Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:17 AM
Study NCT ID:
NCT07480005
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the yield of staging laparoscopy in HPB malignancies', 'timeFrame': 'DAY 0', 'description': 'proportion of patients with positive staging laparoscopy (Metastatic disease/unresectable) findings leading to abandonement of procedure'}], 'secondaryOutcomes': [{'measure': 'Positive findings on SL leading to abandonment', 'timeFrame': 'DAY 0', 'description': 'findings like peritoneal/liver/omental nodules which are postive on frozen section proving metastatic disease'}, {'measure': 'False positive findings', 'timeFrame': 'DAY 0', 'description': 'findings like peritoneal/liver/omental nodules which are negative on frozen section'}, {'measure': 'Additional findings reported on laparotomy after SL', 'timeFrame': 'DAY 0', 'description': 'finding of nodules/metastatis on laparotomy which are not detected on staging laparoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPB Malignancies']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nSubgroup 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.\n\nFindings 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nAll patients with suspected HPB malignancies undergoing staging laparoscopy before proceeding to laparotomy.\n\nPre-op CT scans of cut size less than or equal to 1.5 mm\n\nExclusion Criteria:\n\n1. Patients undergoing staging laparoscopy without intent of curative resection in the same sitting.\n2. malignancies other than adenocarcinoma\n3. Final histopathology is benign'}, 'identificationModule': {'nctId': 'NCT07480005', 'briefTitle': 'To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies', 'orgStudyIdInfo': {'id': 'ILBS-HPBMALIGNANCY-O1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'carcinoma gall bladder', 'description': 'suspected CaGb patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma of gall bladder', 'interventionNames': ['Other: No intervention']}, {'label': 'Hepatocellular carcinoma', 'description': 'suspected HCC patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of HCC', 'interventionNames': ['Other: No intervention']}, {'label': 'Perihilar and hilar cholangiocarcinoma', 'description': 'suspected Perihilar and hilar cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma', 'interventionNames': ['Other: No intervention']}, {'label': 'Peri-ampullary Malignancy', 'description': 'suspected Peri-ampullary Malignancy patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma', 'interventionNames': ['Other: No intervention']}, {'label': 'Intrahepatic cholangiocarcinoma', 'description': 'suspected Intrahepatic cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY', 'armGroupLabels': ['Hepatocellular carcinoma', 'Intrahepatic cholangiocarcinoma', 'Peri-ampullary Malignancy', 'Perihilar and hilar cholangiocarcinoma', 'carcinoma gall bladder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Rahul shivhare, MS', 'role': 'CONTACT', 'email': 'rahulshivhare93@gmail.com', 'phone': '01143600000'}], 'facility': 'Institute of Liver and Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Rahul Shivhare, MS', 'role': 'CONTACT', 'email': 'rahulshivhare93@gmail.com', 'phone': '01146300000'}, {'name': 'Ragini Kilambi, Mch', 'role': 'CONTACT', 'email': 'ragini.kilambi@gmail.com', 'phone': '01146300000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}