To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients undergoing staging laparoscopy without intent of curative resection in the same sitting.

malignancies other than adenocarcinoma

Final histopathology is benign

Trial population

All patients of perihilar and hilar cholangiocarcinoma, carcinoma gall bladder, hepatocellular carcinoma, periampullary malignancies and intrahepatic cholangiocarcinoma undergoing staging laparoscopy before surgery for curative intent

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention

    Other intervention

    NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY

Treatment groups

350 Participants
are divided into 5 treatment groups
Group A: carcinoma gall bladder1 intervention
Group B: Hepatocellular carcinoma1 intervention
Group C: Perihilar and hilar cholangiocarcinoma1 intervention
Group D: Peri-ampullary Malignancy1 intervention
Group E: Intrahepatic cholangiocarcinoma1 intervention

Trial outcomes

Primary outcomes

1

the yield of staging laparoscopy in HPB malignancies

proportion of patients with positive staging laparoscopy (Metastatic disease/unresectable) findings leading to abandonement of procedure

Time frame
DAY 0

Secondary outcomes

1

Positive findings on SL leading to abandonment

findings like peritoneal/liver/omental nodules which are postive on frozen section proving metastatic disease

Time frame
DAY 0
2

False positive findings

findings like peritoneal/liver/omental nodules which are negative on frozen section

Time frame
DAY 0
3

Additional findings reported on laparotomy after SL

finding of nodules/metastatis on laparotomy which are not detected on staging laparoscopy

Time frame
DAY 0

Other outcomes

Sponsors and contacts

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