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To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies

NCT07480005 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2026-03-23

No results posted yet for this study

Summary

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.

Conditions

  • HPB Malignancies

Interventions

OTHER

No intervention

NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2026-10-30
Completion
2026-10-30

Countries

  • India

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 NCT07480005 on ClinicalTrials.gov