Comparison of LCBDE vs ERCP + LC for Choledocholithiasis

NCT ID: NCT02515474

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2024-01-01

Brief Summary

Protection of Oddi's sphincter remains a huge argument especially in the long term complications like common bile duct stone recurrence or cholangitis after ERCP, which determined to destroy the sphincter of Oddi. The purpose of this study is to compare the long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.

Detailed Description

Cholelithiasis, a common etiology factor responsible for abdominal pain, is highly prevalent worldwide. According to data from general investigation, the morbidity of cholelithiasis differs from 2.36% to 42% in different areas, and about 5% to 29% (average 18%) of all cholelithiasis cases have both gallbladder stone and common bile duct stone. In the population with age above 70 years old, 30% of which suffers from gallbladder stone in China. A causal link between the development of gallbladder stone and common bile duct stone is that 10% to 15% of gallstone patients have high potential to develop secondary common bile duct stone. In 1987, the laparoscopic cholecystectomy (LC) came into being as a revolutionary surgical method. With minimally invasive effect and high safety, LC was soon accepted as a 'Golden standard' for the treatment of gallbladder stone. Endoscopic sphincterotomy (EST) was firstly reported by Kawai and Classen in 1970. As of now, the combination of EST with other endoscopic techniques, such as basket extraction, balloon dilation and lithotripsy, have significantly improved the stone removal rate from 85% up to 90%, and ERCP has been considered as the optimal method in regard to CBD stone treatment. In 1991, the laparoscopic common bile duct exploration (LCBDE) which reflected the advantage of rigid scopes had risen to be a very promising minimally invasive alternative for the treatment of common bile duct (CBD) stone. Currently, there are mainly two kinds of minimally invasive treatments for choledocholithiasis, which refers to the "one-stage" laparoscopic method, LCBDE and the "sequential two-stage" method, ERCP followed by LC. Both methods are able to achieve the same therapeutic purpose. However, there has always been a controversy about the advantages and disadvantages due to lack of evidence from long-term follow-ups, especially the difference of long-term complications related to Oddi's sphincter functional status, which importantly refers to stone recurrence rates and cholangitis.

The potential long-term complications resulted from EST remains an issue now. It is believed that EST handles Oddi's sphincter stenosis, regurgitation cholangitis, and higher cholangiocarcinoma risks in a long run. By virtue of ERCP, multiple high stone clearance rates (87%~97%) were reported, but meanwhile high re-ERCP rates (around 25%) were also indicated because of stone residual, and whether great stone residual rates was linked to future stone recurrence and repeated cholangitis is not clear. Several randomized controlled trial (RCT) studies had compared ERCP plus LC and LCBDE, the results were similar to the aspects of stone removal rates, costs, and patient acceptance. However, the postoperative cholangitis rate of one single center study is quite different from another. Moreover, few studies have related the stone recurrence rate in the long term follow-up. Obviously, previous RCT studies were limited by few comparison of ERCP followed by LC versus LCBDE in long-term complications, especially stone recurrence and cholangitis. Therefore, this multicenter randomize control study is designed prospectively to compare the stone recurrence and cholangitis rates between ERCP plus LC and LCBDE which can reflects the valuable of Oddi's sphincter protection during the disease management, further dedicating the treatment of gallbladder and common duct stone.

Conditions

Choledocholithiasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LCBDE group (single step)

Choledocholithiasis patient, after Laparoscopic Cholecystectomy (LC) to remove the gallbladder, Laparoscopic Common Bile Duct Exploration (LCBDE) was performed for removing the bile duct stone(s) in laparoscopy. Choledochoscope detection or cholangiograms should be chosen as a method of obtain stone clearance. T-tube was acceptable if needed.

Group Type: ACTIVE_COMPARATOR

Laparoscopy

Intervention Type: PROCEDURE

After removing the gallbladder, Laparoscopic common bile duct exploration (LCBDE) was performed by one fulltime attending in laparoscopy in a routine fashion. Access from the opening of the anterior wall of common bile duct or from the dilated cystic duct was acceptable, removed stone(s) and irrigated the duct followed by choledochoscope detection simultaneously. Cholangiograms were also can be a alternative method to obtain stone clearance. If needed, all fluoroscopy was performed by the principal author in the presence of and concurrence with the ERCP endoscopist. Once the LCBDE was completed, the incision of the bile duct was sewed intermittently by absorbed threads, or ligated cystic duct. T-tube was acceptable if needed.

ERCP group (sequential step)

Choledocholithiasis patient, Endoscopic Retrograde cholangiopancreatography (ERCP) was performed for removing the bile duct stone(s) in endoscopy prior to Laparoscopic Cholecystectomy (LC). Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be chosen accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.

Group Type: ACTIVE_COMPARATOR

Endoscopy

Intervention Type: PROCEDURE

Initially endoscopic retrograde cholangiopancreatography (ERCP) was performed by a fulltime attending and concurrence of the principal author in endoscopy. Patients randomized to ERCP+ LC group were scheduled to undergo the endoscopic procedure using fluoroscopy in the endoscopy center under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Gastric intestinal atony during ERCP was routinely achieved using scopolamine butylbromide injection. Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be choose accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.

Interventions

Laparoscopy

After removing the gallbladder, Laparoscopic common bile duct exploration (LCBDE) was performed by one fulltime attending in laparoscopy in a routine fashion. Access from the opening of the anterior wall of common bile duct or from the dilated cystic duct was acceptable, removed stone(s) and irrigated the duct followed by choledochoscope detection simultaneously. Cholangiograms were also can be a alternative method to obtain stone clearance. If needed, all fluoroscopy was performed by the principal author in the presence of and concurrence with the ERCP endoscopist. Once the LCBDE was completed, the incision of the bile duct was sewed intermittently by absorbed threads, or ligated cystic duct. T-tube was acceptable if needed.

Intervention Type: PROCEDURE

Endoscopy

Initially endoscopic retrograde cholangiopancreatography (ERCP) was performed by a fulltime attending and concurrence of the principal author in endoscopy. Patients randomized to ERCP+ LC group were scheduled to undergo the endoscopic procedure using fluoroscopy in the endoscopy center under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Gastric intestinal atony during ERCP was routinely achieved using scopolamine butylbromide injection. Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be choose accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.

Intervention Type: PROCEDURE

Other Intervention Names

Laparoscopic common bile duct exploration (LCBDE); Endoscopic Retrograde cholangiopancreatography (ERCP)

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years old
• Choledocholithiasis patient did not perform any operation
• Common bile duct stone less than 2cm in maximum diameter

Exclusion Criteria

• Unwillingness or inability to consent for the study
• Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count (<50×109 / L) or using anti-coagulation drugs
• Previous EST, EPBD or percutaneous transhepatic biliary drainage (PTBD)
• Prior surgery of Bismuth Ⅱ and Roux-en-Y
• Benign or malignant CBD stricture
• Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock
• Combined with Mirizzi syndrome and intrahepatic bile duct stones
• Malignancies
• Biliary-duodenal fistula confirmed during ERCP
• Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Xun Li

professor of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xun Li, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

The first hospital of Lanzhou University

Lanzhou, Gansu, China

Union hospital,Tongji medical collage,Huazhong University of science and technology

Wuhan, Hubei, China

Second Xiangya Hospital, Central South University

Changsha, Hunan, China

The First Hospital of Jilin University

Changchun, Jilin, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Shandong jiaotong Hospital

Jinan, Shandong, China

The first affiliated hospital of Xi 'an jiaotong university

Xi’an, Shanxi, China

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Southwest Hospital of Third Military Medical University

Chongqing, , China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Tianjin Nankai Hospital

Tianjin, , China

Countries

China

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Other Identifiers

Complications of LCBED vs ERCP

Identifier Type: -

Identifier Source: org_study_id