Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-13 @ 6:20 PM
Study NCT ID:
NCT02799212
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D001201', 'term': 'Ascites'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2016-06-09', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of postoperative ascites during the postoperative course', 'timeFrame': 'Day 90', 'description': 'The presence of postoperative ascites during the postoperative course defined by:\n\n* ≥500 ml / 24h of fluid in the drains during at least 3 days. Or\n* ascites requiring puncture or drainage'}], 'secondaryOutcomes': [{'measure': 'Duration of ascites', 'timeFrame': 'Day 90', 'description': 'Number of days with ≥ 500ml / 24h of ascites'}, {'measure': 'Volume of ascites', 'timeFrame': 'Day 90', 'description': 'Total ascites volume'}, {'measure': 'postoperative morbidity', 'timeFrame': 'Day 90', 'description': 'Postoperative morbidity according to Dindo-Clavien'}, {'measure': 'Postoperative morbidity on Liver failure', 'timeFrame': 'Day 90', 'description': 'Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)'}, {'measure': 'Postoperative morbidity on Renal failure', 'timeFrame': 'Day 90', 'description': 'Presence and severity of renal failure according to RIFLE scale (RIFLE: Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Hepatectomy', 'Ascites', 'Somatostatin'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '30139340', 'type': 'BACKGROUND', 'citation': 'Mohkam K, Rayar M, Adam JP, Muscari F, Rode A, Merle P, Pradat P, Bauler S, Delfour I, Chiche L, Ducerf C, Boudjema K, Lesurtel M, Laurent C, Mabrut JY. Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT). BMC Cancer. 2018 Aug 23;18(1):844. doi: 10.1186/s12885-018-4667-0.'}]}, 'descriptionModule': {'briefSummary': 'Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with HCC diagnosed by histology or by imaging findings according to the Barcelona Clinic Liver Cancer Group\n* Patients with a single or multiple HCCs deemed to be resectable with a curative intent at the preoperative evaluation\n* Patients for whom an indication for hepatectomy has been decided and approved by multidisciplinary board:\n* by laparotomy\n* by coelioscopy with resection of at least 2 liver segments\n* Patients with any underlying liver disease with or without proven cirrhosis, regarding histological features (including F2-F3-F4 fibrosis with or without cirrhosis) or with other evidence of a diseased liver if no biopsy has been performed preoperatively (dysmorphic liver or evidence of portal hypertension at imaging findings, oesophageal varices at endoscopy)\n* Age ≥ 18 years\n* Patients with ability to understand and sign a written inform consent form\n* Patients who will be available for follow-up\n\nExclusion Criteria:\n\n* Patients participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (except interventional research with minimal risks and constraints that do not interfere with the judgement criteria of the study according to the judgement of the coordinating investigator).\n* Patients with evidence of a healthy liver at biopsy\n\nDisease-associated non-inclusion criteria include:\n\n* Another histologic type of hepatic tumor besides HCC\n* Distant extra-hepatic metastases, including peritoneal carcinomatosis\n* The existence of complete portal thrombosis of the main portal trunk\n\nOperative technique-associated non-inclusion criteria include:\n\n\\- Indication of coelioscopy with resection of less than 2 liver segments'}, 'identificationModule': {'nctId': 'NCT02799212', 'acronym': 'SOMAPROTECT01', 'briefTitle': 'Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)', 'orgStudyIdInfo': {'id': '69HCL16_0129'}, 'secondaryIdInfos': [{'id': '2016-004230-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day', 'interventionNames': ['Drug: somatostatin infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo infusion (50ml of 0.9% NaCl/day) during 6 days', 'interventionNames': ['Drug: placebo infusion']}], 'interventions': [{'name': 'somatostatin infusion', 'type': 'DRUG', 'description': 'postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.', 'armGroupLabels': ['Experimental group']}, {'name': 'placebo infusion', 'type': 'DRUG', 'description': 'Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clichy', 'country': 'France', 'facility': 'APHP - Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille - Hopital Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'APHM - Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Pessac', 'country': 'France', 'facility': 'CHU de Bordeaux - Hôpital Haut Lévèque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse - Hopital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}