Actively Recruiting

Age: 18Years +
All Genders
NCT07480005

To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies

Led by Institute of Liver and Biliary Sciences, India · Updated on 2026-03-23

350

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients with suspected HPB malignancies undergoing staging laparoscopy before proceeding to laparotomy
  • Pre-operative CT scans with cut size less than or equal to 1.5 mm
Not Eligible

You will not qualify if you...

  • Patients undergoing staging laparoscopy without intent of curative resection in the same sitting
  • Malignancies other than adenocarcinoma
  • Final histopathology shows benign disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India, 110070

Actively Recruiting

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Research Team

R

Rahul Shivhare, MS

CONTACT

R

Ragini Kilambi, Mch

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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