to the P-EGD route had a successful examination. One patient was unable to tolerate either route. Between the P-EGD and the T-EGD groups, pre-procedure anxiety (3.6 ± 0.5 vs. 3.0 ± 0.6), discomfort during insertion (2.1 ± 0.5 vs. 3.3 ± 0.7), gagging (4.7 ± 0.5 vs. 3.2 ± 0.6), and overall tolerance (2.4 ± 0.5 vs. 3.8 ± 0.7) were similar (p > 0.05). However, discomfort on insertion was significantly greater in the T-EGD versus the P-EGD group (4.4 ± 0.6 vs. 2.7 ± 0.5: p < 0.05). Eighty-nine percent of P-EGD patients and 69% of T-EGD patients, p = 0.07, were willing to undergo unsedated endoscopy in the future. Conclusion: T-EGD patients experienced significantly more pain on insertion than did P-EGD patients. Otherwise, unsedated endoscopy by either the transnasal or the peroral route is generally well tolerated. In this study it was completed in 59 of 60 patients. (Gastrointest Endosc 1999;49:279-84.) Sedation is routinely used in the United States for patients undergoing upper endoscopic procedures. There has been recent interest in unsedated endoscopy, in part as a result of the development of ultrathin (5 to 6 mm in diameter) fiberoptic and Received July 31, 1998. For revision August 20, 1998. Accepted September 24, 1998. From the Department of Medicine, Division of Gastroenterology, Oregon Health Sciences University, Portland, Oregon. Presented as a poster at the annual meeting of the American Society of Gastrointestinal Endoscopy, May 1998, New Orleans, Louisiana. Reprint requests: Ronald M. Katon, MD, Division of Gastroenterology, PV-310, Oregon Health Sciences University, 3181 SW Sam Jackson Park Drive, Portland, OR 97201. Copyright © 1999 by the American Society for Gastrointestinal Endoscopy. 0016-5107/99/$8.00 + 0 37/1/94669 VOLUME 49, NO. 3, PART 1, 1999
video esophagogastroduodenoscopes.1,2 Unsedated upper endoscopy has several advantages over sedated examinations including the prevention of cardiopulmonary complications related to sedation, less intensive patient monitoring, and less expense. In addition, unsedated endoscopy offers advantages to the patient, including the ability to return to work the same day. Several studies conducted outside the United States have shown that peroral unsedated endoscopy, using standard-diameter upper endoscopes, is well tolerated by patients.3,4 However, there has been a reluctance to perform unsedated endoscopy in the United States because of concerns of poor patient tolerance and acceptance. Mulcahy et al.5 have reported preliminary data showing that patients tolerate peroral unsedated endoscopy with an ultrathin (5.9 mm diameter) endoscope better GASTROINTESTINAL ENDOSCOPY
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than they do with a standard (9.5 mm diameter) upper endoscope. We have shown that unsedated peroral endoscopy using an ultrathin endoscope (N200: Olympus America Inc., Melville, N.Y.) is well tolerated by patients, with 86% completing the examination and with 81% willing to undergo an examination in the future.2 The feasibilty of unsedated transnasal endoscopy in the United States was initially reported by Shaker et al.6 in 1994. Rey et al.7 in a European cohort of 283 patients successfully completed transnasal examinations in 91.2% of patients, with 91.8% of them being willing to undergo subsequent unsedated examinations. Two studies comparing transnasal insertion of an ultrathin endoscope with peroral intubation with a standard endoscope have shown that the transnasal route for unsedated upper endoscopy causes less gagging and is better tolerated overall than the peroral route.8,9 However, few studies of unsedated endoscopy have compared the transnasal and the peroral routes using an ultrathin endoscope for both routes. Rey et al. used 10 healthy volunteers to compare tolerance for transnasal and peroral routes of insertion.10 They noted that patients had significantly more pain on insertion with the transnasal route and significantly more gagging with the peroral route and that patients did not prefer one route over the other. This is the first randomized study in the United States comparing unsedated transnasal and peroral endosocopy using an ultrathin endoscope for both routes. The following parameters were assessed: patient acceptance, patient tolerance, and patient characteristics affecting tolerance. PATIENTS AND METHODS Outpatients were recruited from our hospital’s gastroenterology clinics and the endoscopy unit over a 12month period. All study candidates were being evaluated for upper GI symptoms. Patients were excluded if there was evidence of an acute gastrointestinal hemorrhage, a history of sinus surgery or recurrent sinusitis, any current anticoagulation therapy, dysphagia possibly requiring esophageal dilation, a need for sclerotherapy or band ligation of varices, or surveillance for Barrett’s esophagus. The study was approved by the Institutional Review Board of our university. The Olympus N200 and N230 ultrathin endoscopes (Olympus America Inc., Melville, N.Y.; N200 is the original name, and the later model is designated N230) have an outer diameter of 6 mm, an accessory channel diameter of 2 mm, a total length of 1,245 mm, and a working length of 925 mm. They are forward-viewing instruments, with a 120-degree field. Tip deflection is 180 degrees up and down and 160 degrees left to right. They have an ultraminiature, high-resolution charged-coupled device (CCD) 280
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that generates a black and white image that is converted into color. The ultrathin instruments do not require special cleaning techniques or equipment for disinfection. No mechanical dysfunction was encountered with these instruments during the study period. Endoscopy was performed by either experienced endoscopists or by supervised senior gastroenterology fellows. All endoscopists participating in the study were trained in the transnasal approach by otolaryngologists at our hospital. The otolaryngologists also determined competence of each endoscopist in the transnasal approach. After informed consent was obtained from each patient, unsedated endoscopy was performed with the Olympus N200 or N230. Before the procedure patients assessed their anxiety level on a 0-10 scale where “0” represented no anxiety and “10” represented severe anxiety. Patients randomized to the peroral group received a pharyngeal spray with 20% benzocaine (Beutlich L.P. Pharmaceuticals, Waukegan, Ill.). Patients randomized to the transnasal group received a nasal spray composed of a 1% phenylephrine/4% lidocaine solution. Blood pressure, pulse, cardiac rhythm, and oxygen saturation were monitored and recorded every 5 minutes. After the unsedated examination, patients were asked to complete a questionnaire regarding their tolerance of the procedure in terms of discomfort during insertion and during the remainder of the procedure, as well as their overall tolerance of the procedure. A validated 0-10 pain scale (where “0” was none and “10” was severe) was used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure.11 Overall tolerance was rated on a scale from 0-10, where “0” was good and “10” was poor tolerance. In addition, patients were asked if they would choose to have unsedated endoscopy again (yes/no). The endoscopist then completed a questionnaire assessing the optical quality of the instrument (in the esophagus, the stomach, and the duodenum) and patient tolerance on a 1-10 scale (where “1” is excellent and “10” is poor). The endoscopist considered the examination complete if he or she was able to adequately inspect the upper GI tract. Statistical analysis comparing the transnasal and peroral routes included the Student t test and the Fisher exact test. Univariate and multivariate regression analysis was used for both groups to assess factors (age, gender, and pre-procedure anxiety) affecting patient tolerance and willingness to undergo unsedated examinations in the future.
RESULTS A total of 105 consecutive outpatients undergoing upper endoscopy because of GI symptoms were asked to participate in this study. This number did not reflect all patients undergoing upper endoscopies during the study period, because potential candidates were approached only if the ultrathin instrument and an endoscopist involved in the study were available. Forty-five patients refused to participate in the study. Reasons given included anxiety (n = 18), a fear of gagging (n = 10), not being interested in the study (n = 10), and not wishing to VOLUME 49, NO. 3, PART 1, 1999
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undergo a transnasal procedure (n = 7). The mean age of the patients willing to participate was 46 years (range 21 to 84 years). There were 35 men and 25 women. Initially, 29 patients were randomized into the transnasal group and 31 patients into the peroral group. Indications and endoscopic findings are described in Tables 1 and 2. There were no significant differences between the indications for the two groups. Four of the 29 patients in the transnasal group required crossover to the peroral group. Three patients were crossed over because the ultrathin instrument could not be passed beyond the nasal passage; peroral unsedated endoscopy was successful in all three. The fourth patient, a 25-year-old woman undergoing screening endoscopy for esophageal varices, was crossed over into the peroral group because she could not tolerate the transnasal procedure. This patient also could not tolerate an unsedated or a sedated peroral examination and eventually required endoscopy under general anesthesia. No patient in the peroral group required crossover into the transnasal group. Table 3 shows patient demographics and general examination information for both groups. There were no significant differences in demographics. The duration of the examination was significantly longer in the transnasal group, compared with the peroral group (p = 0.03, Student t test). The duodenum was reached, when attempted (2 patients were undergoing endoscopy for follow-up of gastric ulcers, and it was not necessary to visualize the duodenum), in all patients who successfully completed an unsedated examination. One complication occurred in the transnasal group: A 56-year-old woman undergoing unsedated endoscopy for abdominal pain and early satiety became intolerant, with severe gagging, during the procedure after an easy transnasal intubation. The procedure was terminated, and she was discharged home after an uneventful post-procedure period of observation. Several hours after her discharge, facial swelling developed, and eventually a small proximal esophageal perforation was diagnosed by means of an x-ray swallowing series using water-soluable contrast. Surgical exploration of the neck did not reveal a perforation. She recovered fully from this complication. Table 4 shows data on the endoscopists’ evaluation of the ease of insertion of the instrument, the optical quality of the instrument, and the patients’ tolerance. No significant difference was found between either group. Table 5 shows data on the patients’ own evaluations of the procedure. The only significant difference in this area between the two groups was that patients in the transnasal group had significantly more pain on insertion than those VOLUME 49, NO. 3, PART 1, 1999
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Table 1. Indications for upper endoscopy Transnasal group (n = 29) GERD Dyspepsia Rule out Barrett’s esophagus Abdominal pain Rule out varices Nausea/vomiting Follow-up gastric ulcer Anemia Diarrhea
Peroral group (n = 31)
10 5 3 3 3 2 1 1 1
15 6 1 2 2 2 1 1 1
Transnasal group
Peroral group
Table 2. Endoscopic findings Hiatal hernia Normal Esophagitis Gastritis Lower esophageal ring Duodenitis Gastric ulcer Barrett’s esophagus Esophageal varices Portal hypertensive gastropathy Paraesophageal hernia
8 11 2 5 3 0 2 1 1 1 0
12 5 8 8 4 4 0 2 0 0 1
in the peroral group (p = 0.03, Student t test). For both groups, multivariate and univariate regression analysis was used to evaluate the effect of preprocedure anxiety, age, and gender on overall patient tolerance and willingness of patients to have subsequent unsedated examinations. Only age in the peroral group had a significant effect on overall patient tolerance (p = 0.02). Older patients, especially those over 40 years of age, tolerated the procedure better than did younger patients. However, age did not affect the willingness of patients in the peroral group to undergo unsedated examinations in the future (p = 0.12). DISCUSSION Patients undergoing routine upper endoscopy for gastrointestinal symptoms were randomized to either a peroral or a transnasal route of insertion in this study, and examinations were performed without sedation. Procedures through the transnasal route were completed in 86% of the patients. Three of the 4 unsuccessful transnasal procedures were due to an inability to pass the instrument beyond the nasal passage. The success rate in our study was similar to that in a study by Rey et al.,7 where unsedated transnasal GASTROINTESTINAL ENDOSCOPY
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Table 3. Patient demographics and general information
Age Gender, male:female Previous EGDs Completed exams Complications Duration of exam
Transnasal group (n = 29)
Peroral group (n = 35) (4 were transnasal crossovers)
p Value
48 15:14 27% 86% (25 of 29) 3% (1 of 29)* 523 seconds (range 180-730)
45 21:14 20% 97% (34 of 35) 0% 410 seconds (range 183-1255)
0.35 0.6 0.55 0.17 0.43 0.03†
*Complication: proximal esophageal perforation. †Statistically significant by Student t test.
Table 4. Endoscopist evaluation* Transnasal group (n = 29) (Mean ± standard error) Ease of insertion Optical quality in esophagus Optical quality in stomach Optical quality in duodenum Patient comfort during insertion Patient comfort during procedure
3.3 1.2 2.1 1.5 2.4 2.4
± ± ± ± ± ±
0.6 0.1 0.3 0.3 0.3 0.5
Peroral group (n = 35) (4 were transnasal crossovers) (Mean ± standard error) 2.2 1.4 2.3 1.5 2.9 2.8
± ± ± ± ± ±
0.2 0.1 0.2 0.1 0.3 0.3
p Value 0.1 0.3 0.57 0.83 0.27 0.51
*Scale 1-10, where “1” is excellent and “10” is poor.
Table 5. Patient evaluation*
Pre-procedure anxiety During insertion Anxiety Pain Gagging Choking During procedure Anxiety Pain Gagging Overall tolerance‡ Willingness for future unsedated endoscopy
Transnasal group (n = 29) (Mean ± standard error)
Peroral group (n = 35) (4 were transnasal crossovers) (Mean ± standard error)
3.0 ± 0.6
3.6 ± 0.5
0.39
4.4 4.4 4.3 3.2
± ± ± ±
0.6 0.6 0.7 0.7
4.7 2.7 5.2 3.2
± ± ± ±
0.5 0.5 0.6 0.6
0.63 0.03† 0.28 0.96
3.3 3.4 3.2 3.8
± ± ± ±
0.7 0.6 0.6 0.7
3.3 2.1 4.7 2.4
± ± ± ±
0.5 0.5 0.5 0.5
0.99 0.11 0.07 0.08
69% (20 of 29)
89% (31 of 35)
p Value
0.07
*Scale 0-10, where “0” is none and “10” is severe. †Statistically significant by Student t test ‡Measured on a 0-10 scale where “0” is good and “10” is poor.
endoscopy in 283 patients was successful in 91.2% of cases. Peroral unsedated endoscopy was successful in 97% of the cases in the current study, which is similar to success rates between 86% and 99% reported in previous studies.2,12 In this study, unsedated endoscopy (both peroral and transnasal combined) was successfully completed in 59 of 60 patients. Furthermore, the only patient in whom unsedated endoscopy failed 282
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required general anesthesia to complete the procedure. It is important to note, however, that enrolled patients in the present study were self-selected because a significant percentage (43%) of those who were asked to participate declined. The endoscopists’ evaluations concerning the optical quality of the ultrathin instrument for both routes of insertion were not significantly different. VOLUME 49, NO. 3, PART 1, 1999
Peroral versus transnasal unsedated endoscopy with ultrathin videoendoscope
Although the ultrathin videoendoscopes (Olympus N200 and N230) used in this study do not match the optical quality of standard videoendoscopes, the accuracy of endoscopy performed with these instruments has been validated by our group.2 In addition, the ease of insertion, as assessed by the endoscopists, was not significantly different between the two routes. However, as reported in previous studies,8,10 the average duration of an examination was significantly longer in the transnasal group. For this study, all participating endoscopists underwent training by otolaryngologists in transnasal insertion so that unfamiliarity with transnasal insertion would not bias the results. In addition, the endoscopists’ perception of patient discomfort between the two routes during insertion and during the remainder of the unsedated examination was not significantly different. However, the endoscopists rated the patient comfort during insertion and during the procedure better numerically for the transnasal group, while the patient rated it worse. This finding is similar to results found in previous studies where endoscopists and patients differed in their assessment of discomfort during unsedated endoscopy.12,13 Pain on insertion was rated as being significantly worse with the transnasal route, and there was a trend toward more gagging with the peroral route. However, overall tolerance was similar in both groups, although better tolerance of the peroral route approached statistical significance. More important, the majority of patients in both groups were willing to undergo unsedated endoscopy in the future. A higher willingness among patients in the peroral group approached statistical significance. These results are similar to those obtained by Craig et al.14 where unsedated transnasal endoscopy was compared with a peroral unsedated endoscopy using an ultrathin endoscope for both routes in patients with upper gastrointestinal symptoms. Several studies of unsedated endoscopy have identified patient characteristics that positively affect patient tolerance, including age over 50, male gender, and a low pre-procedure anxiety level.4,15 These same factors were evaluated in our study, and only age in the peroral group significantly affected tolerance. Older patients, especially those over 40 years of age, had a better tolerance for the unsedated peroral procedure. This did not significantly affect the likelihood of patients in the peroral group being willing to undergo unsedated examinations in the future. Patients must accept unsedated endoscopy if it is to be widely performed in the United States. In the present study, 43% of patients who were approached were unwilling to undergo unsedated endoscopy. The major reasons for this unwillingness included VOLUME 49, NO. 3, PART 1, 1999
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anxiety in 40%, a fear of gagging in 22%, and a reluctance to have transnasal endoscopy in 16%. In addition, many of these patients were expecting sedation when initially approached about the study. Possible ways to improve acceptance include offering patients a choice of which route they prefer (peroral or transnasal) and offering unsedated endoscopy at the time of a clinic visit. Unsedated upper endoscopy using an ultrathin endoscope is successful in the majority of patients with either the peroral or transnasal intubation. In addition, overall tolerance and willingness to undergo unsedated endoscopy in the future was similar between the two routes. The peroral route of insertion may be preferable for the following reasons: the transnasal approach requires special training, causes more discomfort on insertion, takes longer to perform, and some patients are reluctant to accept it. It was disappointing that more than 40% of patients approached for the study refused an unsedated procedure. Further studies need to be done to define ways to improve patient acceptance before unsedated endsocopy can become widely performed in the United States. REFERENCES 1. DeGregorio BT, Poorman JC, Katon RM. Peroral ultrathin endoscopy in adult patients. Gastrointest Endosc 1996; 45:303-6. 2. Zaman A, Hapke R, Sahagun G, Katon RM. Unsedated peroral endoscopy with a new video ultrathin endoscope: patient acceptance, tolerance, and diagnostic accuracy. Am J Gastroenterol 1998;93:1260-3. 3. Al-Atrakchi HA. Upper gastrointestinal endoscopy without sedation: a prospective study of 2000 examinations. Gastrointest Endosc 1989;35:79-81. 4. Tan CC, Freeman JG. Throat spray for upper gastrointestinal endoscopy is quite acceptable to patients. Endoscopy 1996;28:277-82. 5. Mulcahy HE, Alstead EM, McKenzie C, Riches A, Kiely M, Farthing MJG, Fairclough PD. A randomized trial of a 5.5 mm vs 9.5 mm diameter videogastroscope in unsedated upper GI endoscopy [abstract]. Gastrointest Endosc 1997;45:AB54. 6. Shaker R. Unsedated trans-nasal pharyngoesophagogastroduodenoscopy (T-EGD): technique. Gastrointest Endosc 1994;40:346-8. 7. Rey JF, Duforest D, Marek TA. The feasibility of upper GI endoscopy performed through the nose using thin videoendoscope [abstract]. Gastrointest Endosc 1996;43:302. 8. Dean R, Dua K, Massey B, Berger W, Hogan W, Shaker R. A comparative study of unsedated transnasal esophagogastroduodenoscopy and conventional EGD. Gastrointest Endosc 1996;44:422-4. 9. Elfant AB, Scheider DM, Bourke MJ, Alhalel R, Peikin SR, Haber GB, et al. Prospective controlled trial of transnasal endoscopy (T-EGD) vs per-oral endoscopy (P-EGD) [abstract]. Gastrointest Endosc 1996;43:311. 10. Rey JF, Duforest D, Marek TA. Prospective comparison of nasal versus oral insertion of a thin video endoscope in healthy volunteers. Endoscopy 1996;28:422-4. 11. Jensen MP, Karoly P, Braver S. The measurement of clinical GASTROINTESTINAL ENDOSCOPY
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pain intensity: a comparison of six models. Pain 1986;27: 117-26. 12. Thompson DG, Evans SJ, Murray RS, Lennard-Jones JE, Cowan RE, Wright JT. Patients appreciate premedication for endoscopy. Lancet 1980;2:469-70. 13. Beavis AK, LaBrooy S, Misiewicz JJ. Evaluation of one-visit endoscopic clinic for patients with dyspepsia. BMJ 1979; 1:1387-9.
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14. Craig A, Shoeman M, Dent J. A comparison of narrow bore transnasal and transoral endoscopy in usedated patients [abstract]. Gastrointest Endosc 1998;47:AB28. 15. Mulcahy HE, Kelly P, Banks M, Farthing MJG, Fairclough PD, Kumar P. Factors associated with tolerance to unsedated upper gastrointestinal endoscopy [abstract]. Gastrointest Endosc 1998;47:AB56.
VOLUME 49, NO. 3, PART 1, 1999
Background: Potential advantages of unsedated endoscopy include the prevention of side effects or morbidity related to the use of sedative drugs, less intensive patient monitoring, and less expense. We compared transnasal (T-EGD) with peroral (P-EGD) unsedated endoscopy by using an ultrathin video instrument with respect to patient tolerance and acceptance. Method: Patients were randomized to T-EGD or P-EGD. If the initial route of insertion failed, the patient was crossed over to the other route. If this also failed, the patient underwent endoscopy under conscious sedation with an ultrathin instrument. A questionnaire for tolerance was completed by the patient (a validated 0-10 scale where “0” represents none/well tolerated and “10” represents severe/poorly tolerated). Results: Of 105 recruited patients, 60 consented to undergo unsedated endoscopy. There were 20 men and 11 women (mean age 45 years) in the P-EGD group and 15 men and 14 women (mean age 48 years) in the T-EGD group. Of 35 total P-EGD patients (4 were crossed over T-EGD patients), 34 (97%) completed an unsedated examination. Of 29 T-EGD patients, 25 (86%) had a complete examination. Three T-EGD examinations failed for anatomical reasons; all 3 patients when crossed over to the P-EGD route had a successful examination. One patient was unable to tolerate either route. Between the P-EGD and the T-EGD groups, pre-procedure anxiety (3.6 ± 0.5 vs. 3.0 ± 0.6), discomfort during insertion (2.1 ± 0.5 vs. 3.3 ± 0.7), gagging (4.7 ± 0.5 vs. 3.2 ± 0.6), and overall tolerance (2.4 ± 0.5 vs. 3.8 ± 0.7) were similar (p > 0.05). However, discomfort on insertion was significantly greater in the T-EGD versus the P-EGD group (4.4 ± 0.6 vs. 2.7 ± 0.5: p < 0.05). Eighty-nine percent of P-EGD patients and 69% of T-EGD patients, p = 0.07, were willing to undergo unsedated endoscopy in the future. Conclusion: T-EGD patients experienced significantly more pain on insertion than did P-EGD patients. Otherwise, unsedated endoscopy by either the transnasal or the peroral route is generally well tolerated. In this study it was completed in 59 of 60 patients. (Gastrointest Endosc 1999;49:279-84.) Sedation is routinely used in the United States for patients undergoing upper endoscopic procedures. There has been recent interest in unsedated endoscopy, in part as a result of the development of ultrathin (5 to 6 mm in diameter) fiberoptic and Received July 31, 1998. For revision August 20, 1998. Accepted September 24, 1998. From the Department of Medicine, Division of Gastroenterology, Oregon Health Sciences University, Portland, Oregon. Presented as a poster at the annual meeting of the American Society of Gastrointestinal Endoscopy, May 1998, New Orleans, Louisiana. Reprint requests: Ronald M. Katon, MD, Division of Gastroenterology, PV-310, Oregon Health Sciences University, 3181 SW Sam Jackson Park Drive, Portland, OR 97201. Copyright © 1999 by the American Society for Gastrointestinal Endoscopy. 0016-5107/99/$8.00 + 0 37/1/94669 VOLUME 49, NO. 3, PART 1, 1999
video esophagogastroduodenoscopes.1,2 Unsedated upper endoscopy has several advantages over sedated examinations including the prevention of cardiopulmonary complications related to sedation, less intensive patient monitoring, and less expense. In addition, unsedated endoscopy offers advantages to the patient, including the ability to return to work the same day. Several studies conducted outside the United States have shown that peroral unsedated endoscopy, using standard-diameter upper endoscopes, is well tolerated by patients.3,4 However, there has been a reluctance to perform unsedated endoscopy in the United States because of concerns of poor patient tolerance and acceptance. Mulcahy et al.5 have reported preliminary data showing that patients tolerate peroral unsedated endoscopy with an ultrathin (5.9 mm diameter) endoscope better GASTROINTESTINAL ENDOSCOPY
279
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Peroral versus transnasal unsedated endoscopy with ultrathin videoendoscope
than they do with a standard (9.5 mm diameter) upper endoscope. We have shown that unsedated peroral endoscopy using an ultrathin endoscope (N200: Olympus America Inc., Melville, N.Y.) is well tolerated by patients, with 86% completing the examination and with 81% willing to undergo an examination in the future.2 The feasibilty of unsedated transnasal endoscopy in the United States was initially reported by Shaker et al.6 in 1994. Rey et al.7 in a European cohort of 283 patients successfully completed transnasal examinations in 91.2% of patients, with 91.8% of them being willing to undergo subsequent unsedated examinations. Two studies comparing transnasal insertion of an ultrathin endoscope with peroral intubation with a standard endoscope have shown that the transnasal route for unsedated upper endoscopy causes less gagging and is better tolerated overall than the peroral route.8,9 However, few studies of unsedated endoscopy have compared the transnasal and the peroral routes using an ultrathin endoscope for both routes. Rey et al. used 10 healthy volunteers to compare tolerance for transnasal and peroral routes of insertion.10 They noted that patients had significantly more pain on insertion with the transnasal route and significantly more gagging with the peroral route and that patients did not prefer one route over the other. This is the first randomized study in the United States comparing unsedated transnasal and peroral endosocopy using an ultrathin endoscope for both routes. The following parameters were assessed: patient acceptance, patient tolerance, and patient characteristics affecting tolerance. PATIENTS AND METHODS Outpatients were recruited from our hospital’s gastroenterology clinics and the endoscopy unit over a 12month period. All study candidates were being evaluated for upper GI symptoms. Patients were excluded if there was evidence of an acute gastrointestinal hemorrhage, a history of sinus surgery or recurrent sinusitis, any current anticoagulation therapy, dysphagia possibly requiring esophageal dilation, a need for sclerotherapy or band ligation of varices, or surveillance for Barrett’s esophagus. The study was approved by the Institutional Review Board of our university. The Olympus N200 and N230 ultrathin endoscopes (Olympus America Inc., Melville, N.Y.; N200 is the original name, and the later model is designated N230) have an outer diameter of 6 mm, an accessory channel diameter of 2 mm, a total length of 1,245 mm, and a working length of 925 mm. They are forward-viewing instruments, with a 120-degree field. Tip deflection is 180 degrees up and down and 160 degrees left to right. They have an ultraminiature, high-resolution charged-coupled device (CCD) 280
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that generates a black and white image that is converted into color. The ultrathin instruments do not require special cleaning techniques or equipment for disinfection. No mechanical dysfunction was encountered with these instruments during the study period. Endoscopy was performed by either experienced endoscopists or by supervised senior gastroenterology fellows. All endoscopists participating in the study were trained in the transnasal approach by otolaryngologists at our hospital. The otolaryngologists also determined competence of each endoscopist in the transnasal approach. After informed consent was obtained from each patient, unsedated endoscopy was performed with the Olympus N200 or N230. Before the procedure patients assessed their anxiety level on a 0-10 scale where “0” represented no anxiety and “10” represented severe anxiety. Patients randomized to the peroral group received a pharyngeal spray with 20% benzocaine (Beutlich L.P. Pharmaceuticals, Waukegan, Ill.). Patients randomized to the transnasal group received a nasal spray composed of a 1% phenylephrine/4% lidocaine solution. Blood pressure, pulse, cardiac rhythm, and oxygen saturation were monitored and recorded every 5 minutes. After the unsedated examination, patients were asked to complete a questionnaire regarding their tolerance of the procedure in terms of discomfort during insertion and during the remainder of the procedure, as well as their overall tolerance of the procedure. A validated 0-10 pain scale (where “0” was none and “10” was severe) was used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure.11 Overall tolerance was rated on a scale from 0-10, where “0” was good and “10” was poor tolerance. In addition, patients were asked if they would choose to have unsedated endoscopy again (yes/no). The endoscopist then completed a questionnaire assessing the optical quality of the instrument (in the esophagus, the stomach, and the duodenum) and patient tolerance on a 1-10 scale (where “1” is excellent and “10” is poor). The endoscopist considered the examination complete if he or she was able to adequately inspect the upper GI tract. Statistical analysis comparing the transnasal and peroral routes included the Student t test and the Fisher exact test. Univariate and multivariate regression analysis was used for both groups to assess factors (age, gender, and pre-procedure anxiety) affecting patient tolerance and willingness to undergo unsedated examinations in the future.
RESULTS A total of 105 consecutive outpatients undergoing upper endoscopy because of GI symptoms were asked to participate in this study. This number did not reflect all patients undergoing upper endoscopies during the study period, because potential candidates were approached only if the ultrathin instrument and an endoscopist involved in the study were available. Forty-five patients refused to participate in the study. Reasons given included anxiety (n = 18), a fear of gagging (n = 10), not being interested in the study (n = 10), and not wishing to VOLUME 49, NO. 3, PART 1, 1999
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undergo a transnasal procedure (n = 7). The mean age of the patients willing to participate was 46 years (range 21 to 84 years). There were 35 men and 25 women. Initially, 29 patients were randomized into the transnasal group and 31 patients into the peroral group. Indications and endoscopic findings are described in Tables 1 and 2. There were no significant differences between the indications for the two groups. Four of the 29 patients in the transnasal group required crossover to the peroral group. Three patients were crossed over because the ultrathin instrument could not be passed beyond the nasal passage; peroral unsedated endoscopy was successful in all three. The fourth patient, a 25-year-old woman undergoing screening endoscopy for esophageal varices, was crossed over into the peroral group because she could not tolerate the transnasal procedure. This patient also could not tolerate an unsedated or a sedated peroral examination and eventually required endoscopy under general anesthesia. No patient in the peroral group required crossover into the transnasal group. Table 3 shows patient demographics and general examination information for both groups. There were no significant differences in demographics. The duration of the examination was significantly longer in the transnasal group, compared with the peroral group (p = 0.03, Student t test). The duodenum was reached, when attempted (2 patients were undergoing endoscopy for follow-up of gastric ulcers, and it was not necessary to visualize the duodenum), in all patients who successfully completed an unsedated examination. One complication occurred in the transnasal group: A 56-year-old woman undergoing unsedated endoscopy for abdominal pain and early satiety became intolerant, with severe gagging, during the procedure after an easy transnasal intubation. The procedure was terminated, and she was discharged home after an uneventful post-procedure period of observation. Several hours after her discharge, facial swelling developed, and eventually a small proximal esophageal perforation was diagnosed by means of an x-ray swallowing series using water-soluable contrast. Surgical exploration of the neck did not reveal a perforation. She recovered fully from this complication. Table 4 shows data on the endoscopists’ evaluation of the ease of insertion of the instrument, the optical quality of the instrument, and the patients’ tolerance. No significant difference was found between either group. Table 5 shows data on the patients’ own evaluations of the procedure. The only significant difference in this area between the two groups was that patients in the transnasal group had significantly more pain on insertion than those VOLUME 49, NO. 3, PART 1, 1999
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Table 1. Indications for upper endoscopy Transnasal group (n = 29) GERD Dyspepsia Rule out Barrett’s esophagus Abdominal pain Rule out varices Nausea/vomiting Follow-up gastric ulcer Anemia Diarrhea
Peroral group (n = 31)
10 5 3 3 3 2 1 1 1
15 6 1 2 2 2 1 1 1
Transnasal group
Peroral group
Table 2. Endoscopic findings Hiatal hernia Normal Esophagitis Gastritis Lower esophageal ring Duodenitis Gastric ulcer Barrett’s esophagus Esophageal varices Portal hypertensive gastropathy Paraesophageal hernia
8 11 2 5 3 0 2 1 1 1 0
12 5 8 8 4 4 0 2 0 0 1
in the peroral group (p = 0.03, Student t test). For both groups, multivariate and univariate regression analysis was used to evaluate the effect of preprocedure anxiety, age, and gender on overall patient tolerance and willingness of patients to have subsequent unsedated examinations. Only age in the peroral group had a significant effect on overall patient tolerance (p = 0.02). Older patients, especially those over 40 years of age, tolerated the procedure better than did younger patients. However, age did not affect the willingness of patients in the peroral group to undergo unsedated examinations in the future (p = 0.12). DISCUSSION Patients undergoing routine upper endoscopy for gastrointestinal symptoms were randomized to either a peroral or a transnasal route of insertion in this study, and examinations were performed without sedation. Procedures through the transnasal route were completed in 86% of the patients. Three of the 4 unsuccessful transnasal procedures were due to an inability to pass the instrument beyond the nasal passage. The success rate in our study was similar to that in a study by Rey et al.,7 where unsedated transnasal GASTROINTESTINAL ENDOSCOPY
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Table 3. Patient demographics and general information
Age Gender, male:female Previous EGDs Completed exams Complications Duration of exam
Transnasal group (n = 29)
Peroral group (n = 35) (4 were transnasal crossovers)
p Value
48 15:14 27% 86% (25 of 29) 3% (1 of 29)* 523 seconds (range 180-730)
45 21:14 20% 97% (34 of 35) 0% 410 seconds (range 183-1255)
0.35 0.6 0.55 0.17 0.43 0.03†
*Complication: proximal esophageal perforation. †Statistically significant by Student t test.
Table 4. Endoscopist evaluation* Transnasal group (n = 29) (Mean ± standard error) Ease of insertion Optical quality in esophagus Optical quality in stomach Optical quality in duodenum Patient comfort during insertion Patient comfort during procedure
3.3 1.2 2.1 1.5 2.4 2.4
± ± ± ± ± ±
0.6 0.1 0.3 0.3 0.3 0.5
Peroral group (n = 35) (4 were transnasal crossovers) (Mean ± standard error) 2.2 1.4 2.3 1.5 2.9 2.8
± ± ± ± ± ±
0.2 0.1 0.2 0.1 0.3 0.3
p Value 0.1 0.3 0.57 0.83 0.27 0.51
*Scale 1-10, where “1” is excellent and “10” is poor.
Table 5. Patient evaluation*
Pre-procedure anxiety During insertion Anxiety Pain Gagging Choking During procedure Anxiety Pain Gagging Overall tolerance‡ Willingness for future unsedated endoscopy
Transnasal group (n = 29) (Mean ± standard error)
Peroral group (n = 35) (4 were transnasal crossovers) (Mean ± standard error)
3.0 ± 0.6
3.6 ± 0.5
0.39
4.4 4.4 4.3 3.2
± ± ± ±
0.6 0.6 0.7 0.7
4.7 2.7 5.2 3.2
± ± ± ±
0.5 0.5 0.6 0.6
0.63 0.03† 0.28 0.96
3.3 3.4 3.2 3.8
± ± ± ±
0.7 0.6 0.6 0.7
3.3 2.1 4.7 2.4
± ± ± ±
0.5 0.5 0.5 0.5
0.99 0.11 0.07 0.08
69% (20 of 29)
89% (31 of 35)
p Value
0.07
*Scale 0-10, where “0” is none and “10” is severe. †Statistically significant by Student t test ‡Measured on a 0-10 scale where “0” is good and “10” is poor.
endoscopy in 283 patients was successful in 91.2% of cases. Peroral unsedated endoscopy was successful in 97% of the cases in the current study, which is similar to success rates between 86% and 99% reported in previous studies.2,12 In this study, unsedated endoscopy (both peroral and transnasal combined) was successfully completed in 59 of 60 patients. Furthermore, the only patient in whom unsedated endoscopy failed 282
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required general anesthesia to complete the procedure. It is important to note, however, that enrolled patients in the present study were self-selected because a significant percentage (43%) of those who were asked to participate declined. The endoscopists’ evaluations concerning the optical quality of the ultrathin instrument for both routes of insertion were not significantly different. VOLUME 49, NO. 3, PART 1, 1999
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Although the ultrathin videoendoscopes (Olympus N200 and N230) used in this study do not match the optical quality of standard videoendoscopes, the accuracy of endoscopy performed with these instruments has been validated by our group.2 In addition, the ease of insertion, as assessed by the endoscopists, was not significantly different between the two routes. However, as reported in previous studies,8,10 the average duration of an examination was significantly longer in the transnasal group. For this study, all participating endoscopists underwent training by otolaryngologists in transnasal insertion so that unfamiliarity with transnasal insertion would not bias the results. In addition, the endoscopists’ perception of patient discomfort between the two routes during insertion and during the remainder of the unsedated examination was not significantly different. However, the endoscopists rated the patient comfort during insertion and during the procedure better numerically for the transnasal group, while the patient rated it worse. This finding is similar to results found in previous studies where endoscopists and patients differed in their assessment of discomfort during unsedated endoscopy.12,13 Pain on insertion was rated as being significantly worse with the transnasal route, and there was a trend toward more gagging with the peroral route. However, overall tolerance was similar in both groups, although better tolerance of the peroral route approached statistical significance. More important, the majority of patients in both groups were willing to undergo unsedated endoscopy in the future. A higher willingness among patients in the peroral group approached statistical significance. These results are similar to those obtained by Craig et al.14 where unsedated transnasal endoscopy was compared with a peroral unsedated endoscopy using an ultrathin endoscope for both routes in patients with upper gastrointestinal symptoms. Several studies of unsedated endoscopy have identified patient characteristics that positively affect patient tolerance, including age over 50, male gender, and a low pre-procedure anxiety level.4,15 These same factors were evaluated in our study, and only age in the peroral group significantly affected tolerance. Older patients, especially those over 40 years of age, had a better tolerance for the unsedated peroral procedure. This did not significantly affect the likelihood of patients in the peroral group being willing to undergo unsedated examinations in the future. Patients must accept unsedated endoscopy if it is to be widely performed in the United States. In the present study, 43% of patients who were approached were unwilling to undergo unsedated endoscopy. The major reasons for this unwillingness included VOLUME 49, NO. 3, PART 1, 1999
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anxiety in 40%, a fear of gagging in 22%, and a reluctance to have transnasal endoscopy in 16%. In addition, many of these patients were expecting sedation when initially approached about the study. Possible ways to improve acceptance include offering patients a choice of which route they prefer (peroral or transnasal) and offering unsedated endoscopy at the time of a clinic visit. Unsedated upper endoscopy using an ultrathin endoscope is successful in the majority of patients with either the peroral or transnasal intubation. In addition, overall tolerance and willingness to undergo unsedated endoscopy in the future was similar between the two routes. The peroral route of insertion may be preferable for the following reasons: the transnasal approach requires special training, causes more discomfort on insertion, takes longer to perform, and some patients are reluctant to accept it. It was disappointing that more than 40% of patients approached for the study refused an unsedated procedure. Further studies need to be done to define ways to improve patient acceptance before unsedated endsocopy can become widely performed in the United States. REFERENCES 1. DeGregorio BT, Poorman JC, Katon RM. Peroral ultrathin endoscopy in adult patients. Gastrointest Endosc 1996; 45:303-6. 2. Zaman A, Hapke R, Sahagun G, Katon RM. Unsedated peroral endoscopy with a new video ultrathin endoscope: patient acceptance, tolerance, and diagnostic accuracy. Am J Gastroenterol 1998;93:1260-3. 3. Al-Atrakchi HA. Upper gastrointestinal endoscopy without sedation: a prospective study of 2000 examinations. Gastrointest Endosc 1989;35:79-81. 4. Tan CC, Freeman JG. Throat spray for upper gastrointestinal endoscopy is quite acceptable to patients. Endoscopy 1996;28:277-82. 5. Mulcahy HE, Alstead EM, McKenzie C, Riches A, Kiely M, Farthing MJG, Fairclough PD. A randomized trial of a 5.5 mm vs 9.5 mm diameter videogastroscope in unsedated upper GI endoscopy [abstract]. Gastrointest Endosc 1997;45:AB54. 6. Shaker R. Unsedated trans-nasal pharyngoesophagogastroduodenoscopy (T-EGD): technique. Gastrointest Endosc 1994;40:346-8. 7. Rey JF, Duforest D, Marek TA. The feasibility of upper GI endoscopy performed through the nose using thin videoendoscope [abstract]. Gastrointest Endosc 1996;43:302. 8. Dean R, Dua K, Massey B, Berger W, Hogan W, Shaker R. A comparative study of unsedated transnasal esophagogastroduodenoscopy and conventional EGD. Gastrointest Endosc 1996;44:422-4. 9. Elfant AB, Scheider DM, Bourke MJ, Alhalel R, Peikin SR, Haber GB, et al. Prospective controlled trial of transnasal endoscopy (T-EGD) vs per-oral endoscopy (P-EGD) [abstract]. Gastrointest Endosc 1996;43:311. 10. Rey JF, Duforest D, Marek TA. Prospective comparison of nasal versus oral insertion of a thin video endoscope in healthy volunteers. Endoscopy 1996;28:422-4. 11. Jensen MP, Karoly P, Braver S. The measurement of clinical GASTROINTESTINAL ENDOSCOPY
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pain intensity: a comparison of six models. Pain 1986;27: 117-26. 12. Thompson DG, Evans SJ, Murray RS, Lennard-Jones JE, Cowan RE, Wright JT. Patients appreciate premedication for endoscopy. Lancet 1980;2:469-70. 13. Beavis AK, LaBrooy S, Misiewicz JJ. Evaluation of one-visit endoscopic clinic for patients with dyspepsia. BMJ 1979; 1:1387-9.
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14. Craig A, Shoeman M, Dent J. A comparison of narrow bore transnasal and transoral endoscopy in usedated patients [abstract]. Gastrointest Endosc 1998;47:AB28. 15. Mulcahy HE, Kelly P, Banks M, Farthing MJG, Fairclough PD, Kumar P. Factors associated with tolerance to unsedated upper gastrointestinal endoscopy [abstract]. Gastrointest Endosc 1998;47:AB56.
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