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NCT07480005

To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies

Recruiting now Last updated 23 March 2026
What this trial tests

trial testing No intervention in HPB Malignancies in 350 participants. Currently enrolling.

Timeline
18 March 2026
Primary endpoint
30 October 2026
30 October 2026

Quick facts

Lead sponsorInstitute of Liver and Biliary Sciences, India
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment350
Start date18 March 2026
Primary completion30 October 2026
Estimated completion30 October 2026
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

18 and older, any sex, with HPB Malignancies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research project, to be conducted at the Institute of Liver \& Biliary Sciences, aims to evaluate the effectiveness of staging laparoscopy (SL) in detecting occult metastases in hepatopancreatobiliary (HPB) malignancies in the current era of advanced imaging modalities such as MDCT, MRI, EUS, and PET-CT. While SL is a minimally invasive technique that aids in identifying radiologically undetectable metastases, its utility in routine practice is under scrutiny due to improved imaging accuracy. The study is premised on the hypothesis that the yield of SL is low in the current imaging era, questioning its routine application. The study uses an ambispective cohort design and includes all patients undergoing SL for HPB malignancies from January 2012 to March 2026 at ILBS, Delhi. The primary objective is to assess the yield of SL, while secondary objectives include evaluating false positives/negatives, the added value of PET-CT over CT, and identifying clinical or radiological predictors of positive SL. Subgroup analyses will be performed for different HPB cancers including periampullary malignancies, gallbladder cancer, hilarcholangiocarcinoma, intrahepatic cholangiocarcinoma, pancreatic ductal adenocarcinoma, and hepatocellular carcinoma. Data collection includes demographics, tumor markers, imaging findings, SL results, duration, and associated costs. Findings from this study could inform refined criteria for the selective use of SL, avoiding unnecessary surgeries and optimizing resource utilization. This could lead to evidence-based guidelines for staging practices in HPB cancers, balancing clinical benefits against costs and surgical risks in the context of modern diagnostic capabilities.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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