Choledochotomy Techniques During LCBDE

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Choledocholithiasis

Intervention / Treatment
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* Procedure: choledochotomy techniques during LCBDE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>sharp choledochotomy by a scalpel or scissor | Procedure: choledochotomy techniques during LCBDE<br> <br> |
| Group 2<br>choledochotomy by a diathermy hook | Procedure: choledochotomy techniques during LCBDE<br> <br> |
| Group 3<br>choledochotomy by an ultrasonic device | Procedure: choledochotomy techniques during LCBDE<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choledochotomy technique, CBD stones, choledocholithiasis