Gallbladder Infundibulum as a Guide for Ductal Identification.

NCT06239233 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 196

Last updated 2024-02-02

No results posted yet for this study

Summary

Introduction: Bile duct injury (BDI) is a catastrophic complication of cholecystectomy, and misidentification of the cystic anatomy is considered to be the main cause. Although several techniques have been developed to prevent BDI, such as the "critical view of safety", the infundibular technique, the rates remain higher during laparoscopic cholecystectomy (LC) than during open surgery. Strategy for ductal identification during laparoscopic cholecystectomy can help to prevent laparoscopic bile duct injury.

Methods: A prospective study of 196 patients who will undergo LC during the study period of one year at Nepal Mediciti Hospital will be conducted. The gallbladder infundibulum will be classified by its position located on an imaginary clock with the gallbladder neck as the center point of the dial, 3 o'clock position as cranial, 6 o'clock as dorsal, 9 o'clock as caudal, and 12 o'clock as ventral, as well as the axial position. Patient demographics, pathologic variables and infundibulum classification will be evaluated. Detailed analysis of ductal identification based on gallbladder infundibulum position will be performed in this study. All infundibulum positions will be recorded during intraoperative laparoscopic procedure.

Conditions

  • Gallstone Disease

Interventions

PROCEDURE

Laparoscopic cholecystectomy

The surgeon makes small incisions in the abdominal wall, usually around the navel. Trocars (hollow tubes) are inserted through these incisions to provide access for the laparoscope and specialized instruments. A laparoscope, a thin tube with a light and camera, is inserted through one of the trocars. It allows the surgical team to visualize the abdominal cavity on a monitor. The surgeon carefully identifies the gallbladder and the cystic duct, which connects the gallbladder to the common bile duct. The cystic duct and artery are clipped and cut to disconnect the gallbladder from the biliary system. This step ensures the safe removal of the gallbladder. The surgeon gently detaches the gallbladder from the liver bed and removes it through one of the small incisions. Any bleeding vessels are sealed, and the small incisions are closed with stitches or surgical glue.

Sponsors & Collaborators

  • Nepal Mediciti Hospital

    lead OTHER

Principal Investigators

  • Rajiv Mishra, M.S. · Nepal Mediciti Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-25
Primary Completion
2024-10-19
Completion
2024-10-19

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06239233 on ClinicalTrials.gov