Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2026-03-27 @ 9:53 AM
Study NCT ID:
NCT02871804
Status:
UNKNOWN
Last Update Posted:
2016-08-18
First Post:
2016-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 304}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-08-15', 'lastUpdatePostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of pancreatic fsitula grade B/C', 'timeFrame': '6 months after operation'}], 'secondaryOutcomes': [{'measure': 'the incidence of pancreatic fsitula of all grades', 'timeFrame': '6 months after operation'}, {'measure': 'the incidence of pancreatic fsitula grade C', 'timeFrame': '6 months after operation'}, {'measure': 'the incidenceof intra-abdominal haemorrhage', 'timeFrame': '6 months after operation'}, {'measure': 'the incidence of all complications', 'timeFrame': '6 months after operation'}, {'measure': 'comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C', 'timeFrame': '6 months after operation'}, {'measure': 'mortality', 'timeFrame': '6 months after operation'}, {'measure': 'the incidence of thrombosis of the splenic vein', 'timeFrame': '6 months after operation'}, {'measure': 'the operative time', 'timeFrame': 'during operation'}, {'measure': 'volume of blood loss', 'timeFrame': 'during operation'}, {'measure': 'thickness of the resected pancreatic parenchyma', 'timeFrame': 'during operation'}, {'measure': 'haemostasis of the staple line', 'timeFrame': 'during operation'}, {'measure': 'integrity of the staple line', 'timeFrame': 'during operation'}, {'measure': 'the incidence of pancreatic injury', 'timeFrame': 'during operation'}, {'measure': 'need for additional sutures to securely close the pancreatic stump', 'timeFrame': 'during operation'}, {'measure': 'time needed for pancreatic transection', 'timeFrame': 'during operation'}, {'measure': 'duration of drainage tube placement', 'timeFrame': '6 months after operation'}, {'measure': 'postoperative hospital stay duration', 'timeFrame': '6 months after operation'}, {'measure': 'the incidence of conversion from laparoscopic surgery to open surgery', 'timeFrame': 'during operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '33656542', 'type': 'DERIVED', 'citation': 'Yamada S, Fujii T, Sonohara F, Kawai M, Shibuya K, Matsumoto I, Fukuzawa K, Baba H, Aoki T, Unno M, Satoi S, Kishi Y, Hatano E, Uemura K, Horiguchi A, Sho M, Takeda Y, Shimokawa T, Kodera Y, Yamaue H. Safety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):418-428. doi: 10.1001/jamasurg.2021.0108.'}, {'pmid': '29996884', 'type': 'DERIVED', 'citation': 'Yamada S, Fujii T, Kawai M, Shimokawa T, Nakamura M, Murakami Y, Satoi S, Eguchi H, Nagakawa Y, Kodera Y, Yamaue H. Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial. Trials. 2018 Jul 11;19(1):369. doi: 10.1186/s13063-018-2756-7.'}]}, 'descriptionModule': {'briefSummary': 'Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).', 'detailedDescription': 'In distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. This procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of this trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during distal pancreatectomy using a mechanical stapler.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail\n* ECOG Performance Status (PS) = 0-1\n* Age ≥ 20 years old\n* Maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.) (a) White blood cells ≥ 2,500/mm3 (b) Haemoglobin ≥ 9.0 g/dL (c) platelets ≥ 100,000/mm3 (d) Total bilirubin ≤ 2.0 mg/dL (e) Creatinine ≤ 2.0 mg/dL (v) Sufficient judgement to understand the study and to provide written informed consent\n\nExclusion Criteria:\n\n* Splenic vein-preserving distal pancreatectomy\n* Superior mesenteric vein or portal vein invasion\n* Pancreatic trauma\n* Preoperative inflammatory pancreatic disease (pancreatitis)\n* Requirement of anti-coagulant treatment during or after surgery. Anti-coagulant treatment at 24 hrs after surgery is allowed.\n* Severe ischemic cardiovascular disease\n* Liver cirrhosis or active hepatitis\n* Need for oxygen due to interstitial pneumonia or lung fibrosis\n* Dialysis due to chronic renal failure\n* Need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder\n* Active multiple cancer that is thought to influence the occurrence of adverse events\n* Difficulty with study participation due to psychotic disease or symptoms\n* Inappropriate use of the stapler\n* Inappropriate for the study objectives'}, 'identificationModule': {'nctId': 'NCT02871804', 'acronym': 'COSMOS-DP', 'briefTitle': 'Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Wakayama Medical University'}, 'officialTitle': 'Comparison of Resection During Distal Pancreatectomy of the Splenic Vein Either Together With the Pancreatic Parenchyma or After Isolation: A Multicentre, Prospective, Randomized Phase III Trial', 'orgStudyIdInfo': {'id': 'COSMOS-DP trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'separated resection of the splenic vein', 'description': 'separated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.', 'interventionNames': ['Procedure: separated resection of the splenic vein']}, {'type': 'EXPERIMENTAL', 'label': 'combined resection of the splenic vein', 'description': 'combined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.', 'interventionNames': ['Procedure: combined resection of the splenic vein']}], 'interventions': [{'name': 'combined resection of the splenic vein', 'type': 'PROCEDURE', 'description': 'combined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.', 'armGroupLabels': ['combined resection of the splenic vein']}, {'name': 'separated resection of the splenic vein', 'type': 'PROCEDURE', 'description': 'separated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.', 'armGroupLabels': ['separated resection of the splenic vein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641-8510', 'city': 'Wakayama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroki Yamaue, MD, PhD', 'role': 'CONTACT', 'email': 'yamaue-h@wakayama-med.ac.jp', 'phone': '+81-73-441-0613'}, {'name': 'Tsutomu Fujii, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manabu Kawai, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suguru Yamada, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yuichi Nagakawa, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sohei Satoi, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hidetoshi Eguchi, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yoshiaki Murakami, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Masafumi Nakamura, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Toshio Shimokawa, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Wakayama Medical University', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'centralContacts': [{'name': 'Hiroki Yamaue, MD, PhD', 'role': 'CONTACT', 'email': 'yamaue-h@wakayama-med.ac.jp', 'phone': '+81-73-441-0613'}], 'overallOfficials': [{'name': 'Hiroki Yamaue, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wakayama Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wakayama Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hiroki Yamaue', 'investigatorAffiliation': 'Wakayama Medical University'}}}}