Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Location status: Recruiting
NCT Number: NCT07480005
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
New Delhi, National Capital Territory of Delhi, 110070, India
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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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
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
Time frame: DAY 0
proportion of patients with positive staging laparoscopy (Metastatic disease/unresectable) findings leading to abandonement of procedure
Time frame: DAY 0
findings like peritoneal/liver/omental nodules which are postive on frozen section proving metastatic disease
Time frame: DAY 0
findings like peritoneal/liver/omental nodules which are negative on frozen section
Time frame: DAY 0
finding of nodules/metastatis on laparotomy which are not detected on staging laparoscopy
Contact information is provided by the study sponsor or research team.
Ragini Kilambi, Mch
CONTACT
Rahul Shivhare, MS
CONTACT
Institute of Liver and Biliary Sciences, India
Other
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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.