An observational study in HPB Malignancies, sponsored by Institute of Liver and Biliary Sciences, India. Recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Institute of Liver and Biliary Sciences, India · Observational
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.
Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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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:
suspected CaGb patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma of gall bladder
Other: No intervention
suspected HCC patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of HCC
Other: No intervention
suspected Perihilar and hilar cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma
Other: No intervention
suspected Peri-ampullary Malignancy patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma
Other: No intervention
suspected Intrahepatic cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma
Other: No intervention
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
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
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
False positive findings
findings like peritoneal/liver/omental nodules which are negative on frozen section
Time frame: DAY 0
Additional findings reported on laparotomy after SL
finding of nodules/metastatis on laparotomy which are not detected on staging laparoscopy
Time frame: DAY 0
Plan to share: Undecided
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Institute of Liver and Biliary Sciences, India