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Completed

NCT Number: NCT04463381

Choledochotomy Techniques During LCBDE

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.

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Key information

Conditions

Choledocholithiasis Bile Duct Diseases Biliary Tract Diseases Cholelithiasis Common Bile Duct Diseases Digestive System Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University

Sohag, 82524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

choledochotomy techniques during LCBDE

Procedure

Primary outcomes

  1. biliary leakage/fistula

    Time frame: first postoperative 6 months up to 6 years postoperatively

    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

  2. biliary stricture

    Time frame: 2-6 years

    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.

Secondary outcomes

  1. operative time

    Time frame: from incision to closure

    from incision to closure

  2. intraoperative bleeding

    Time frame: during surgery

    in mm

  3. conversion rate

    Time frame: during surgery

    from laparoscopy to open

  4. jaundice

    Time frame: 2-6 years

    missed stone

  5. wound sepsis

    Time frame: 2-6 years

    infection of the wound

  6. cholangitis

    Time frame: 2-6 years

    inflammation of the biliary system

  7. wound dehiscence

    Time frame: 2-6 years

    Gapped wound

  8. Peritoneal sepsis and abscess

    Time frame: first postoperative 6 months

    peritonitis

  9. Recurrent stones

    Time frame: 2-6 years

    recurrence

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Jul 9, 2020
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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