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Evaluation of reusable devices for ERCP: Infectious safety and durability
*3285 EVALUATION OF REUSABLE DEVICES F O R ERCP: INFECTIOUS sAFETY AND DURABILITY Frederic P. Prat, Jacques Fritsch, Coralie Pallier, CHU Bic tre, Le Kremlin Bicetre France; Andre Daniel Choury, Gilles Pelletier, Pierre Nordmann, Catherine Buffet, CHU Bic tre, Le Kremlin Bicetre France Opting for reusable or single use devices depends on various and contradictory medical and economic criteria. We wanted to evaluate 2 criteria for reusable devices used for daily therapeutic ERCP: the durability, represented by the number of possible uses under satisfactory technical conditions, and the risk of transmission of infectious agents between patients. All the patients referred for endsocopic sphincterotomy with or without stone extraction could be included. 3 types of instruments were studied: a standard sphincterotome (KD-5q), a guided sphincterotome (KD6G12q), and a dormia basket (FG22q), all from Olympus corp (Tokyo, Japan). The instruments were autoclaved at 134°C during 18mn after ultrasonic exposure. Before each use, the instruments were flushed with saline for bacteriological (6 different media) and virological tests (HCV-PCR and HBV markers); HCB and HBV serologies were also tested. The instruments were examined before and after each procedure and kept for reuse or discarded depending on predefined criteria. The main judgement criterion of the study was the median number of possible uses per type of instrument. 230 patients were included; the procedure was a sphincterotomy for stone extraction or ampulloma or sphincter of Oddi dysfunction (172 patients), stenting (35 patients), instrumental exploration of the common bile duct with a dormia basket without sphincterotomy (7 patients), diagnostic ERCP or failure of biliary caunulation (16 patients). At the time of ERCP, 7 patients had uncontrolled septicemia, 6 had a positive serum HCV test, 1 a positive serum HBV test and 2 had a positive HIV test. 35 instruments have been used (10 standard sphincterotomes, 10 guided sphincterotomes and 15 dormia baskets). The median number of efficient uses per instrument was 15 for the standard sphincterotome, 7 for the guided sphincterotome and 12 for the dormia basket (3/15 baskets had been destroyed for mechanical lithotripsy). Virological tests of all instruments were negative, as well as all bacteriological tests (apart for 12 cases of contamination by coagulase- staphylococci of dermic origin). The analysis of costs per instrument and per patient, without prejudice of detailed cost analysis, suggests that reusable devices are cost-effective when compared to single -use devices. We conclude that the reusable instruments evaluated in this study are safe for infectious hazards with respect to the infectious agents tested; they are able to endure numerous re-uses, which makes reusable instruments cost-effective.
*3286 META-ANALYSIS OF RANDOMIZED CONTR O LLED TR IA LS COMPARING COLONOSCOPY P R E P A R A T I O N WITH ORAL SOIDIUM PHOSPHATE (NAP) AND POLYETHYLENE GLYCOL ELECTROLYTE LAVAGE SOLUTION (PEG-ELS) Howard Y. Chang, Colin W. Howden, Northwestern Univ, Chicago, IL Patients preparing for colonoscopy often report difficulty in consuming the large volume of fluid necessary with PEG-ELS. Oral NaP represents an alternative means of preparation for colonoscopy that requires a smaller fluid volume. Randomized controlled trials (RCTs) have compared these two forms of preparation, but have reported conflicting results. Aim: To compare the effectiveness and tolerability of these two forms of colonoscopy preparation by meta-analysis of RCTs. Methods: We conducted a fully recursive literature search for RCTs that compared NaP and PEG-ELS for colonoscopy preparation. Homogeneity among RCTs was assessed by the Breslew-Day test. Outcomes studied were endoscopists' blinded assessments of quality of preparation and patients' subjective assessments of the tolerability of the preparations. Trial results were pooled and the absolute benefit increase (ABI) and number needed to treat (NNT) were calculated for NaP over PEG-ELS. Pooled Mantel-Haenszel odds ratios (ORr,i.H) were calculated for quality of preparation and patient tolerability. Results: 11 RCTs reported endoscopists' blinded assessments of quality of preparation. There was a significant degree of heterogeneity among RCTs (P=0.0001). 861 patients were randomized to NaP; 1128 to PEG-ELS. Preparation rates were rated "good" or "excellent" in 82.3% and 74.9% of patients, respectively (ABI = 7.4%; NNT = 13.5). ORM.H was 1.78 (95% CI = 1.41 to
VOLUME 53, NO. 5, 2001
2.25). 6 RCTs reported patients' overall assessments of ease of taking the preparation. There was a significant degree of heterogeneity among them (P = 0.0134). 431 patients had been randomized to NaP; 420 to PEG-ELS. The preparations were rated as tolerable by, respectively, 84.5% and 67.6% of patients (ABI = 16.8%; NNT = 5.9). ORM.H was 2.76 (95% CI = 1.96 to 3.87). Conclusions: Despite considerable heterogeneity among the RCTs, oral NaP was associated with improved preparation quality and higher patient tolerability than PEG-ELS. Preparing around 13 patients for colonescepy with NaP rather than PEG-ELS should result in one more good or excellent quality preparation. It would take around 6 patients being prepared with NaP rather than PEG-ELS to result in one more patient experiencing an easy preparation. Oral NaP can, therefore, be recommended for preparing patients for colonoscopy, particularly if they are concerned about consuming a large volume of liquid, as with PEG-ELS.
*3287 ENDOSCOPIC MUCOSAL RESECTION ASSOCIATED COMPLICATIONS. TOWARDS SAFER EMR. Kiranpreet S. Parmar, Yajaira Sierra, Angela Reeves, Irving Waxman, Univ of Texas Medical Branch, Galveston, TX Background: Endoscopic mucosal resection (EMR) has become a widely used medality for the treatment of epithelial and submucosal lesions (SMT). The complications include bleeding and perforation. Our aim was to analyze all complications recorded during our 5 year EMR experience, to determine their cause, and, hence, lead to a safer method of performing this technique. Methods: The records of 68 patients diagnosed with superficial epithelial or SMT lesions referred to our department for EMR were reviewed. The layer of origin and location of SMT was determined by high frequency ultrasound probe sonography (HFUPS). The strip biopsy or suction cap technique was employed. EMR was performed after submucosal saline injection of up to 15 ml. Results: There were 61 (90%) EMR s performed from a total of 68 patients. Thirty-three (49%) out of the 68 lesions were mucosal, 28 (41%) were submucosal, 3 (4%) were from the muscularis mucosa, and 2 (3%) were from the muscularis propria. Fifty-nine (97%) lesions were completely resected and the margins were clear. In one patient, the mucosal rectal lesion had lateral adenomatous margins and, in another submucosal rectal lesion, the EMR specimen showed a carcinoid with positive margins. A total of five (8%) complications were reported, two major (3%) and three minor (5%). The major complications included one perforation (1.6%) while removing a duodenal villous adenoma and one bleed (esophagus) requiring transfusion (1.6 %); both were secondary to a low amount of submucosal injection. The minor complications were two transmural burns (rectal) (3%), and one pancreatitis (1.6%) secondary to removal of an ampullary mass. The complication rate was no different when looking at the layer of origin, organ, learning curve (early vs. late), type of lesion (histology), or EMR technique.Conclusion: HFUPS-assisted EMR is a safe and effective technique for selected patients with early mucosal or SMT lesions of the GI tract. In our experience, insufficient volume of submucosal saline injection (less than 5 ml) is the only factor associated with major complications (bleeding, perforation).
Complication
Layer of Origin
Organ
Experience: Eady (96-98) Late (98-00)
Technique: Life and Cut vs. Cap
Minor (3)
Mucosal
Lift and Cut
Mucosal
Ampulla Rectum (2) Esophagus. Duodenum
Early, 3
Major (2)
Lale, 2
Lift and Cut
GASTROINTESTINAL ENDOSCOPY
AB75
*3286 META-ANALYSIS OF RANDOMIZED CONTR O LLED TR IA LS COMPARING COLONOSCOPY P R E P A R A T I O N WITH ORAL SOIDIUM PHOSPHATE (NAP) AND POLYETHYLENE GLYCOL ELECTROLYTE LAVAGE SOLUTION (PEG-ELS) Howard Y. Chang, Colin W. Howden, Northwestern Univ, Chicago, IL Patients preparing for colonoscopy often report difficulty in consuming the large volume of fluid necessary with PEG-ELS. Oral NaP represents an alternative means of preparation for colonoscopy that requires a smaller fluid volume. Randomized controlled trials (RCTs) have compared these two forms of preparation, but have reported conflicting results. Aim: To compare the effectiveness and tolerability of these two forms of colonoscopy preparation by meta-analysis of RCTs. Methods: We conducted a fully recursive literature search for RCTs that compared NaP and PEG-ELS for colonoscopy preparation. Homogeneity among RCTs was assessed by the Breslew-Day test. Outcomes studied were endoscopists' blinded assessments of quality of preparation and patients' subjective assessments of the tolerability of the preparations. Trial results were pooled and the absolute benefit increase (ABI) and number needed to treat (NNT) were calculated for NaP over PEG-ELS. Pooled Mantel-Haenszel odds ratios (ORr,i.H) were calculated for quality of preparation and patient tolerability. Results: 11 RCTs reported endoscopists' blinded assessments of quality of preparation. There was a significant degree of heterogeneity among RCTs (P=0.0001). 861 patients were randomized to NaP; 1128 to PEG-ELS. Preparation rates were rated "good" or "excellent" in 82.3% and 74.9% of patients, respectively (ABI = 7.4%; NNT = 13.5). ORM.H was 1.78 (95% CI = 1.41 to
VOLUME 53, NO. 5, 2001
2.25). 6 RCTs reported patients' overall assessments of ease of taking the preparation. There was a significant degree of heterogeneity among them (P = 0.0134). 431 patients had been randomized to NaP; 420 to PEG-ELS. The preparations were rated as tolerable by, respectively, 84.5% and 67.6% of patients (ABI = 16.8%; NNT = 5.9). ORM.H was 2.76 (95% CI = 1.96 to 3.87). Conclusions: Despite considerable heterogeneity among the RCTs, oral NaP was associated with improved preparation quality and higher patient tolerability than PEG-ELS. Preparing around 13 patients for colonescepy with NaP rather than PEG-ELS should result in one more good or excellent quality preparation. It would take around 6 patients being prepared with NaP rather than PEG-ELS to result in one more patient experiencing an easy preparation. Oral NaP can, therefore, be recommended for preparing patients for colonoscopy, particularly if they are concerned about consuming a large volume of liquid, as with PEG-ELS.
*3287 ENDOSCOPIC MUCOSAL RESECTION ASSOCIATED COMPLICATIONS. TOWARDS SAFER EMR. Kiranpreet S. Parmar, Yajaira Sierra, Angela Reeves, Irving Waxman, Univ of Texas Medical Branch, Galveston, TX Background: Endoscopic mucosal resection (EMR) has become a widely used medality for the treatment of epithelial and submucosal lesions (SMT). The complications include bleeding and perforation. Our aim was to analyze all complications recorded during our 5 year EMR experience, to determine their cause, and, hence, lead to a safer method of performing this technique. Methods: The records of 68 patients diagnosed with superficial epithelial or SMT lesions referred to our department for EMR were reviewed. The layer of origin and location of SMT was determined by high frequency ultrasound probe sonography (HFUPS). The strip biopsy or suction cap technique was employed. EMR was performed after submucosal saline injection of up to 15 ml. Results: There were 61 (90%) EMR s performed from a total of 68 patients. Thirty-three (49%) out of the 68 lesions were mucosal, 28 (41%) were submucosal, 3 (4%) were from the muscularis mucosa, and 2 (3%) were from the muscularis propria. Fifty-nine (97%) lesions were completely resected and the margins were clear. In one patient, the mucosal rectal lesion had lateral adenomatous margins and, in another submucosal rectal lesion, the EMR specimen showed a carcinoid with positive margins. A total of five (8%) complications were reported, two major (3%) and three minor (5%). The major complications included one perforation (1.6%) while removing a duodenal villous adenoma and one bleed (esophagus) requiring transfusion (1.6 %); both were secondary to a low amount of submucosal injection. The minor complications were two transmural burns (rectal) (3%), and one pancreatitis (1.6%) secondary to removal of an ampullary mass. The complication rate was no different when looking at the layer of origin, organ, learning curve (early vs. late), type of lesion (histology), or EMR technique.Conclusion: HFUPS-assisted EMR is a safe and effective technique for selected patients with early mucosal or SMT lesions of the GI tract. In our experience, insufficient volume of submucosal saline injection (less than 5 ml) is the only factor associated with major complications (bleeding, perforation).
Complication
Layer of Origin
Organ
Experience: Eady (96-98) Late (98-00)
Technique: Life and Cut vs. Cap
Minor (3)
Mucosal
Lift and Cut
Mucosal
Ampulla Rectum (2) Esophagus. Duodenum
Early, 3
Major (2)
Lale, 2
Lift and Cut
GASTROINTESTINAL ENDOSCOPY
AB75