Choledochotomy Techniques During LCBDE

Choledocholithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463381
• Other study ID #: 22/05/2020
• Status: Completed
• Start date: March 1, 2014
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2020
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 1, 2020
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Choledocholithiasis

Intervention

Procedure:
• choledochotomy techniques during LCBDE

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

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