One-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus two-step endoscopic retrograde cholangiography with stone extraction plus laparoscopic cholecystectomy for patients with common bile duct stones: a randomised feasibility and pilot clinical trial-the preGallStep trial.

BACKGROUND: Endoscopic 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. METHODS: The 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. DISCUSSION: As 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 REGISTRATION: ClinicalTrials.gov identification: NCT04801238 , Registered on 16 March 2021.

Contemporary management of concomitant gallstones and common bile duct stones: a survey of Spanish surgeons.

BACKGROUND: Concomitant gallstones and common bile duct stones (CBDS) is a relatively frequent presentation. The optimal treatment remains controversial and the debate persists between two strategies. The one-stage approach: laparoscopic cholecystectomy with laparoscopic common bile duct exploration (LCBDE) has been shown to be equally safe and more cost-effective than the more traditional two-stage approach: endoscopic retrograde cholangiography followed by laparoscopic cholecystectomy (ERCP + LC). However, many surgeons worldwide still prefer the two-stage procedure. This survey evaluated contemporary management of CBDS in Spain and assessed the impact of surgeon and hospital factors on provision of LCBDE. METHODS: A 25-item, web-based anonymous survey was sent to general surgeons members of the Spanish Surgeons Association. Descriptive statistics were applied to summarize results. RESULTS: Responses from 305 surgeons across 173 Spanish hospitals were analyzed. ERCP is the initial approach for preoperatively suspected CBDS for 86% of surgeons. LCBDE is the preferred method for only 11% of surgeons and only 11% treat more than 10 cases per year. For CBDS discovered intraoperatively, 59% of respondents attempt extraction while 32% defer to a postoperative ERCP. The main reasons cited for not performing LCBDE were lack of equipment, training and timely availability of an ERCP proceduralist. Despite these barriers, most surgeons (84%) responded that LCBDE should be implemented in their departments. CONCLUSIONS: ERCP was the preferred approach for CBDS for the majority of respondents. There remains limited use of LCBDE despite many surgeons indicating it should be implemented. Focused planning and resourcing of both training and operational demands are required to facilitate adoption of LCBDE as option for patients.

Combined gastroscopic and choledochoscopic transabdominal nasobiliary drainage.

Common bile duct (CBD) stones are a frequent problem in Chinese populations, and their incidence is particularly high in certain areas (Wang et al., 2013). In recent years, laparoscopic common bile duct exploration (LCBDE) and endoscopic retrograde cholangiopancreatography (ERCP) have been the main surgical procedures for CBD stones, although each has different advantages and disadvantages in the treatment of choledocholithiasis (Loor et al., 2017; Zhou et al., 2017). For patients with large stones, a dilated CBD, especially concurrent gallstones, LCBDE is the preferred and most economical minimally invasive procedure (Koc et al., 2013). However, a T-tube is often placed during LCBDE to prevent postoperative bile leakage; this is associated with problems such as bile loss, electrolyte disturbance, and decreased gastric intake (Martin et al., 1998). In addition, the T-tube usually must remain in place for more than a month, during which time the patient's quality of life is seriously compromised. Many skilled surgeons currently perform primary closure of the CBD following LCBDE, which effectively speeds up rehabilitation (Hua et al., 2015). However, even in sophisticated medical centers, the incidence of postoperative bile leakage still reaches ≥10% (Liu et al., 2017). Especially for a beginner, bile leakage remains a key problem (Kemp Bohan et al., 2017). Therefore, a safe and effective minimally invasive surgical approach to preventing bile leakage during primary closure of the CBD after LCBDE is still urgently needed.

Combined gastroscopic and choledochoscopic transabdominal nasobiliary drainage / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

Common bile duct (CBD) stones are a frequent problem in Chinese populations, and their incidence is particularly high in certain areas (Wang et al., 2013). In recent years, laparoscopic common bile duct exploration (LCBDE) and endoscopic retrograde cholangiopancreatography (ERCP) have been the main surgical procedures for CBD stones, although each has different advantages and disadvantages in the treatment of choledocholithiasis (Loor et al., 2017; Zhou et al., 2017). For patients with large stones, a dilated CBD, especially concurrent gallstones, LCBDE is the preferred and most economical minimally invasive procedure (Koc et al., 2013). However, a T-tube is often placed during LCBDE to prevent postoperative bile leakage; this is associated with problems such as bile loss, electrolyte disturbance, and decreased gastric intake (Martin et al., 1998). In addition, the T-tube usually must remain in place for more than a month, during which time the patient's quality of life is seriously compromised. Many skilled surgeons currently perform primary closure of the CBD following LCBDE, which effectively speeds up rehabilitation (Hua et al., 2015). However, even in sophisticated medical centers, the incidence of postoperative bile leakage still reaches ≥10% (Liu et al., 2017). Especially for a beginner, bile leakage remains a key problem (Kemp Bohan et al., 2017). Therefore, a safe and effective minimally invasive surgical approach to preventing bile leakage during primary closure of the CBD after LCBDE is still urgently needed.

Comparison of Bile Drainage Methods after Laparoscopic CBD Exploration.

PURPOSE: T-tube is a major procedure that prevents complication by biliary decompression, but which is accompanied by complications. Therefore, several procedures such as ENBD, PTBD, and antegrade biliary stent have been attempted, but with controversies as to which procedure is superior. Also, there are no standard procedures after laparoscopic CBD exploration. We performed this study to ascertain the most appropriate biliary drainage procedure after laparoscopic CBD exploration. METHODS: From March 2001 to December 2009, 121 patients who underwent Laparoscopic CBD exploration in Gunyang University were included for retrospective analysis. The patients were divided to 4 groups according to type of procedure, and we compared clinical parameters including age and gender, operation time, hospital stay, start of post-operative diet, and complications. RESULTS: There was no difference in age, gender, mean operation time, postoperative diet between the 4 groups. Hospital stay in the Stent group was shorter than T-tube group. There were 10 (7%) complications that occurred. Two 2 occurred in the T-tube, 3 in PTBD, and 5 in the Antegrade stent group. There were more complications in Stent group but no significant statistical difference. In 5 cases with remnant CBD stone, a total of 4 (3 PTBD, 1 Stent) was performed by endoscopic CBD stone removal. One T-tube case was removed easily by choledochoscopy through the T-tube. Three migrated and the impacted stents were removed by additional endoscopy. Perioperative biliary leakage (1) and peritonitis (1) post t-tube removal were resolved by conservative treatment. CONCLUSION: T-tube appears to be an appropriate method to patients who are suspected to have remnant CBD stones. Multiple procedures may be performed on a case by case basis such as performing PTBD first in a suspected cholangitis patient.

The Clinical Outcome of Laparoscopic Common Bile Duct Exploration for the Primary Treatment of Choledocholithiasis

PURPOSE: For choledocholithiasis, many doctors routinely use ERCP/EST to avoid the need for common bile duct exploration. But, ERCP/EST has some weakpoints. So it may not be a first choice for management, especially in secondary hospitals. Therefore, we investigated and reviewed results of LCBDE as a first treatment for common bile duct stones. METHODS: This study was a retrospective analysis of 60 cases that could be reviewed by their medical charts and who underwent LCBDE performed by the same surgeon at the Yeosu Chonnam Hospital between March, 1996 and August, 2009. The clinical data were compared between each two groups (1996~1999 vs 2000~2009 years, primary closure vs T tube drainage). RESULTS: Between groups A and B, there were no significant differences in preoperative status of the patient except for age (60.5 vs 72.6). The average operative time was decreased in group B (171.6 mins vs 143.0 mins) and the number of trocars was decreased in group B (4 vs 3.2). There were 13 postoperative complications. Among them, 11 were cases of bile leakage. All of the bile leakage cases were in group B. And there were more bile leakages in the primary repair group than in T tube drainage group (50% vs 8.9%). But, 10 cases of bile leakage were improved completely by observation and conservative treatment. CONCLUSION: LCBDE is a safe and useful treatment that has several advantages and can overcome problems not solved by ERCP. Fatal complications were not increased in the primary repair group compared with the T tube drainage group.

Comparison of Bile Drainage Methods after Laparoscopic CBD Exploration

PURPOSE: T-tube is a major procedure that prevents complication by biliary decompression, but which is accompanied by complications. Therefore, several procedures such as ENBD, PTBD, and antegrade biliary stent have been attempted, but with controversies as to which procedure is superior. Also, there are no standard procedures after laparoscopic CBD exploration. We performed this study to ascertain the most appropriate biliary drainage procedure after laparoscopic CBD exploration. METHODS: From March 2001 to December 2009, 121 patients who underwent Laparoscopic CBD exploration in Gunyang University were included for retrospective analysis. The patients were divided to 4 groups according to type of procedure, and we compared clinical parameters including age and gender, operation time, hospital stay, start of post-operative diet, and complications. RESULTS: There was no difference in age, gender, mean operation time, postoperative diet between the 4 groups. Hospital stay in the Stent group was shorter than T-tube group. There were 10 (7%) complications that occurred. Two 2 occurred in the T-tube, 3 in PTBD, and 5 in the Antegrade stent group. There were more complications in Stent group but no significant statistical difference. In 5 cases with remnant CBD stone, a total of 4 (3 PTBD, 1 Stent) was performed by endoscopic CBD stone removal. One T-tube case was removed easily by choledochoscopy through the T-tube. Three migrated and the impacted stents were removed by additional endoscopy. Perioperative biliary leakage (1) and peritonitis (1) post t-tube removal were resolved by conservative treatment. CONCLUSION: T-tube appears to be an appropriate method to patients who are suspected to have remnant CBD stones. Multiple procedures may be performed on a case by case basis such as performing PTBD first in a suspected cholangitis patient.

The Outcome of Laparoscopic Common Bile Duct Exploration (LCBDE) with Stone Removal in Common Bile Duct Stone / 대한내시경복강경외과학회지

PURPOSE: ERCP (Endoscopic retrograde cholangiopancreatigraphy) and ES (endoscopic sphicterotomy) have become the main treatments for common bile duct (CBD) stone. However, when ERCP with ES fails to remove CBD stone, an operation is needed for stone removal. The aim of this study was to investigate the outcomes of laparoscopic CBD exploration (LCBDE) for the management of difficult choledocholothoasis. METHODS: This study was a retrospective analysis of 106 LCBDE cases that were performed from March 2001 to December, 2009. RESULTS: Of the 106 patients who underwent laparoscopic procedures, 74 were combined with gallstone and 105 underwent the choledochotomy approach. The mean operation time and mean hospital stay were 146.9+/-74.5 minutes and 11.0+/-6.4 days, respectively. The open conversion and stone clearance rates were 3.8% (4 cases) and 96% (102/106 cases). There were 10 complications with 3 cases of bile leakage, 2 cases of pulmonary complications, 4 cases of remnant stone and 1 case of subhepatic seroma. CONCLUSION: The LCBDE is a safe and feasible procedure. If ERCP is difficult or stone retrieval is incomplete, then LCBDE could be an alternative treatment for difficult CBD stone.

Laparoscopic Common Bile Duct Exploration in Patients with Failed Endoscopic Stone Extraction

PURPOSE: Laparoscopic common bile duct exploration (LCBDE) has more advantages than conventional common bile duct surgery, but the use of this route for stone removal and biliary drainage remains controversial. The goal of this study was to investigate the usefulness of LCBDE in patients who had been failed in the endoscopic stone extraction. METHODS: From November 2005 to August 2008, 52 patients underwent LCBDE due to failure of endoscopic stone extraction in Chungnam National University Hospital. Clinical data were collected and analyzed retrospectively. RESULTS: Duodenal diverticulum (23 cases, 44.2%) was the most common cause in failure of endoscopic stone extraction and large common bile duct stone 12 cases (23.1%), previous upper gastrointestinal operation 10 cases (19.2%) were followed. Twenty four patients did not have preoperative biliary drainage, such as PTBD, ENBD, PTGBD. Forty-five patients (86.5%) of the 52 participating patients underwent LCBDE successfully, but 7 cases resulted in open surgery for the following reasons: 3 cases of severe intraabdominal adhesions, 3 cases of stone impaction in ampulla portion, and 1 case of a remnant stone. External biliary drainage was performed in 41 cases with T-tube (31 cases, 68.9%), PTBD (7 cases, 15.6%), ENBD (3 cases, 6.7%). The stone clearance of LCBDE was 95.6%. Remnant stone weredetected in 2 cases (4.4%) and removed with choledochoscope via external biliary drain. Postoperative complications happened in 5 cases (9.5%). Procedure related complications happened in 2 cases (3.8%). CONCLUSION: LCBDE is useful technique in patients with failed endoscopic stone extraction, and biliary drainage may be necessary for detection and removal of latent remnant CBD stones.

The Outcome of Laparoscopic Common Bile Duct Exploration (LCBDE) for the Choledocholithiasis that ERCP Failed to Remove

PURPOSE: With the advent of endoscopic technology, ERCP (endoscopic retrograde cholangiopancreatography)/ES (endoscopic sphincterotomy) has become the main treatment for CBD stones. However, when ERCP fails to remove CBD stones, it remains unclear whether laparoscopic treatment is an alternative or not. The aim of this study was to investigate the outcome of LCBDE for the management of difficult choledocholithiasis. METHODS: This study was a retrospective analysis of 68 LCBDE cases that were performed at the Ewha Womans University School of Medicine, Mokdong Hospital from January, 2000 to March, 2006. Group A was defined that primary LCBDE was performed without ERCP/ES. Group B was defined that secondary LCBDE was performed after ERCP/ES had failed. The operative outcomes and postoperative complications were compared between the two groups. RESULTS: Primary LCBDE was performed for 33 patients (Group A) and secondary LCBDE after failure of ERCP/ES was performed for 35 patients (Group B). No significant differences in gender, mean age and associated diseases were noted between the two groups. The stone clearance rate was 100% for both groups. There were no significant differences between the two groups for the mean operative time (201.5 min for Group A vs 188.7 min for Group B: P=0.415), the open conversion rate (9.1% vs 0%, respectively: P=0.068), the complication rate (12.1% vs 8.6%, respectively: P=0.630) and the duration of the hospital stay (14.3 days vs 11.9 days, respectively: P=0.169). The recurrence rate along with a mean follow-up of 24 months showed no significant difference between the two groups (12.1% vs 2.9%, respectively). CONCLUSION: When ERCP is impossible or stone retrieval is incomplete, LCBDE is an alternative treatment for difficult CBD stones.