HPB Malignancies
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the yield of staging laparoscopy in HPB malignancies | DAY 0 | proportion of patients with positive staging laparoscopy (Metastatic disease/unresectable) findings leading to abandonement of procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive findings on SL leading to abandonment | DAY 0 | findings like peritoneal/liver/omental nodules which are postive on frozen section proving metastatic disease |
| False positive findings | DAY 0 | findings like peritoneal/liver/omental nodules which are negative on frozen section |
| Additional findings reported on laparotomy after SL | DAY 0 | finding of nodules/metastatis on laparotomy which are not detected on staging laparoscopy |
Countries
India
Contacts
CONTACTRahul Shivhare, MS
CONTACTRagini Kilambi, Mch
Outcome results
None listed