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Uncovered metal stents for management of inoperable malignant colorectal strictures
Abstracts PA.257 PALLIATION OF MALIGNANT BILIARY OBSTRUCTION WITH POLYURETHANE-COVERED SELF-EXPANDING METALSTENT D. Giordani *, N. Ierfone, A. Sedici
Ospedale SS Filippo e Nicola, Aveu:ano Background and aim: Endoscopic stent insertion has become widely accepted as a standard treatment for the palliation of malignant biliary obstruction and it has been showed to have lower morbidity and mortality than biliary bypass surgery. Various studies have been showed that uncovered self-expandable metal stents (SEMSs) remain patent longer compared with plastic stents. However, premature occlusion due to tumor ingrowth limits the efficacy of treatment and represents a leading cause for reintervention. Aim of this study was to investigate the efficacy and safety of the covered Wallstent in the management of unresectable malignant biliary obstruction. Material and methods: Thirty-four patients (22 men, 12 women; age: 76± 10 years, mean±SD) with unresectable malignant biliary obstruction presenting with obstructive jaundice were consecutively enrolled from October 2001 to June 2004. All patients were treated by endoscopic insertion of a covered SEMSs (Wallstent, Microvasive Endoscopy, Boston Scientific Corp., Natick, Mass.). The stent patency, complications and patient survival were evaluated. Results: Covered Wallstents were successfully placed in all patients. Early complications related to stent insertion included mild post-ERCP pancreatitis (1 patient) that was successfully managed with conservative therapy. The serum bilirubin failed to decrease after stent placement in 2 patients with liver failure those subsequently died at 15 and 16 days after stent placement, respectively. There was no death as a direct consequence of stent insertion. All patients had died by the end of the study. Median survival was 188 days (range 15-873). Stent occlusion or migration were not observed during the study. Conclusions: The results of our study suggest that covered Wallstent may be effective in preventing tumor ingrowth and may therefore reduce the rate of stent occlusion in patients with unresectable malignant biliary obstruction.
PA.258 COMPLICATION AFTER ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) OF BENIGN PERI-RECTAL LESION G. Mezzi *, PG. Arcidiacono, S. Carrara, C. Boemo, C. Doglioni, PA. Testoni
Ospedale San Raffaele, Milan Background and aim: Tailgut cysts are rare congenital abnormalities in the retrorectal and presacral region, that can present with different clinical symptoms or complications; rarely undergo malignant transformation. We report a case of a complication after EUS-FNA. A 50 years old woman was referred to our unit to underwent an EUS-FNA for a lesion in the rectum; she complained constipation and digital rectal examination revealed a submucosal mass (2 em) on rectum posterior region. Radial EUS shows an isoechoic lesion, with well-defined margins, oval and bilobate (25 x 14 mm) in the upper portion. No lymph nodes in peri-rectal fat. No lesions on pelvic MRI imaging. Informed and written consent was obtained. EUS with linear probe (pentax 3830UI) confirmed the lesion; no other alterations or lymph nodes were observed. Medical treatment before the procedure: intravenous prophylaxis with antibiotics (ampicillin 2 gr, gentamicine 80 mg) and conscious sedation with midazolam 2 mg intravenous. EUS-FNA was performed using an EchoTip ultrasound needle (25G Wilson-Cook Medical Inc.). The aspirate was placed on glass slides and reviewed on site by a cytopathologist to ensure the adequacy of the specimens.
S147
No immediate complications were encountered. Cytological diagnosis: numerous scaly cells without atypical findings and rare stromal cells; no malignant cells. Five day after the procedure, patient was referring pain in the posterior region of rectum, fever, lumboischial pain and and spontaneous cutaneous drainage. On EUS the lesion appears changed, hypoecoic, with no-well-defined margins compatible with pelvic abscess or hematic extravasation after EUS-FNA. Patient was hospitalised for clinical rivalutation. MRI imaging shows, in the presacral-coccyx region, an abscess surrounded from granulation tissues. The patient has been discharged in tenth day by the hospital in good clinical conditions, with disappeared of the referred symptoms. Surgical treatment has not been necessary. The risk of bacteremia after EUS-FNA is low. The cysts located in the retrorectal and presacral region can become infected easily but this, to our notice, must not exclude a certain diagnosis. The complication observed after the procedure could be limited by antibiotic administering in the next days, even if in literature have not been published data on the usefulness pharmacological prophylactics.
PA.259 NARROW BAND IMAGING FOR DETECTION AND SURVEILLANCE OF BARRETT'S ESOPHAGUS: PRELIMINARY RESULTS PG. Lecca *, A. Larghi, M.E. Riccioni, A. Bizzotto, G. Costamagna
UO di Endoscopia Digestiva Chirurgica, Policlinico "A. Gemelli ", Roma Background and aim: The identification of Barrett's Esophagus (BE) may be difficult in some patients. Moreover, in patients with known BE the diagnostic yield of random biopsies according to the Seattle protocol in diagnosing dysplasia or EC is unsatisfactory. We studied the value of Narrow Band Imaging (NB!), which is able to increase mucosal pit pattern and vascular abnormalities recognition potentially helping directing targeted biopsies, in patients with suspected or known BE under surveillance. Material and methods: Eleven patients (MIF: 912; mean age 57.7 yrs; range 32-82) with suspected BE (2) and with BE under surveillance (9) underwent upper GI endoscopy with an NBI gastroscope (OLYMPUS XGIF-H160Y2) which was performed by an experienced endoscopist. NBI-guided biopsies were taken and the relationship between NBI findings and histological diagnosis was assessed. Results: In one patient, NBI showed a regular mucosal pattern and normal blood vessels' size, shape and distribution consistent with the absence of BE which was confirmed at the histology. In 7 patients NBI evidenced a mild irregular mucosal pit pattern with slightly dilated and tortuous blood vessels. In these cases histology showed low-grade dysplasia in 4 and BE without dysplasia in 3. In the remaining 3 patients, NBI evidenced abnormally dilated and tortuous blood vessels with an extremely irregular mucosal pattern. These findings consistent with a more advanced pathological abnormality were confirmed at biopsy which showed high-grade dysplasia (2) and EC (1). Conclusions: NBI images appear to be consistent with histological results and may be a useful clinical tool for directing biopsies to detect BE or dysplasiaJEC without chromoendoscopy.
PA.260 UNCOVERED METAL STENTS FOR MANAGEMENT OF INOPERABLE MALIGNANT COLORECTAL STRICTURES
1. Stroppa *, C. Tosti, F. Andrei, R. Lionetti, E. Grasso, F. Pallone Tor Vergata University, Rome Background and aim: Self-expanding metal stents (SEMSs) are endoscopically used in colorectal strictures since early '90s, for the management of colorectal obstruction as an alternative to surgery. Aim
S148
Abstracts
of the study was to review feasibility and efficacy of SEMSs in a retrospective series of colorectal strictures. Material and methods: From September 2004 to October 2005, 12 patients (7 men and 5 women, mean age 72 years, range 60-91) underwent the insertion of a SEMS for an obstruction lesion in the left-sided colon or rectum. The site of the cancer was the rectosigmoid colon in 2 patients, the sigmoid colon in 7 and the left-sided colon in 3. The stent was advanced over gnidewire nnder flnoroscopic control withont previons dilatation. A gnidewire was inserted through the strictnre using ultrathin endoscope (Olympus GlF XP160) in 8 patients. In 4 patients with complete bowel obstruction Gastrografin was injected in the ERCP catheter to determine the length and morphology of the stricture. Subsequently, a guidewire was inserted throngh the ERCP catheter and advanced across the obstrnction. The Ultraflex Precision SEMS was nsed in 11 cases (proximal release), whereas the Wallstent Unistep prosthesis in 1 case. All patients were clinically evaluated and underwent endoscopic follow-up as occlusive symptoms relapsed. Results: Metal stents were always placed successfully relieving the obstrnction. Total hospital stay was 72 hours. There were no serious complications related to the procednre. In one patient, early distal migration occnrred (Wallstent Unistep prosthesis), with fnrther treatment with a second stent. Median follow-up for all patients was 11 months: two patients died after 30 and 75 days respectively since the endoscopic treatment, due to progression ofthe underlying neoplastic process; eigth patients were still alive at the end of the follow- up period and all had good luminal patency, whereas two symptomatic patients underwent an endoscopic examination showing no evidence of intestinal obstruction. Conclusions: SEMSs are safe and effective as a palliative treatment in patients with inoperable malignant colorectal strictures and provide a better quality of life compared to surgical colostomy. On the other hand, costs analysis is needed in order to assess SEMSs cost-effectiveness.
PA.261 OBSCURE·OCCULT BLEEDING: A COMPARISON OF VIDEOCAPSULE ENDOSOCPY AND ENTERO CT IN 50 CONSECUTIVE PATIENTS A. Milano' 1 , C. Balatsinon 1, F. Laterza 1, A. Filippone 2 , N. Genovesi 2, M.P. Caldarella 1, F. Sacco 1, F. Cuccurnllo 1, M. Neri .,1
lDepartment ofMedicine and Ageing Sciences, Section ofInternal Medicine and Gastroenterology and the Centre ofExcellences for the study ofAgeing (Ce.s.I.), "G. D'Annunzio" University and Foundation, Chieti 2 Department of Clincal Sciences and Bioim£lges, Section of Radiological Sciences "G.D'Annunzio" University, Chieti
Background and aim: Obscure-Occult bleeding, that is endoscopynegative patients with chronic iron deficiency anemia andl or positive fecal occult blood test is a difficult diagnostic challenge. Up to now, radiologic techniqnes are considered the gold standard for small bowel stndy, among which entero-CT is considered the most sensitive method to investigate intestinal wall lesions. Video Capsule Endoscopy (VCE; M2A Given), a novel, non invasive device has proven effective in suspected small bowel lesions. The aim of ours study was to evaluate the role of VCE in a selected group of patients with gastrointestinal occnlt bleeding in comparison to entero-CT. Material and methods: Consecutive patients with obscure-occnlt bleeding were evaluated. All nnderwent EGD and colonoscopy plus ileoscopy. If negative, patients were blindly evaluated by entero-CT and VCE. Statistical analysis was performed by McNemar test. Results: 50 patients were evaluated in our unit (mean age 61 yrs, 31 male, 19 female). All reported recent negative endoscopy at other institntions. At repeated endoscopy a source of bleeding was identified in 13 ont of 50 (25%). In endoscopy-negative patients (n = 37,26 male, 11 female; mean age 59 yrs) an entero-CT and VCE were performed. VCE
allowed a diagnoses in 27/37 patients (73%; aterovenous malformation 29,7%, neoplasia 10.8%, inflammatory bowel diseases 16.2%, polyps 5.4%, celiac disease 5.4%, active bleeding withont seeing a bleeding source) versus 10/37 patients at entero-CT (inflammatory bowel diseases 8.1%, neoplasia 10.8%, polyps 5.4%, submucosal lesion 2.7%); (VCE vsentero-CT: p < 0.001). All but one entero-CT-positive patients were also positive to VCE. Conclusions: VCE improves the diagnostic gain in patients with obscure-occult bleeding. X-ray techniqnes shonld be limited to the exclusion of small bowel strictures prior to VCE or used to further study patients with occult bleeding after inconclusive VCE examination.
PA.262 TRANSNASAL GASTROSCOPY WITHOUT SEDATION VERSUS TRANSORAL GASTROSCOPY UNDER SEDATION: A RANDOMISED PROSPECTIVE STUDY ON ACCURACY, ACCEPTABILITY, FEASIBILITY AND SAFETY I. Stroppa', C. Tosti, C. Razzini, S. Mazzocchi, E. Grasso, O.A. Paolnzi, L. Biancone, F. Pallone
Tor Vergata University, Rome
Background and aim: Conscious sedation is not rarely required during transoral gastroscopy (TO). Transnasal gastroscopy (TN) has proven to be less invasive than TO, suggesting feasibility with no sedation. Aim of the study was to evaluate diagnostic accnracy, acceptability, feasibility and safety of TN withont sedation compared with TO nnder sedation in a series of pts nndergoing gastroscopy. Material and methods: Thirty pts (16 men, mean age 48.47 ± 13.37 years) candidate to upper GI endoscopy were randomised to undergo TN and TO, in two consecutive days, by two different gastroenterologists. Pts nnderwent TO nnder conscious sedation (Lv. midazolam) and TN nnder local anaesthesia (lydocaine). Before endoscopy, all pts were assessed for anxiety by using Hamilton A scale. Diagnostic accuracy was judged comparing endoscopic findings by TN and TO. In order to assess the concordance of endoscopic patterns (inter-observer) a third endoscopist reviewed tape recording of both examinations. Reliable histology of gastric biopsy specimens collected during both TN and TO was also considered. Acceptability was stated on the basis of discomfort at insertion and during endoscopy and preference among TN or TO. Endoscopists and nnrses also gave their opinion on feasibility of TN and TO. Safety of TN and TO was judged comparing cardio-respiratory parameters (oxygen saturation, one-lead ECG, blood pressure) monitored during endoscopy. Results: All pts underwent both TN and TO, bnt one who did not tolerate TO and reqnired to stop examination. All TN and TO were performed till second portion of duodennm and showed similar findings, the concordance among endoscopic patterns being complete. All biopsy specimens were adequate for histological assessment. Anxiety was absent in 18 pts, mild in 9, moderate in 1 and requiring treatment in 2. Mean scores of discomfort were similar in both gronps, bnt 26/30 pts (87%) preferred TN. Of 12 pts with anxiety, only 2 preferred TO with sedation. Feasibility was good both for TN and TO. No severe cardiac or respiratory adverse event occurred during TN and TO. Conclusions: The present study demonstrates that TN without sedation is well tolerated and better accepted than TO under sedation. High level of diagnostic accnracy and safety suggest that TN shonld be taken into account as a valid alternative to TO in routine diagnostic gastroscopy.
Ospedale SS Filippo e Nicola, Aveu:ano Background and aim: Endoscopic stent insertion has become widely accepted as a standard treatment for the palliation of malignant biliary obstruction and it has been showed to have lower morbidity and mortality than biliary bypass surgery. Various studies have been showed that uncovered self-expandable metal stents (SEMSs) remain patent longer compared with plastic stents. However, premature occlusion due to tumor ingrowth limits the efficacy of treatment and represents a leading cause for reintervention. Aim of this study was to investigate the efficacy and safety of the covered Wallstent in the management of unresectable malignant biliary obstruction. Material and methods: Thirty-four patients (22 men, 12 women; age: 76± 10 years, mean±SD) with unresectable malignant biliary obstruction presenting with obstructive jaundice were consecutively enrolled from October 2001 to June 2004. All patients were treated by endoscopic insertion of a covered SEMSs (Wallstent, Microvasive Endoscopy, Boston Scientific Corp., Natick, Mass.). The stent patency, complications and patient survival were evaluated. Results: Covered Wallstents were successfully placed in all patients. Early complications related to stent insertion included mild post-ERCP pancreatitis (1 patient) that was successfully managed with conservative therapy. The serum bilirubin failed to decrease after stent placement in 2 patients with liver failure those subsequently died at 15 and 16 days after stent placement, respectively. There was no death as a direct consequence of stent insertion. All patients had died by the end of the study. Median survival was 188 days (range 15-873). Stent occlusion or migration were not observed during the study. Conclusions: The results of our study suggest that covered Wallstent may be effective in preventing tumor ingrowth and may therefore reduce the rate of stent occlusion in patients with unresectable malignant biliary obstruction.
PA.258 COMPLICATION AFTER ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) OF BENIGN PERI-RECTAL LESION G. Mezzi *, PG. Arcidiacono, S. Carrara, C. Boemo, C. Doglioni, PA. Testoni
Ospedale San Raffaele, Milan Background and aim: Tailgut cysts are rare congenital abnormalities in the retrorectal and presacral region, that can present with different clinical symptoms or complications; rarely undergo malignant transformation. We report a case of a complication after EUS-FNA. A 50 years old woman was referred to our unit to underwent an EUS-FNA for a lesion in the rectum; she complained constipation and digital rectal examination revealed a submucosal mass (2 em) on rectum posterior region. Radial EUS shows an isoechoic lesion, with well-defined margins, oval and bilobate (25 x 14 mm) in the upper portion. No lymph nodes in peri-rectal fat. No lesions on pelvic MRI imaging. Informed and written consent was obtained. EUS with linear probe (pentax 3830UI) confirmed the lesion; no other alterations or lymph nodes were observed. Medical treatment before the procedure: intravenous prophylaxis with antibiotics (ampicillin 2 gr, gentamicine 80 mg) and conscious sedation with midazolam 2 mg intravenous. EUS-FNA was performed using an EchoTip ultrasound needle (25G Wilson-Cook Medical Inc.). The aspirate was placed on glass slides and reviewed on site by a cytopathologist to ensure the adequacy of the specimens.
S147
No immediate complications were encountered. Cytological diagnosis: numerous scaly cells without atypical findings and rare stromal cells; no malignant cells. Five day after the procedure, patient was referring pain in the posterior region of rectum, fever, lumboischial pain and and spontaneous cutaneous drainage. On EUS the lesion appears changed, hypoecoic, with no-well-defined margins compatible with pelvic abscess or hematic extravasation after EUS-FNA. Patient was hospitalised for clinical rivalutation. MRI imaging shows, in the presacral-coccyx region, an abscess surrounded from granulation tissues. The patient has been discharged in tenth day by the hospital in good clinical conditions, with disappeared of the referred symptoms. Surgical treatment has not been necessary. The risk of bacteremia after EUS-FNA is low. The cysts located in the retrorectal and presacral region can become infected easily but this, to our notice, must not exclude a certain diagnosis. The complication observed after the procedure could be limited by antibiotic administering in the next days, even if in literature have not been published data on the usefulness pharmacological prophylactics.
PA.259 NARROW BAND IMAGING FOR DETECTION AND SURVEILLANCE OF BARRETT'S ESOPHAGUS: PRELIMINARY RESULTS PG. Lecca *, A. Larghi, M.E. Riccioni, A. Bizzotto, G. Costamagna
UO di Endoscopia Digestiva Chirurgica, Policlinico "A. Gemelli ", Roma Background and aim: The identification of Barrett's Esophagus (BE) may be difficult in some patients. Moreover, in patients with known BE the diagnostic yield of random biopsies according to the Seattle protocol in diagnosing dysplasia or EC is unsatisfactory. We studied the value of Narrow Band Imaging (NB!), which is able to increase mucosal pit pattern and vascular abnormalities recognition potentially helping directing targeted biopsies, in patients with suspected or known BE under surveillance. Material and methods: Eleven patients (MIF: 912; mean age 57.7 yrs; range 32-82) with suspected BE (2) and with BE under surveillance (9) underwent upper GI endoscopy with an NBI gastroscope (OLYMPUS XGIF-H160Y2) which was performed by an experienced endoscopist. NBI-guided biopsies were taken and the relationship between NBI findings and histological diagnosis was assessed. Results: In one patient, NBI showed a regular mucosal pattern and normal blood vessels' size, shape and distribution consistent with the absence of BE which was confirmed at the histology. In 7 patients NBI evidenced a mild irregular mucosal pit pattern with slightly dilated and tortuous blood vessels. In these cases histology showed low-grade dysplasia in 4 and BE without dysplasia in 3. In the remaining 3 patients, NBI evidenced abnormally dilated and tortuous blood vessels with an extremely irregular mucosal pattern. These findings consistent with a more advanced pathological abnormality were confirmed at biopsy which showed high-grade dysplasia (2) and EC (1). Conclusions: NBI images appear to be consistent with histological results and may be a useful clinical tool for directing biopsies to detect BE or dysplasiaJEC without chromoendoscopy.
PA.260 UNCOVERED METAL STENTS FOR MANAGEMENT OF INOPERABLE MALIGNANT COLORECTAL STRICTURES
1. Stroppa *, C. Tosti, F. Andrei, R. Lionetti, E. Grasso, F. Pallone Tor Vergata University, Rome Background and aim: Self-expanding metal stents (SEMSs) are endoscopically used in colorectal strictures since early '90s, for the management of colorectal obstruction as an alternative to surgery. Aim
S148
Abstracts
of the study was to review feasibility and efficacy of SEMSs in a retrospective series of colorectal strictures. Material and methods: From September 2004 to October 2005, 12 patients (7 men and 5 women, mean age 72 years, range 60-91) underwent the insertion of a SEMS for an obstruction lesion in the left-sided colon or rectum. The site of the cancer was the rectosigmoid colon in 2 patients, the sigmoid colon in 7 and the left-sided colon in 3. The stent was advanced over gnidewire nnder flnoroscopic control withont previons dilatation. A gnidewire was inserted through the strictnre using ultrathin endoscope (Olympus GlF XP160) in 8 patients. In 4 patients with complete bowel obstruction Gastrografin was injected in the ERCP catheter to determine the length and morphology of the stricture. Subsequently, a guidewire was inserted throngh the ERCP catheter and advanced across the obstrnction. The Ultraflex Precision SEMS was nsed in 11 cases (proximal release), whereas the Wallstent Unistep prosthesis in 1 case. All patients were clinically evaluated and underwent endoscopic follow-up as occlusive symptoms relapsed. Results: Metal stents were always placed successfully relieving the obstrnction. Total hospital stay was 72 hours. There were no serious complications related to the procednre. In one patient, early distal migration occnrred (Wallstent Unistep prosthesis), with fnrther treatment with a second stent. Median follow-up for all patients was 11 months: two patients died after 30 and 75 days respectively since the endoscopic treatment, due to progression ofthe underlying neoplastic process; eigth patients were still alive at the end of the follow- up period and all had good luminal patency, whereas two symptomatic patients underwent an endoscopic examination showing no evidence of intestinal obstruction. Conclusions: SEMSs are safe and effective as a palliative treatment in patients with inoperable malignant colorectal strictures and provide a better quality of life compared to surgical colostomy. On the other hand, costs analysis is needed in order to assess SEMSs cost-effectiveness.
PA.261 OBSCURE·OCCULT BLEEDING: A COMPARISON OF VIDEOCAPSULE ENDOSOCPY AND ENTERO CT IN 50 CONSECUTIVE PATIENTS A. Milano' 1 , C. Balatsinon 1, F. Laterza 1, A. Filippone 2 , N. Genovesi 2, M.P. Caldarella 1, F. Sacco 1, F. Cuccurnllo 1, M. Neri .,1
lDepartment ofMedicine and Ageing Sciences, Section ofInternal Medicine and Gastroenterology and the Centre ofExcellences for the study ofAgeing (Ce.s.I.), "G. D'Annunzio" University and Foundation, Chieti 2 Department of Clincal Sciences and Bioim£lges, Section of Radiological Sciences "G.D'Annunzio" University, Chieti
Background and aim: Obscure-Occult bleeding, that is endoscopynegative patients with chronic iron deficiency anemia andl or positive fecal occult blood test is a difficult diagnostic challenge. Up to now, radiologic techniqnes are considered the gold standard for small bowel stndy, among which entero-CT is considered the most sensitive method to investigate intestinal wall lesions. Video Capsule Endoscopy (VCE; M2A Given), a novel, non invasive device has proven effective in suspected small bowel lesions. The aim of ours study was to evaluate the role of VCE in a selected group of patients with gastrointestinal occnlt bleeding in comparison to entero-CT. Material and methods: Consecutive patients with obscure-occnlt bleeding were evaluated. All nnderwent EGD and colonoscopy plus ileoscopy. If negative, patients were blindly evaluated by entero-CT and VCE. Statistical analysis was performed by McNemar test. Results: 50 patients were evaluated in our unit (mean age 61 yrs, 31 male, 19 female). All reported recent negative endoscopy at other institntions. At repeated endoscopy a source of bleeding was identified in 13 ont of 50 (25%). In endoscopy-negative patients (n = 37,26 male, 11 female; mean age 59 yrs) an entero-CT and VCE were performed. VCE
allowed a diagnoses in 27/37 patients (73%; aterovenous malformation 29,7%, neoplasia 10.8%, inflammatory bowel diseases 16.2%, polyps 5.4%, celiac disease 5.4%, active bleeding withont seeing a bleeding source) versus 10/37 patients at entero-CT (inflammatory bowel diseases 8.1%, neoplasia 10.8%, polyps 5.4%, submucosal lesion 2.7%); (VCE vsentero-CT: p < 0.001). All but one entero-CT-positive patients were also positive to VCE. Conclusions: VCE improves the diagnostic gain in patients with obscure-occult bleeding. X-ray techniqnes shonld be limited to the exclusion of small bowel strictures prior to VCE or used to further study patients with occult bleeding after inconclusive VCE examination.
PA.262 TRANSNASAL GASTROSCOPY WITHOUT SEDATION VERSUS TRANSORAL GASTROSCOPY UNDER SEDATION: A RANDOMISED PROSPECTIVE STUDY ON ACCURACY, ACCEPTABILITY, FEASIBILITY AND SAFETY I. Stroppa', C. Tosti, C. Razzini, S. Mazzocchi, E. Grasso, O.A. Paolnzi, L. Biancone, F. Pallone
Tor Vergata University, Rome
Background and aim: Conscious sedation is not rarely required during transoral gastroscopy (TO). Transnasal gastroscopy (TN) has proven to be less invasive than TO, suggesting feasibility with no sedation. Aim of the study was to evaluate diagnostic accnracy, acceptability, feasibility and safety of TN withont sedation compared with TO nnder sedation in a series of pts nndergoing gastroscopy. Material and methods: Thirty pts (16 men, mean age 48.47 ± 13.37 years) candidate to upper GI endoscopy were randomised to undergo TN and TO, in two consecutive days, by two different gastroenterologists. Pts nnderwent TO nnder conscious sedation (Lv. midazolam) and TN nnder local anaesthesia (lydocaine). Before endoscopy, all pts were assessed for anxiety by using Hamilton A scale. Diagnostic accuracy was judged comparing endoscopic findings by TN and TO. In order to assess the concordance of endoscopic patterns (inter-observer) a third endoscopist reviewed tape recording of both examinations. Reliable histology of gastric biopsy specimens collected during both TN and TO was also considered. Acceptability was stated on the basis of discomfort at insertion and during endoscopy and preference among TN or TO. Endoscopists and nnrses also gave their opinion on feasibility of TN and TO. Safety of TN and TO was judged comparing cardio-respiratory parameters (oxygen saturation, one-lead ECG, blood pressure) monitored during endoscopy. Results: All pts underwent both TN and TO, bnt one who did not tolerate TO and reqnired to stop examination. All TN and TO were performed till second portion of duodennm and showed similar findings, the concordance among endoscopic patterns being complete. All biopsy specimens were adequate for histological assessment. Anxiety was absent in 18 pts, mild in 9, moderate in 1 and requiring treatment in 2. Mean scores of discomfort were similar in both gronps, bnt 26/30 pts (87%) preferred TN. Of 12 pts with anxiety, only 2 preferred TO with sedation. Feasibility was good both for TN and TO. No severe cardiac or respiratory adverse event occurred during TN and TO. Conclusions: The present study demonstrates that TN without sedation is well tolerated and better accepted than TO under sedation. High level of diagnostic accnracy and safety suggest that TN shonld be taken into account as a valid alternative to TO in routine diagnostic gastroscopy.