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

December 27, 2019 updated by: NabinPokharel, Lumbini Medical College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 81 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study was carried out in a peripheral setting hospital located in a remote city of Nepal-"Palpa" and the population is heterogeneous in terms of age.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Age >85 yrs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare ERCP+LC with OC+CBD exploration
Time Frame: 7 days
To compare the single setting ERCP+LC with OC+CBD exploration and the Feasibility of the procedure at the peripheral setting hospital.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 7 days
Detect cholangitis, pancreatitis, abdominal collection, and wound infection respectively
7 days
Length
Time Frame: 7 days
The length of Hospital stay
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumbini Medical College

Investigators

  • Study Chair: Chet R Pant, MD, MPH, Lumbini Medical College & Teaching Hospital Ltd, Kathmandu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 27, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRC-LMC 01-H-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We can share our study IPD to interested researchers. Please email us at nabin.pokharel@gmail.com

IPD Sharing Time Frame

Data will be available for all interested researchers via the publication.

IPD Sharing Access Criteria

interested researchers in the field of ERCP; Laparoscopic Cholecystectomy; Open Cholecystectomy, Laparoscopic CBD Exploration, Open CBD Exploration.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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