Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis

Sponsor

Lumbini Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT04213092

Collaborator

(none)

160

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The ideal management of cholecysto-choledocholithiasis is an open cholecystectomy (OC) with the common bile duct (CBD) exploration worldwide. The single setting 2-stage approach- endoscopic retrograde cholangiopancreatography (ERCP), endoscopic sphincterotomy (EST), and CBD clearance followed by laparoscopic cholecystectomy (LC) offers an advantage, mainly by reducing the hospital stay, the cost, and the morbidity. Investigators did a prospective study in patients admitted for the management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012- October 2015. They underwent 2-stage ERCP+LC in a single setting and investigators compared them with 2-stage OC+CBD exploration in a single setting approach. The patients with the open procedure were the investigator's control groups. All the included cases in the study were elective.

Condition or Disease	Intervention/Treatment	Phase
Choledocholithiasis With Cholecystitis With Obstruction Choledocholithiasis With Acute and Chronic Cholecystitis Cholelithiasis With Acute and Chronic Cholecystitis	Procedure: ERCP+LC Procedure: OC+CBD

Detailed Description

This was a prospective study done on patients admitted for management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012 - October 2015. This is a peripheral setting hospital located in a remote city of Nepal-"Palpa". The study was approved by the institutional ethical committee- "IRC of Lumbini Medical College and Teaching Hospital" and written consent was obtained from all of the patients. A comprehensive literature search published in English was done till 2019 using Hinari, PubMed, Cochrane Library, EMBASE, Web of Science, and ScienceDirect.

This is an interim analysis of 160 patients with 83 (51.9%) patients in ERCP+LC and 77 (48.1%) in open procedure (OC with CBD exploration) group respectively. The primary objective was to compare the single setting ERCP+LC with OC+CBD exploration and the secondary objectives were to study 1) the feasibility of the procedure, 2) detect the morbidity (cholangitis, pancreatitis, abdominal collection, and wound infection), 3) the length of stay, and ). The stone clearance respectively. The investigators defined their single-setting procedure as ERCP followed by LC. The patients from an open procedure group were those who underwent the procedure before our team was trained to carry out the ERCP. This open procedure group also included 10 patients who underwent open surgery due to unsuccessful ERCP. And finally, investigators compared ERCP+LC group with those who underwent the open procedure. The inclusion and exclusion criteria for ERCP+LC and open procedure are shown in Table 1 and Table 2 respectively.

After being informed about the related therapeutic maneuver, the patients were chosen for the sequence of endoscopic procedures and LC. And, the unsuccessful patients underwent through the OC with CBD exploration along with choledochoscopy. General anesthesia with nasal endotracheal intubation was done in all the patients. Antibiotic prophylaxis was given according to the standard recommendation for cholecystectomy.18 The ERCP procedure was performed with the patients in the prone position. A duodenoscope (TJF160R, Fujinon, Japan) was inserted into the second segment of duodenum via the mouth. A cholangiogram was carried out using C-arm X-ray (SIEMENS) and an EST was performed to extract the CBD stones. The stones were removed by basket or balloon catheter. Stones larger than 10 mm were removed using a mechanical lithotripter. Following ERCP, care was taken to remove all the gas from the stomach to facilitate LC. The patients were then placed in the reverse Trendelenburg position. LC was performed using the four trocar technique. A sub-hepatic drain was positioned if there was any concern about the possible bile leakage or bleeding in the postoperative period.

In cases of failed ERCP, the patients were placed in the supine position and OC with CBD explorations were performed in the same setting. A right subcostal incision was given for the open surgery. Cholecystectomy was performed ante-grade or retro-grade technique depending upon the anatomical variations of the gallbladder. CBD was opened below the opening of the cystic duct and stone clearances were done. To assure the stone clearances intraoperative choledochoscopies were performed. All the procedure viz. ERCP, LC, and open surgeries were performed by an experienced single surgeon and his team.

The statistical data were analyzed with a t-test, Pearson's χ2, Fisher's exact test, Mann Whitney's test, and Kruskal Wallis test using a statistical analysis program (SPSS 16), p <0.05 was considered statistically significant.

Study Design

Study Type:

Observational

Actual Enrollment :

160 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

"Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis: A Prospective Study in a Peripheral-Level Hospital"

Actual Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
ERCP+LC Patients in this group underwent 2-stage ERCP+LC in a single setting. And, it was compared with our control group	Procedure: ERCP+LC Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.
OC+CBD This group with 2-stage OC+CBD exploration in a single setting approach was taken as a control group.	Procedure: OC+CBD Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.

Arm

Intervention/Treatment

ERCP+LC

Patients in this group underwent 2-stage ERCP+LC in a single setting. And, it was compared with our control group

Procedure: ERCP+LC

Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.

OC+CBD

This group with 2-stage OC+CBD exploration in a single setting approach was taken as a control group.

Procedure: OC+CBD

Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.

Outcome Measures

Primary Outcome Measures

Compare ERCP+LC with OC+CBD exploration [7 days]
To compare the single setting ERCP+LC with OC+CBD exploration and the Feasibility of the procedure at the peripheral setting hospital.

Secondary Outcome Measures

Morbidity [7 days]
Detect cholangitis, pancreatitis, abdominal collection, and wound infection respectively
Length [7 days]
The length of Hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All the sonological proven cases of choledocholithiasis with cholelithiasis.
CBD diameter <2cm.
Age >13 yrs.

Exclusion Criteria:

Clinical, radiologic, or biochemical evidence of cholangitis and pancreatitis.
Evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, neoplasm, Suppurative or necrotizing cholecystitis, gall bladder empyema, or perforation, Pregnancy.

Age >85 yrs.