Dataset Information

Endoscopic clearance of non-complex biliary stones using fluoroscopy-free direct solitary cholangioscopy: Initial multicenter experience.

ABSTRACT:

Background and aims

Fluoroscopy-free endoscopic retrograde cholangiopancreatography for common bile duct stone (CBDS) clearance is usually offered only to pregnant patients. We initiated a multicenter, randomized controlled trial comparing clearance of non-complex CBDSs using fluoroscopy-free direct solitary cholangioscopy (DSC) to standard endoscopic retrograde cholangiography (ERC) to evaluate the wider applicability of the DSC-based approach. Here we report the initial results of stone clearance and safety in roll-in cases for the randomized controlled trial.

Methods

Twelve expert endoscopists at tertiary care centers in four countries prospectively enrolled 47 patients with non-complex CBDSs for DSC-assisted CBDS removal in an index procedure including fluoroscopy-free cannulation. Successful CBDS clearance was first determined by DSC and subsequently validated by final occlusion cholangiogram as the ERC gold standard.

Results

Fully fluoroscopy-free cannulation was successful in 42/47 (89.4%) patients. Brief fluoroscopy with minimal contrast injection was used in 4/47 (8.5%) patients during cannulation. Cannulation failed in 1/47 (2.1%) patients. Fluoroscopy-free complete stone clearance was reached in 38/46 (82.6%) cases. Residual stones were detected in the validation ERC occlusion cholangiogram in three cases. Overall serious adverse event rate was 2.1% (95% confidence interval 0.1-11.3): postprocedural pancreatitis in one patient.

Conclusions

In patients with non-complex CBDS, the fluoroscopy-free technique is easily transferred to endoscopic retrograde cholangiopancreatography experts with acceptable rates of cannulation and stone clearance and few serious adverse events. (ClinicalTrials.gov number, NCT03421340).

SUBMITTER: Ridtitid W

PROVIDER: S-EPMC10235796 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

Endoscopic clearance of non-complex biliary stones using fluoroscopy-free direct solitary cholangioscopy: Initial multicenter experience.

Ridtitid Wiriyaporn W Rerknimitr Rungsun R Ramchandani Mohan M Lakhtakia Sundeep S Shah Raj J RJ Shah Janak N JN Thosani Nirav N Goenka Mahesh K MK Costamagna Guido G Wagh Mihir S MS Perri Vincenzo V Peetermans Joyce J Goswamy Pooja G PG Liu Zoe Z Yin Srey S Banerjee Subhas S

DEN open 20230601 1

<h4>Background and aims</h4>Fluoroscopy-free endoscopic retrograde cholangiopancreatography for common bile duct stone (CBDS) clearance is usually offered only to pregnant patients. We initiated a multicenter, randomized controlled trial comparing clearance of non-complex CBDSs using fluoroscopy-free direct solitary cholangioscopy (DSC) to standard endoscopic retrograde cholangiography (ERC) to evaluate the wider applicability of the DSC-based approach. Here we report the initial results of ston ...[more]

PMID: 37273518

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Project description:Background and aimsEndoscopic retrograde cholangiopancreatography is the preferred strategy for the management of biliary and pancreatic duct stones. However, difficult stones occur, and electrohydraulic (EHL) and laser lithotripsy (LL) have emerged as treatment modalities for ductal clearance. Recently, single-operator cholangioscopy was introduced, permitting the routine use of these techniques. We aimed to evaluate the clinical effectiveness of cholangioscopy-guided lithotripsy using LL or EHL in patients with difficult biliary or pancreatic stones.MethodsThis is a prospective clinical study - conducted at two affiliated university hospitals - of 17 consecutive patients with difficult biliary and pancreatic stones who underwent single-operator cholangioscopy-guided lithotripsy using two techniques: holmium laser lithotripsy (HL) or bipolar EHL. We analyzed complete ductal clearance as well as the impact of the location and number of stones on clinical success and evaluated the efficacy of the two techniques used for cholangioscopy-guided lithotripsy and procedural complications.ResultsTwelve patients (70.6%) had stones in the common bile duct/common hepatic duct, 2 patients (17.6%) had a stone in the cystic stump, and 3 patients (17.6%) had stones in the pancreas. Sixteen patients (94.1%) were successfully managed in 1 session, and 1 patient (5.9%) achieved ductal clearance after 3 sessions including EHL, LL, and mechanical lithotripsy. Eleven patients were successfully submitted to HL in 1 session using a single laser fiber. Six patients were treated with EHL: 4 patients achieved ductal clearance in 1 session with a single fiber, 1 patient obtained successful fragmentation in 1 session using two fibers, and 1 patient did not achieve ductal clearance after using two fibers and was successfully treated with a single laser fiber in a subsequent session. Complications were mild and were encountered in 6/17 patients (35.2%), including fever (n = 3), pain (n = 1), and mild pancreatitis (n = 1). Conclusions: Cholangioscopy-guided lithotripsy using LL or EHL in patients with difficult biliary or pancreatic stones is highly effective with transient and minimal complications. There is a clear need to further compare EHL and HL in order to assess their role in the success of cholangioscopy-guided lithotripsy.

Project description:Conventional endoscopic duct clearance may not be possible in up to 10%-15% of common bile duct stones (CBDS). Sphincterotomy and biliary drainage by endoprosthesis have for many years been the mainstay of management in irretrievable stones. Recent years have seen the advent of sphincteroplasty or cholangioscopically-guided electrohydraulic lithotripsy (EHL) permitting duct clearance in majority of cases. However, when bile duct clearance is not possible, options include long-term stenting followed by elective stent exchange (ESE) 6-12 monthly or permanent stent insertion (PSI) in selected cases, but it is not clear which management strategy among ESE and PSI is preferable.A retrospective review of all patients in Leeds Teaching Hospitals NHS Trust who underwent plastic stent insertion for biliary access for difficult CBDS from January 2006 to December 2011 was undertaken. Adult patients with irretrievable CBDS who had plastic stent insertions throughout the follow-up period were included. Patients who underwent PSI and ESE annually were retrospectively reviewed to determine the long-term outcomes. A detailed systematic review was also performed, examining the outcomes of CBDS managed with stents.During the study period, 674 patients underwent 1769 biliary-stent-related procedures; of which, 246 patients met our inclusion criteria. 201 patients had subsequent duct clearance. 45 patients were, therefore, included in the final analysis, 28 of whom underwent annual ESEs and 17 PSIs. Patients in the PSI group had higher American Society of Anesthesiologists (ASA) scores compared with the ESE group. In the PSI group, 9/17 patients presented acutely with blocked stents, 5 of whom presented within 12 months. 2/9 patients were severely ill and died within a fortnight following the repeat endoscopic retrograde cholangiopancreatography (ERCP). In the ESE group, 4/28 patients had duct clearance in subsequent ERCPs, 1/28 patient presented with a blocked stent, and no biliary-related deaths were observed. The mean numbers of ERCPs performed were 0.52 and 1.95 in the PSI and ESE groups, respectively.Over 50% of patients treated with long-term stenting re-presented acutely with stent blockage, though many of these were before 12 months, meaning planned stent exchange would not have affected the outcome. Duct clearance using all possible modalities is the preferred option, but where not possible, management with biliary stenting either with elective exchange or permanent stenting remains a possibility for carefully selected patients, though maybe best suited to those with limited life expectancy.

Dataset Information

Endoscopic clearance of non-complex biliary stones using fluoroscopy-free direct solitary cholangioscopy: Initial multicenter experience.

Background and aims

Methods

Results

Conclusions

Publications

Endoscopic clearance of non-complex biliary stones using fluoroscopy-free direct solitary cholangioscopy: Initial multicenter experience.

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