Choledochotomy Techniques During LCBDE

Impact of Choledochotomy Techniques During Laparoscopic CBD Exploration on Short- and Long-term Clinical Outcomes: Time to Change Concepts

complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.

Study Overview

• Status: Completed
• Conditions: Choledocholithiasis
• Intervention / Treatment: Procedure: choledochotomy techniques during LCBDE

Detailed Description

Background: complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.

Methods: from March 2014 to February 2018, 85 patients with choledocholithiasis (52 females and 33 males) were enrolled in this study. These patients were treated by LCBDE using various choledochotomy techniques, including scalpel or scissor (28 patients, 33%) in group I, using diathermy hook (35 patients, 41%) in group II, or using an ultrasonic device (22 patients, 26 %) in group III. Postoperative follow-up was done for assessment of all possible complications either early (within 3-6 months postoperatively), or late (2-6 years postoperatively) with meticulous observation and study of any relevant postoperative event.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

During the study period, 85 patients (52 females and 33 males) were enrolled in this study which they were complaining of manifestations of CBD stones and treated using laparoscopic approaches, using various choledochotomy techniques.

Description

Inclusion Criteria:

• All adult patients with choledocholithiasis who underwent LCBDE combined with LC were enrolled in this study. No limitations as regards the stone sizes or numbers were considered. The CBD diameter should be at least ± 1 cm.

Exclusion Criteria:

• Exclusion criteria were normal caliber or stenosed CBD, or the presence of overt cholangitis. Additionally, treated patients with the trans-cystic approach for stone extraction were excluded from this study.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; sharp choledochotomy by a scalpel or scissor	Procedure: choledochotomy techniques during LCBDE
Group 2; choledochotomy by a diathermy hook	Procedure: choledochotomy techniques during LCBDE
Group 3; choledochotomy by an ultrasonic device	Procedure: choledochotomy techniques during LCBDE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biliary leakage/fistula	According to the international study group of liver surgery, bile leakage is defined as fluid with an elevated bilirubin level (3 times higher than the serum bilirubin measured at the same time) in the abdominal drain or the intra-abdominal fluid on or after POD 3, or as the need for radiologic intervention because of biliary collections or re-laparotomy resulting from biliary peritonitis	first postoperative 6 months up to 6 years postoperatively
biliary stricture	The biliary stricture is known as abnormal narrowing of the bile duct associated with the rising of cholestasis indexes. Additionally, it has required an invasive treatment such as ERCP, percutaneous transhepatic drainage, or re-surgery [16]. Biliary complications were diagnosed by trans-tubal cholangiography or through MRCP and could be managed conservatively, ERCP, if there is an accessible route, PTD or surgical intervention.	2-6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	from incision to closure	from incision to closure
intraoperative bleeding	in mm	during surgery
conversion rate	from laparoscopy to open	during surgery
jaundice	missed stone	2-6 years
wound sepsis	infection of the wound	2-6 years
cholangitis	inflammation of the biliary system	2-6 years
wound dehiscence	Gapped wound	2-6 years
Peritoneal sepsis and abscess	peritonitis	first postoperative 6 months
Recurrent stones	recurrence	2-6 years

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Emad Ali Ahmed, MD, PhD, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: choledocholithiasis; choledochotomy technique; CBD stones
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Choledocholithiasis
• Other Study ID Numbers: 22/05/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes