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Recruiting

NCT Number: NCT07480005

To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver and Biliary Sciences

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

Location status: Recruiting

Location contact

Rahul shivhare, MS

CONTACT

[email protected]

01143600000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

No intervention

Other

NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY

Primary outcomes

  1. the yield of staging laparoscopy in HPB malignancies

    Time frame: DAY 0

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

Secondary outcomes

  1. Positive findings on SL leading to abandonment

    Time frame: DAY 0

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

  2. False positive findings

    Time frame: DAY 0

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

  3. Additional findings reported on laparotomy after SL

    Time frame: DAY 0

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ragini Kilambi, Mch

CONTACT

[email protected]

01146300000

Rahul Shivhare, MS

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.