To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies

Institute of Liver and Biliary Sciences, India

Status: Enrolling

Conditions: HPB Malignancies

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07480005

ILBS-HPBMALIGNANCY-O1

Details and patient eligibility

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-

All patients with suspected HPB malignancies undergoing staging laparoscopy before proceeding to laparotomy.

Pre-op CT scans of cut size less than or equal to 1.5 mm

Exclusion criteria

1. Patients undergoing staging laparoscopy without intent of curative resection in the same sitting.
2. malignancies other than adenocarcinoma
3. Final histopathology is benign

Trial design

350 participants in 5 patient groups

carcinoma gall bladder

Description:

suspected CaGb patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma of gall bladder

Treatment:

Other: No intervention

Hepatocellular carcinoma

Description:

suspected HCC patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of HCC

Treatment:

Other: No intervention

Perihilar and hilar cholangiocarcinoma

Description:

suspected Perihilar and hilar cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma

Treatment:

Other: No intervention

Peri-ampullary Malignancy

Description:

suspected Peri-ampullary Malignancy patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma

Treatment:

Other: No intervention

Intrahepatic cholangiocarcinoma

Description:

suspected Intrahepatic cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma

Treatment:

Other: No intervention