Laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and bile duct.
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SUBMITTER: Vettoretto N
PROVIDER: S-EPMC6494553 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundStone recurrence is a significant complication following endoscopic bile duct clearance. Endoscopic papillary large-balloon dilation (EPLBD) with biliary sphincterotomy (EBS) has shown satisfactory results in preventing recurrence of "large" common bile duct stones (CBDS). However, data on outcomes after EPLBD+EBS for CBDS ≤12 mm remain scarce. The present study prospectively evaluated the mid- and long-term efficacy of EPLBD+EBS for CBDS recurrence among this group of patients.MethodsConsecutive patients with CBDS ranging from 8-12 mm, treated with EPLBD+EBS from June 2018 through June 2020, were prospectively followed-up for at least 36 months. CBDS recurrence was defined as recurrent stones confirmed by endoscopic retrograde cholangiopancreatography (ERCP) during the follow-up period.ResultsOverall, 72 patients (mean age: 67 years, 52.8% male) were included, of whom 22 (30.5%) had multiple (≥3) CBDS, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EBS. The mean CBD diameter was 11.6±1 mm, while a tapered duct was noted in 7 (9.7%). Post-procedural bleeding and cholangitis occurred in 1 and 2 cases respectively. No cases of perforation and post-ERCP pancreatitis were observed. During a mean follow up of 46.4±6.2 months (range 37-60), no mid-term recurrence was observed, whereas CBDS recurred in 2/72 (2.7%) in the long term.ConclusionsEPLBD+EBS in patients with CBDS ≤12 mm was associated with a very low rate of mid- and long-term CBDS recurrence. Our results need to be further investigated with randomized controlled trials.
| S-EPMC10785022 | biostudies-literature
Project description:BackgroundEndoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy-the two-step approach-is the standard treatment of common bile duct stones in many countries. However, ERC is associated with a high risk of complications and more than half of patients require multiple ERCs. Meta-analyses of randomised clinical trials find no major differences of the two-step approach in comparison with laparoscopic cholecystectomy with intraoperative laparoscopic stone clearance-the one-step approach. Currently, there are insufficient data to ascertain superiority.MethodsThe preGallstep trial is an investigator-initiated, multicentre randomised feasibility and pilot clinical trial with blinded outcome assessment. Eligible patients are patients with common bile duct stones (identified by magnetic resonance cholagiopancreatography), age 18 years or above with the possibility to perform both interventions within a reasonable time. We intent to randomise 150 participants allocated 1:1. The experimental intervention is the one-step approach. This consists of laparoscopic common bile duct exploration plus laparoscopic cholecystectomy. The control intervention is the two-step approach which consists of ERC plus sphincterotomy (first step) and subsequent laparoscopic cholecystectomy (second step). Feasibility outcomes include the proportion of eligible patients not wanting to participate, reasons for rejection to participate, difficulties during the informed consent procedure, difficulties with randomisation, difficulties with data management, difficulties with blinding patient charts and forms and difficulties with maintaining blinding for the outcome assessors. The primary pilot outcome is the proportion of participants with at least one postoperative complication according to the Clavien-Dindo score grade II and above until 90 days after randomisation. This outcome will be used for a future sample size calculation of a larger pragmatic trial. Further, a range of clinical explorative outcomes will be assessed.DiscussionAs no sample size is estimated in this trial, there is a risk of wrongly assessing the effect on the patient-related outcome. The surgical procedures cannot be blinded. However, blinding will be employed in all other aspects of the trial, including the establishment of a blinded outcome adjudication committee with three independent assessors. Heterogeneity in screening, randomisation, diagnostics, treatment procedures, interventions and follow-up across trial sites may cause challenges in conducting a larger pragmatic trial. To monitor inter-site differences, we have implemented a central data monitoring scheme.Trial registrationClinicalTrials.gov identification: NCT04801238 , Registered on 16 March 2021.
| S-EPMC9899655 | biostudies-literature
Project description:Background and study aims The optimal technique for removal of large common bile duct (CBD) stones (≥ 10 mm) during endoscopic retrograde cholangiopancreatography (ERCP) remains unclear. We aimed to perform a comparative analysis between different endoscopic techniques. Methods Adhering to PRISMA guidelines, a stringent search of the following databases through January 12, 2021, were undertaken: PubMed/Medline, Embase, Web of Science, and Cochrane. Randomized controlled trials comparing the following endoscopic techniques were included: (1) Endoscopic sphincterotomy (EST); (2) Endoscopic papillary large balloon dilation (EPLBD); and (3) EST plus large balloon dilation (ESLBD). Stone clearance rate (SCR) on index ERCP was the primary outcome/endpoint. Need for mechanical lithotripsy (ML) and adverse events were also evaluated as secondary endpoint. Random effects model and frequentist approach were used for statistical analysis. Results A total of 16 studies with 2545 patients (1009 in EST group, 588 in EPLBD group, and 948 patients in ESLBD group) were included. The SCR was significantly higher in ESLBD compared to EST risk ratio [RR]: 1.11, [confidence interval] CI: 1.00-1.24). Lower need for ML was noted for ESLBD (RR: 0.48, CI: 0.31-0.74) and EPLBD (RR: 0.58, CI: 0.34-0.98) compared to EST. All other outcomes including bleeding, perforation, post-ERCP pancreatitis, stone recurrence, cholecystitis, cholangitis, and mortality did not show significant difference between the three groups. Based on network ranking, ESLBD was superior in terms of SCR as well as lower need for ML and adverse events (AEs). Conclusions Based on network meta-analysis, ESLBD seems to be superior with higher SCR and lower need for ML and AEs for large CBD stones.
| S-EPMC9754880 | biostudies-literature
Project description:Backgrounds/aimsIn the absence of national registry of laparoscopic cholecystectomy (LC) or its complications, it is impossible to determine incidence of bile duct injury (BDI) in India. We conducted an e-survey among practicing surgeons to determine prevalence and management patterns of BDI in India. Our hypothesis was that majority of surgeons would have experienced a BDI during LC despite large experience and that most surgeons who have a BDI tend to manage it themselves.MethodsAn 18-question e-survey of practicing laparoscopic surgeons in India was done.Results278/727 (38%) surgeons responded. 240/278 (86%) respondents admitted to a BDI during LC and 179/230 (78%) affirmed to more than one BDI. A total of 728 BDIs were reported. 36/230 (15%) respondents experienced their first BDI even after ＞10 years of practice and 40% had their first BDI even after having performed ＞100 LCs. 161/201 (80%) of the respondents decided to manage the BDI themselves, including 56/99 (57%) non-biliary surgeons and 44/82 (54%) surgeons working in non-biliary center. 37/201 (18%) respondents admitted to having a mortality arising out of a BDI; the mortality rate of BDI was 37/728 (5%) in this survey. Only 13/201 (6%) respondents have experienced a medico-legal case related to a BDI during LC.ConclusionsPrevalence of BDI is high in India and occurs despite adequate experience and volume. Even inexperienced non-biliary surgeons working in non-biliary centers attempt to repair the BDI themselves. BDI is associated with significant mortality but litigation rates are fortunately low in India.
| S-EPMC7691207 | biostudies-literature
Project description:BACKGROUND: Bile duct injury (BDI) after cholecystectomy is a serious complication. In a small subset of patients with BDI, failure of surgical or non-surgical management might lead to acute or chronic liver failure. The aim of this study was to review the indications and outcome of liver transplantation (LT) for BDI after open and laparoscopic cholecystectomy. METHODS: Patients with BDI after cholecystectomy who were on the waiting list for LT between January 1987 and December 2010 were identified from LT centres in Spain. A standardized questionnaire was sent to each unit for extraction of data on diagnosis, previous treatments, indication and outcome of LT for BDI. RESULTS: Some 27 patients with BDI after cholecystectomy in whom surgical and non-surgical management for BDI failed were scheduled for LT over the 24-year interval. Emergency LT for acute liver failure was indicated in seven patients, all after laparoscopic cholecystectomy. Two patients died while on the waiting list and only one patient survived more than 30 days after LT. Elective LT for secondary biliary cirrhosis after a failed hepaticojejunostomy was performed in 13 patients after open and seven after laparoscopic cholecystectomy. One patient from the elective transplantation group died within 30 days of LT. The estimated 5-year overall survival rate was 68 per cent. CONCLUSION: Emergency LT for acute liver failure was more common in patients with BDI after laparoscopic cholecystectomy, and associated with a poor outcome.
| S-EPMC4253129 | biostudies-literature
Project description:BackgroundThe gold-standard treatment for cholecystectomy, laparoscopic cholecystectomy, has remarkably variable outcomes and conversion rates. We investigated the gallbladder adhesion degree as a predictor of conversion surgery, common bile duct injury, and resurgery.MethodsWe reviewed 157 medical records and video recordings of laparoscopic cholecystectomy on patients with cholelithiasis with or without cholecystitis at three hospitals in Yogyakarta, Indonesia from January 2016 to December 2018. The degree of gallbladder adhesion is classified into 4 categories: no adhesion, <50% adhesion, 50%-buried GB, and completely buried GB.ResultsOne hundred fifty seven patients were involved in this study, of whom 58 were males and 99 females with average age 49.2. Eighty-one patients out of 157 patients (51.6%) had gallbladder adhesion comprising of 61/157 (38.9%) with <50% adhesion and 20/157 (12.7%) 50%-buried GB. There is one incidence each of conversion surgery, CBD injury, and resurgery. The degree of GB adhesion has low degree of correlation with conversion surgery, CBD injury, and resurgery wirh r value of 0.156, 0.041, and 0.156 respectively. There is significant correlation between the degree of GB adhesion and conversion surgery and resurgery with p value of 0.032, and 0.032 respectively. There is no significant correlation between degree of GB adhesion and CBD injury with p value of 0.453.ConclusionThe degree of GB adhesion has low degree of correlation with conversion, CBD injury and resurgery. This study also showed that patients with high degree of gallbladder adhesion are still eligible for laparoscopic procedure performed by an experienced surgeon.
| S-EPMC8346525 | biostudies-literature
Project description:BackgroundTo assess the short-term outcomes after endoscopic sphincterotomy (EST) plus endoscopic papillary balloon dilation (EPBD) versus EPBD alone and appropriate balloon dilation time in EPBD alone.Materials and methodsA total of 413 patients with common bile duct stones (CBDSs) were included in the EST plus EPBD group and 84 were in the EPBD alone group. We retrospectively evaluated the safety and efficacy between EST plus EPBD and EPBD alone group. The patients in EPBD alone group were assigned to dilation time ?5 minutes group (n=35) and time <5 minutes group (n=49). Further, we preliminarily discussed the influence of balloon dilation time on the procedure-related complications.ResultsCompared with EST plus EPBD, the patients in EPBD alone group were younger [56.6 (range: 18 to 95) vs. 65.1 (24 to 92) y; P=0.006], had smaller diameter of the largest stone [10.4 (range: 3 to 20) vs. 12.3 (5 to 30) mm; P<0.001] and were lesser frequently performed with jaundice [22 (26.2%) vs. 189 (45.8%); P=0.001]. The mean duration of postoperative hospital stay in EPBD alone group was significantly shorter than EST plus EPBD group [6.3 (range: 1 to 18) vs. 9.2 (1 to 44) d; P<0.001]. The patients in EPBD alone group had higher risk of post endoscopic retrograde cholangiopancreatography pancreatitis than EST plus EPBD group [11 (13.1%) vs. 22 (5.3%); P=0.009]. Patients in the dilation time <5 minutes group had higher risk to suffer from postoperative pancreatitis than the EST plus EPBD group [9 (18.4%) vs. 22 (5.3%); P=0.002], while patients in the dilation time ?5 minutes group had less procedure-related hemorrhage than the EST plus EPBD group [0 vs. 36 (8.7%); P=0.047].ConclusionLong balloon dilation time in EPBD alone is safe and effective in treating CBDSs.
| S-EPMC5633320 | biostudies-literature
Project description:Background and study aimsBile stones represent a highly prevalent condition and abnormalities of the biliary tree predispose to stone recurrence due to development of biliary stasis. In our study, we assessed the importance of an altered bile duct course for stone formation.Patients and methods1,307 patients with choledocholithiasis in the absence of any associated hepatobiliary disease who underwent endoscopic retrograde cholangiopancreatography (ERCP) between 2002 and 2009 were analysed. The angle enclosed between the horizontal portion of the common bile duct (CBD) and the horizontal plane was measured (angle ?). Oblique common bile duct (OCBD) was defined as a CBD with angle ? < 45°.Results103 patients (7.9%) were found to harbour OCBD and these were compared to 104 randomly selected control subjects. Compared to controls, OCBD patients were (i) significantly older (72 ± 13 vs. 67 ± 13, p<0.00001); (ii) more frequently underwent a cholecystectomy (p = 0.02) and biliary surgery (p = 0.003) prior to the diagnosis and (iii) more often developed chronic pancreatitis (p = 0.04) as well as biliary fistulae (p = 0.03). Prior to and after ERCP, OCBD subjects displayed significantly elevated cholestatic parameters and angle ? negatively correlated with common bile duct diameter (r = -0.29, p = 0.003). OCBD subjects more often required multiple back-to-back ERCP sessions to remove bile stones (p = 0.005) as well as more ERCPs later on due to recurrent stone formation (p<0.05).ConclusionOCBD defines a novel variant of the biliary tree, which is associated with chronic cholestasis, hampers an efficient stone removal and predisposes to recurrence of bile duct stones.
| S-EPMC3554756 | biostudies-literature
Project description:IntroductionSurgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed preoperatively for their risk of CBD stones using liver function tests and imaging. If the risk is high, guidelines recommend further investigation and treatment. Further investigation of patients at low or moderate risk of CBD stones is not standardised, and the practice of imaging the CBD using magnetic resonance cholangiopancreatography (MRCP) in these patients varies across the UK. The consequences of these decisions may lead to overtreatment or undertreatment of patients.Methods and analysisWe are conducting a UK multicentre, pragmatic, open, randomised controlled trial with internal pilot phase to compare the effectiveness and cost-effectiveness of preoperative imaging with MRCP versus expectant management (ie, no preoperative imaging) in adult patients with symptomatic gallbladder disease undergoing urgent or elective LC who are at low or moderate risk of CBD stones. We aim to recruit 13 680 patients over 48 months. The primary outcome is any hospital admission within 18 months of randomisation for a complication of gallstones. This includes complications of endoscopic retrograde cholangiopancreatography for the treatment of gallstones and complications of LC. This will be determined using routine data sources, for example, National Health Service Digital Hospital Episode Statistics for participants in England. Secondary outcomes include cost-effectiveness and patient-reported quality of life, with participants followed up for a median of 18 months.Ethics and disseminationThis study received approval from Yorkshire & The Humber - South Yorkshire Research Ethics Committee. Results will be submitted for publication in a peer-reviewed journal.Trial registration numberISRCTN10378861.
| S-EPMC8245448 | biostudies-literature
Project description:BackgroundThe pathological evaluation of tissues with cholangitis is considered difficult, which can often occur after endoscopic sphincterotomy (EST) and endoscopic biliary stenting (EBS). This study aimed to evaluate the influence of a history of EST and EBS on the sensitivity of transpapillary forceps bile duct biopsy (TB) for bile duct adenocarcinoma.MethodsThis retrospective study included consecutive cases of bile duct adenocarcinoma in which TB was performed before July 2020 until the number exceeded that required to support statistical and noninferiority analyses of the sensitivity of TB between patients with and without each variable. The incidence of postprocedural adverse events related to each factor was also investigated.ResultsOverall, 280 samples were required in each group, and 437 subjects (792 samples) were included. The sensitivity of TB was 63.6% for the subjects and 59.6% for the biopsy samples. For the biopsy samples, the sensitivity did not differ significantly between samples from patients with and without a history of EST (59.1% vs. 58.9%, P = 0.952) and EBS (62.1% vs. 55.4%, P = 0.065). The sensitivity was significantly higher for samples from patients with jaundice (67.9% vs. 57.0%, P = 0.008). There were significantly fewer procedure-related adverse events in patients with a history of EST (10.8% vs. 19.0%, P = 0.017) and EBS (12.0% vs. 21.7%, P = 0.005).ConclusionsA history of EST or EBS did not influence sensitivity of TB but significantly decreased the incidence of adverse events. To safely and reliably perform TB to diagnose bile duct adenocarcinoma, planning, including for EST and EBS, is necessary.
| S-EPMC9258154 | biostudies-literature