NCT07480005 To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies
| NCT ID | NCT07480005 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Condition | HPB Malignancies |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2026-03-18 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07480005 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HPB Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07480005 currently recruiting?
Yes, NCT07480005 is actively recruiting participants. Contact the research team at rahulshivhare93@gmail.com for enrollment information.
Where is the NCT07480005 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT07480005 clinical trial?
NCT07480005 is sponsored by Institute of Liver and Biliary Sciences, India. The trial plans to enroll 350 participants.