One-step versus two-step procedure for management procedures for management of concurrent gallbladder and common bile duct stones. Outcomes and cost analysis.

BACKGROUND: The management of cholelithiasis and choledocholithiasis combined is controversial. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. This study aims to demonstrate how, on the basis of the personal experience, the Rendez-vous technique, that combines the two techniques in a single-stage operation is better than the sequential treatment. METHODS: Between June 2017 to December 2019, 40 consecutive patients with cholelithiasis and choledocholithiasis combined were enrolled for the study: 20 were treated with the sequential treatment and 20 with the Rendez-vous method. The preoperative diagnostic work-up was similar in the two group. The endpoints of the study included incidence of endoscopic and surgical complications, rate of hospitalization and cost analysis. RESULTS: The study showed no difference in demographic parameters between the two groups, but the success rate of clearance of CBD was significantly smaller for sequential arm, with the need of additional procedures. We found a statistical reduction of postoperative acute pancreatitis, hospital stay and charges in Rendez-vous group, at the expense of a prolonged total operating time. CONCLUSIONS: The data of the study confirm the superiority of the Rendez-vous technique because it resolves cholelithiasis associated with choledocholithiasis in a single surgical act, with greater acceptance of the patient who avoids a second invasive surgical act, and with a reduction in complications; moreover, it requires shorter hospitalization, resulting in reduced costs. We propose this option in the management of cases where preoperative ERCP-ES has failed. KEY WORDS: Common bile duct stones, Cholecysto-choledocholithiasis, Endoscopic retrograde cholangiopancreatography, Endoscopic sphincterotomy, Laparoscopic cholecystectomy, Laparo-endoscopic Rendez-vous.

Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study.

Background and study aims Endoscopic sphincterotomy plus large-balloon dilation (ES-LBD) has been reported as an alternative to endoscopic sphincterotomy for the removal of bile duct stones. This multicenter study compared complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones. This is the first randomized multicenter study to evaluate these procedures in patients with exclusively large common bile duct (CBD) stones. Methods Between 2010 and 2015, 150 patients with one or more common bile duct stones ≥ 13 mm were randomized to two groups: 73 without balloon dilation (conventional group), 77 with balloon dilation (ES-LBD group). Mechanical lithotripsy was subsequently performed only if the stones were too large for removal through the papilla. Endoscopic sphincterotomy was complete in both groups. Patients could switch to ES-LBD if the conventional procedure failed. Results There was no between-group difference in number and size of stones. CBD stone clearance was achieved in 74.0 % of patients in the conventional group and 96.1 % of patients in the ES-LBD group (P < 0.001). Mechanical lithotripsy was needed significantly more often in the conventional group (35.6 % vs. 3.9 %; P < 0.001). There was no difference in terms of morbidity (9.3 % in the conventional group vs. 8.1 % in the ES-LBD group; P = 0.82). The cost and procedure time were not significantly different between the groups overall, but became significantly higher for patients in the conventional group who underwent mechanical lithotripsy. The conventional procedure failed in 19 patients, 15 of whom underwent a rescue ES-LBD procedure that successfully cleared all stones. Conclusions Complete endoscopic sphincterotomy with large-balloon dilation for the removal of large CBD stones has similar safety but superior efficiency to conventional treatment, and should be considered as the first-line step in the treatment of large bile duct stones and in rescue treatment.Trial registered at ClinicalTrials.gov (NCT02592811).

Which is the better treatment for the removal of large biliary stones? Endoscopic papillary large balloon dilation versus endoscopic sphincterotomy.

BACKGROUND/AIMS: We evaluated the efficacy and cost-effectiveness of endoscopic papillary large balloon dilation (EPLBD) for large common bile duct (CBD) stone removal compared with endoscopic sphincterotomy (EST). METHODS: A total of 1,580 patients who underwent endoscopic CBD stone extraction between January 2001 and July 2010 were reviewed. The following inclusion criteria were applied: choledocholithiasis treated by EPLBD with minor EST or EST with mechanical lithotripsy; and follow-up >9 months after treatment. RESULTS: Forty-nine patients with EPLBD and 41 with EST were compared. There was no significant difference in the complication rates and stone recurrence rates between the two groups. However, significantly more endoscopic retrograde cholangiopancreatography (ERCP) sessions were required in the EST group to achieve the complete removal of stones (1.7 times vs 1.3 times; p=0.03). The mean cost required for complete stone removal per patient was significantly higher in the EST group compared to the EPLBD group (USD $1,644 vs $1,225, respectively; p=0.04). Dilated CBD was the only significant factor associated with recurrent biliary stones (relative risk, 1.09; 95% confidence interval, 1.02 to 1.17; p=0.02). CONCLUSIONS: EPLBD is the better treatment (compared to EST) for removing large CBD stones because EPLBD requires fewer ERCP sessions and is less expensive.

Rendezvous technique for cholecystocholedochal lithiasis in octogenarians: is it as effective as in younger patients, or should endoscopic sphincterotomy followed by laparoscopic cholecystectomy be preferred?

BACKGROUND: The treatment of cholecystocholedochal lithiasis (CCL) requires cholecystectomy and common bile duct (CBD) clearance, which can be achieved surgically or with a combination of surgery and endoscopy. The latter includes a two-stage-approach-preoperative retrograde cholangiography (ERC) and sphincterotomy (ST) followed by delayed laparoscopic cholecystectomy (LC), or vice versa-or a one-stage-approach-the rendezvous technique (RVT), where ERC, ST, and LC are performed during the same procedure. No data on the use of RVT in octogenarians have been reported in the literature so far. The study aims to show whether the RVT is as effective in elderly as in younger patients. Moreover, results of RVT are compared with those of a two-stage sequential treatment (TSST) in octogenarians, to identify the best approach to such a population. SUBJECTS AND METHODS: Prospectively collected data of 131 consecutive patients undergoing RVT for biliary tract stone disease were retrospectively analyzed. Two analyses were performed: (1) results of RVT (operative time, conversion rate, CBD clearance, morbidity/mortality, hospital stay, costs, and need for further endoscopy) were compared between octogenarians and younger patients, and (2) results of RVT in the elderly were compared with those of 27 octogenarians undergoing TSST for CCL. RESULTS: Octogenarians undergoing RVT were in poorer general condition (P<.0001) and had a higher conversion rate (P<.0001) and a longer hospital stay (P<.007) than younger patients. No differences in the rates of CBD clearance, surgery-related morbidity, mortality, and costs were recorded. Although octogenarians undergoing RVT were in poorer general condition than those undergoing TSST, the results of the two approaches were similar. CONCLUSIONS: RVT in the elderly seems to be as cost-effective as in younger patients; nevertheless, it may lead to a higher conversion rate and longer hospital stay. In octogenarians, RVT is not inferior to TSST in the treatment of CCL even for patients in poor condition.

Randomized trial of endoscopic sphincterotomy with balloon dilation versus endoscopic sphincterotomy alone for removal of bile duct stones.

BACKGROUND & AIMS: Limited endoscopic sphincterotomy with large balloon dilation (ESBD) is an alternative to endoscopic sphincterotomy (ES) for removing bile duct stones, but it is not clear which procedure is most effective. We compared the 2 techniques in removal of bile duct stones. METHODS: Between September 2005 and September 2011, 156 consecutive patients with suspected of having, or known to have, common bile duct stones were randomly assigned to groups that underwent ES or ESBD. Patients in the ESBD group underwent limited sphincterotomy (up to half of the sphincter) followed by balloon dilation to the size of the common bile duct or 15 mm, and patients in the ES group underwent complete sphincterotomy alone. Stones were then removed using standard techniques. The primary outcome was percentage of stones cleared, and secondary outcomes included procedural time, method of stone extraction, number of procedures required for stone clearance, morbidities and mortality within 30 days, and direct cost. RESULTS: There was no significant difference between groups in percentage of stones cleared (ES vs ESBD: 88.5% vs 89.0%). More patients in the ES group (46.2%) than the ESBD group (28.8%) required mechanical lithotripsy (P = .028), particularly for stones ≥15 mm (90.9% vs 58.1%; P = .002). Morbidities developed in 10.3% of patients in the ES group and 6.8% of patients in the ESBD group (P = .46). The cost of the hospitalization was also significantly lower in the ESBD group (P = .034). CONCLUSIONS: ESBD and ES clear bile stones with equal efficacy. However, ESBD reduces the need for mechanical lithotripsy and is less expensive; ClinicalTrials.gov number, NCT00164853.

Intra-operative vs pre-operative endoscopic sphincterotomy in patients with gallbladder and common bile duct stones: cost-utility and value-of-information analysis.

BACKGROUND: Patients with gallbladder and common bile duct stones are generally treated by pre-operative endoscopic sphincterotomy (ES) followed by laparoscopic cholecystectomy (POES). Recently, a meta-analysis has shown that intra-operative ES during laparoscopic cholecystectomy (IOES) results in fewer complications than POES, with similar efficacy. The cost effectiveness of IOES versus POES is unknown. OBJECTIVE: The objective of this study was to compare the cost effectiveness of IOES versus POES from the UK NHS perspective. METHODS: A decision-tree model estimating and comparing costs to the UK NHS and QALYs gained following a policy of either IOES or POES was developed with a time horizon of 3 years. Uncertainty was investigated with probabilistic sensitivity analysis, and the expected value of perfect information (EVPI) and partial information (EVPPI) were also calculated. RESULTS: IOES was less costly than POES (approximately -£623 per patient [year 2008 values]) and resulted in similar quality of life (+0.008 QALYs per patient) as POES. Given a willingness-to-pay threshold of £20 000 per QALY gained, there was a 92.9% probability that IOES is cost effective compared with POES. Full implementation of IOES could save the NHS £2.8 million per annum. At a willingness to pay of £20 000 per QALY gained, the 10-year population EVPI was estimated at £0.6 million. CONCLUSIONS: IOES appears to be cost effective compared with POES.

Systematic review and meta-analysis of intraoperative versus preoperative endoscopic sphincterotomy in patients with gallbladder and suspected common bile duct stones.

BACKGROUND: Most patients with gallbladder and common bile duct stones are treated by preoperative endoscopic sphincterotomy (POES) followed by laparoscopic cholecystectomy. Recently, intraoperative endoscopic sphincterotomy (IOES) during laparoscopic cholecystectomy has been suggested as an alternative treatment. METHODS: Data from randomized clinical trials related to safety and effectiveness of IOES versus POES were extracted by two independent reviewers. Risk ratios (RRs) or mean differences were calculated with 95 per cent confidence intervals based on intention-to-treat analysis whenever possible. RESULTS: Four trials with 532 patients comparing IOES with POES were included. There were no deaths. There was no significant difference in rates of ampullary cannulation (RR 1·01, 0·97 to 1·04; P = 0·70) or stone clearance by ES (RR 0·99, 0·96 to 1·02; P = 0·58) between the groups. The proportion of patients with at least one post-ES complication, including pancreatitis, bleeding, perforation, cholangitis, cholecystitis or gastric ulcer, was significantly lower in the IOES group (RR 0·37, 0·18 to 0·78; P = 0·009). There was no significant difference in morbidity after laparoscopic cholecystectomy or requirement for open operation between the groups. Mean hospital stay was 3 days shorter in the IOES group: mean difference - 2·83 (-3·66 to - 2·00) days (P < 0·001). CONCLUSION: In patients with gallbladder and common bile duct stones, IOES is as effective and safe as POES and results in a significantly shorter hospital stay.

Hospital cost categories of one-stage versus two-stage management of common bile duct stones.

BACKGROUND: In the era of cost-conscious healthcare, hospitals are focusing on costs. Analysis of hospital costs per cost category may provide indications for potential cost-saving measures in the management of common bile duct stones (CBDS) with gallbladder in situ. METHODS: Between October 2005 and September 2006, 53 consecutive patients suffering from CBDS underwent either a one-stage procedure [laparoscopic common bile duct exploration (LCBDE) with stone clearance and cholecystectomy (LCCE)] or a two-stage procedure [endoscopic retrograde cholangiopancreatography with sphincterotomy and stone clearance (ERCP/ERS) followed by LCCE]. Costs were defined in different cost categories for each activity centre and were linked to the individual patient via the "bill of activities". Only patients (n = 38) with an uneventful post-procedural course and with available cost data were considered for cost analysis. Total length of hospital stay (LOS) was 2 (0-6) days after one-stage and 8 (3-18) days after two-stage procedure (p < 0.0001). RESULTS: Costs per patient were significantly (p < 0.0001) less after one-stage versus two-stage management, i.e. total hospital costs (euro2,636 versus euro4,608), hospitalisation costs (euro701 versus euro2,190), consumables/pharmacy (euro645 versus euro1,476) and para-medical personnel (euro1,035 versus euro1,860; p = 0.0002). Operation room (OR) costs were comparable for one-stage and two-stage management (euro1,278 versus euro1,232; p = 0.280). Total hospital costs during ERCP were euro2,648 (euro729-4,544), during LCCE without LCBDE were euro2,101 (euro1,033-4,269), and during LCCE with LCBDE were euro2,636 (euro1,176-4,235). CONCLUSION: In the management of patients with CBDS and gallbladder in situ a one-stage procedure is associated with significantly less costs as compared with a two-stage procedure. From the economical point of view these patients should preferably be treated via a one-stage procedure as long as safety and efficacy of this approach are provided.

Preoperative endoscopic sphincterotomy versus laparoendoscopic rendezvous in patients with gallbladder and bile duct stones.

OBJECTIVE: To compare success rate, length of hospital stay, clinical results, and costs of sequential treatment (endoscopic retrograde cholangiopancreatography followed by laparoscopic cholecystectomy) versus the laparoendoscopic Rendezvous in patients with cholecysto-choledocholithiasis. BACKGROUND: The ideal management of common bile duct (CBD) stones in the era of laparoscopic cholecystectomy (LC) remains controversial. METHODS: A total of 91 elective patients with cholelithiasis and CBD stones diagnosed at magnetic resonance cholangiography (MRC) were included in a prospective, randomized trial. The patients were randomized in 2 groups. Group I patients (45 cases) underwent a preoperative endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (ES) followed by LC in the same hospital admission. Group II patients (46 cases) underwent LC associated with intraoperative ERCP and ES according to the rendezvous technique. RESULTS: The rate of CBD clearance was 80% for Group I and 95.6% for Group II (P = 0.06). The morbidity rate was 8.8% in Group I and 6.5% in Group II (P = not significant). No deaths occurred in either group. Hospital stay was shorter in Group II than in Group I: 4.3 days versus 8.0 days (P < 0.0001). There was a significant reduction in mean total cost for group II patients versus group I patients: 2829 euro versus 3834 euro (P < 0.05). CONCLUSIONS: When compared with preoperative ERCP with ES followed by LC, the laparoendoscopic rendezvous technique allows a higher rate of CBD stones clearance, a shorter hospital stay, and a reduction in costs.

Suspected sphincter of Oddi dysfunction type II: empirical biliary sphincterotomy or manometry-guided therapy?

BACKGROUND AND STUDY AIMS: Sphincter of Oddi manometry is considered to be the gold standard for diagnosing sphincter of Oddi dysfunction (SOD). Elevated basal sphincter pressures are found in about half of the patients with findings consistent with biliary type II SOD, and most of these patients will symptomatically improve after endoscopic sphincterotomy. Since manometric sphincter evaluation is not widely available, a decision analysis was used to compare the overall costs and outcomes of manometry-directed therapy with "empirical" sphincterotomy in patients with suspected biliary type II SOD. PATIENTS AND METHODS: A decision analysis model was constructed using a software program. In a hypothetical cohort of 100 patients with suspected type II SOD, the following strategies were evaluated: a). endoscopic retrograde cholangiopancreatography (ERCP) with manometry followed by biliary sphincterotomy only if an elevated sphincter of Oddi basal pressure was found; and b). "empirical" biliary sphincterotomy without manometry. Data on the probability of an elevated sphincter of Oddi basal pressure at the time of ERCP in patients with suspected biliary SOD type II, the proportion of patients who improved after biliary sphincterotomy (with and without elevated basal pressures), the proportion of patients who improved without biliary sphincterotomy, complications, and death were obtained from the literature and from our center. The procedural and hospitalization costs represented the average Medicare reimbursement at our institution. The expected overall costs and numbers of patients improving with each strategy were compared.[nl] RESULTS: The strategy of ERCP with manometry resulted in total costs of US dollars 2790 per patient, whereas a strategy of "empirical" biliary sphincterotomy resulted in total costs of US dollars 2244. In a cohort of 100 patients with suspected SOD, 55 % of patients would be expected to improve if manometry were performed, compared to 60 % of patients improving with "empirical" biliary sphincterotomy. Univariate sensitivity analyses demonstrated that "empirical" biliary sphincterotomy continued to be a cost-saving strategy in comparison with ERCP with manometry as long as the probability of spontaneous improvement in patients with "normal" manometry was less than 41 %, the probability of complications associated with manometry was greater than 6 %, and the probability of complications due to biliary sphincterotomy was less than 19 %. CONCLUSIONS: For patients with suspected biliary SOD type II, empirical biliary sphincterotomy performed by experienced endoscopists appears to be cost-saving in comparison with a strategy based on the results of manometry.

[Endoscopic sphincterotomy as an out-patient procedure: is it safe?]. / Esfinterotomía endoscópica (EE) como procedimiento ambulatorio: es seguro?

BACKGROUND: Patients have been routinely admitted for observation for potential complications after therapeutic ERCP; however, in this era of cost containment it may be more cost-effective to perform these procedures on an out-patient basis. AIM: The purpose of this study was to determine safety and complication rates of endoscopic sphincterotomy in out-patients. MATERIALS AND PATIENTS: Over an 11-month period, 124 consecutive patient undergoing endoscopic sphincterotomy for biliary and pancreatic disease were enrolled in a prospective and randomized manner. Sixty patients (Group A) were observed 1-3 h post procedure before discharge with follow-up at 5 days. The other 62 patients (Group B) were admitted for observation. The statistical method was Fisher test and chi 2. RESULTS: Successful endoscopic sphincterotomy was achieved in 98.3% (122/124) of patients. Eighty five patients were female and 37 male. There were 60 outpatients and 62 in-patients; endoscopic sphincterotomy was performed by choledocholithiasis in 59.9% (70 cases) and papillary stenoses in 16.4% (20 cases). Complication rates were 3.27% (four patients): three pancreatitis and one bleeding. There were three in-patients and one outpatient (p. 313). We reduce costs $324,120.00 M.N. (Mexican pesos) without compromising patient safety and outcome. CONCLUSIONS: Endoscopic sphincterotomy may be performed safely on an outpatient basis, realizing significant savings in costs.

In vitro study and in vivo application of a reusable double-channel sphincterotome.

BACKGROUND AND STUDY AIMS: Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) has been deemed to be a "cost-prohibitive" procedure, based upon the cumulative costs of one-time-use accessories and current reimbursement plans. One-time-use sphincterotomes comprise a significant component of that cost and, accordingly, we evaluated the disability and clinical usefulness of a recently introduced reusable double-channel sphincterotome. MATERIALS AND METHODS: We studied a reusable 6-Fr sphincterotome at baseline and following contamination with 10(6) Bacillus stearothermophilus. Reprocessing included a unique 30-minute ultrasonic cleaning step in lieu of manual cleaning, followed by steam sterilization. Parameters evaluated included sphincterotome function, electrical integrity, and our ability to sterilize the devices for three in vitro trials. In vivo studies included patient demographics and outcomes, procedural findings, and success rates, and the mean number of times the sphincterotome was used, functional grading at time of use, and reasons for sphincterotome malfunction. RESULTS: Ten out of ten sphincterotomes maintained form, function, and electrical integrity in vitro, and all cultures were negative after sterilization. In the initial in vivo study, ten sphincterotomes were used in 50 patients (mean, 5 uses) with a 94% success rate. Reasons for sphincterotome failure included leak or breakage of the accessory port in 70%, wire fracture in 10%, incorrect wire bow in 10%, and clogged injection port in 10%. Following reconfiguration of the insertion-port polymer, an additional ten sphincterotomes were used in 110 patients (mean, 11 uses). Mechanical failure occurred primarily at the wire-insertion port, resulting in progressive friction with reuse. There were neither electrical nor infectious complications associated with reuse. CONCLUSIONS: A reusable double-channel sphincterotome is available which can theoretically be reprocessed and sterilized without the manual cleaning step of the reprocessing process. Contingent upon both provider and patient, multiple reuse can be anticipated, and contingent upon purchase price and reprocessing costs, the potential for procedural cost savings is significant.

Prospective multicenter study comparing a standard reusable sphincterotome with a disposable triple-lumen sphincterotome.

BACKGROUND: Few data are available on the comparative performance of different types of sphincterotome. The aim of this study was to compare the efficacy of endoscopic sphincterotomy performed with either a reusable, single-lumen sphincterotome or a disposable triple-lumen instrument. METHODS: Seventy-seven consecutive adults requiring endoscopic sphincterotomy were prospectively and randomly assigned treatment with either a standard reusable single-lumen sphincterotome (group A, n = 38) or a disposable triple-lumen sphincterotome with a guidewire (group B, n = 39). The success rate, complications, and cost of the procedure per patient were compared. RESULTS: Deep cannulation was successful in 87% of cases in each group and sphincterotomy was achieved in 76% and 84% of cases in group A and B, respectively (NS). In the endoscopists' opinion the two instruments performed almost equally well. Twelve procedure-related complications occurred: 5 (all hemorrhages) in group A and 7 (1 hemorrhage, 4 cases of pancreatitis and 2 of cholangitis) in group B (NS). Eight reusable sphincterotomes were used with a cost of $61 per patient, compared with 39 disposable sphincterotomes with a cost of $241 per patient (p = 0.02). CONCLUSIONS: A standard reusable sphincterotome is satisfactory for most endoscopic sphincterotomies, and yields a substantial cost savings without compromising the success or safety of the procedure.

Biliary sphincter balloon dilation; who, when and how?

Biliary sphincter balloon dilation for biliary stone removal was introduced in 1983. In the early 1990s, several groups studied this technique further. The success rate of stone removal is comparable with that of endoscopic sphincterotomy in patients with fewer than three stones that are less then 1 cm in diameter. Fewer complications after balloon dilation than after endoscopic sphincterotomy have been noted in most studies. One study, however, showed a higher incidence of pancreatitis and, in particular, severe pancreatitis. Therefore, there is still some reluctance among endoscopists to promote balloon dilation as a routine first choice treatment. The technique, however, is accepted as the treatment of choice in patients with a bleeding tendency and those in whom the local anatomy is associated with an increased risk of complications with endoscopic sphincterotomy, such as patients with periampullary diverticula or Billroth II gastrectomy.

In vitro and in vivo evaluation of a reusable double-channel sphincterotome.

BACKGROUND: To date, one reusable, double-channel sphincterotome has been approved by the Food and Drug Administration in the United States. Whether this device can be reprocessed easily and whether it is more durable than currently manufactured disposable sphincterotomes are uncertain. METHODS: Thirty double-channel, 20 mm, braided-wire sphincterotomes approved for multiple uses were studied in vitro/in vivo with regard to durability and sterilization. A cost analysis of reusable, disposable, and reprocessed disposable sphincterotomes was also carried out. RESULTS: Three of 10 sphincterotomes evaluated in vitro broke after 3, 4, and 8 uses. Electrical integrity was preserved after 10 uses in the remaining sphincterotomes. Nine sphincterotomes remained functional for at least 3 uses, five for 6 uses, and one for 10 uses. Culture results after inoculation demonstrated contamination with surviving organisms after manual cleaning and no growth after ethylene oxide sterilization. Sixty-one procedures were performed in vivo using 20 sphincterotomes (mean number of uses 3.1). No evidence of procedurally related infection occurred with reuse. Cost per use of this reusable sphincterotome was calculated to be $62.98; it became cost effective after 2.2 and 7.9 uses when compared with disposable and reprocessed, disposable sphincterotomes, respectively. CONCLUSIONS: This reusable sphincterotome proved to be safe, easily sterilized, and electrically intact after repeated use. In vivo, however, a progressive loss of function limited the mean number of uses to 3.1. In settings that preclude reuse of reprocessed disposable accessories, this reusable sphincterotome may provide a means to decrease costs associated with endoscopic retrograde cholangiopancreatography.

Therapeutic biliary endoscopy.

Therapeutic biliary endoscopy continues to evolve; some small but important developments were seen during the last year. Competing technologies are continuing to develop.

Reuse of disposable sphincterotomes for diagnostic and therapeutic ERCP: a one-year prospective study.

BACKGROUND: Although previous studies have documented that single-channel sphincterotomes can be sterilized and used up to 10 times, no studies have prospectively evaluated the reuse of disposable sphincterotomes. METHODS: Five- and six-French double-channel sphincterotomes marketed as one-time-use only were manually cleaned, sterilized with ethylene oxide, and used up to 10 times. Over a 1-year period, total number of uses as a cannulation or cutting device, reason for sphincterotome dysfunction, possible infectious complications were evaluated, and cost-savings associated with reuse were evaluated. RESULTS: The mean number of times sphincterotomes could be used in our institution was 3.4; a broken or stiff cutting wire was the main reason for discard. There were two infectious complications during the study period. Both were experienced by patients with unrelieved obstruction treated with new sphincterotomes. Contingent on the method used, total savings related to sphincterotome reuse was approximately $66,000. CONCLUSIONS: Double-channel sphincterotomes marketed as one-time-use items can be reused safely when properly cleaned. Reuse was associated with significant cost savings in our institution.