Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
Study NCT ID:
NCT03770559
Status:
UNKNOWN
Last Update Posted:
2022-05-20
First Post:
2018-11-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Therapeutic Evaluation(Both Short-term and Long-term Outcome) of Minimal Invasive Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer Patients
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The development of study model was divided into 2 parrallel groups( Minimal Invasive RAMPS vs. Open RAMPS) based on the certain surgical procedure underwent'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2018-11-24', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posteroperative length of stay', 'timeFrame': 'Until patients were discharged', 'description': 'The days between the postoperative day-1 to the date when patient was eligible to be discharged.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'more than 1 year', 'description': 'DFS means the survival duration after surgery.'}, {'measure': 'Operative time', 'timeFrame': 'during the surgery', 'description': 'Durtion of operation'}, {'measure': 'Estimated blood loss', 'timeFrame': 'During the surgery', 'description': 'blood loss volume during the operation'}, {'measure': 'Postoperative pain', 'timeFrame': 'Until patients were discharged', 'description': 'VAS score to measure the degree of postoperative pain'}, {'measure': 'III-IV grade postoperative complication rate', 'timeFrame': 'No less than 3 months.', 'description': 'The ratio between patients with complication(s) and total patients in each groups.'}, {'measure': 'Disease Free Survival', 'timeFrame': 'more than 1 year', 'description': 'DFS means the survival duration after surgery without any evidence of recurrence and metastasis.'}, {'measure': 'R0 resection', 'timeFrame': 'up to approximately 2 weeks', 'description': 'the margin status of resection specimen'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radical Antegrade Modular Pancreatosplenectomy(RAMPS)', 'Pancreatic Cancer', 'Minimal Invasive', 'ERAS', 'Disease Free Survival'], 'conditions': ['Pancreatic Cancer', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '8813262', 'type': 'BACKGROUND', 'citation': 'Harrison LE, Klimstra DS, Brennan MF. Isolated portal vein involvement in pancreatic adenocarcinoma. A contraindication for resection? Ann Surg. 1996 Sep;224(3):342-7; discussion 347-9. doi: 10.1097/00000658-199609000-00010.'}, {'pmid': '10768705', 'type': 'BACKGROUND', 'citation': 'Jimenez RE, Warshaw AL, Rattner DW, Willett CG, McGrath D, Fernandez-del Castillo C. Impact of laparoscopic staging in the treatment of pancreatic cancer. Arch Surg. 2000 Apr;135(4):409-14; discussion 414-5. doi: 10.1001/archsurg.135.4.409.'}, {'pmid': '22192922', 'type': 'BACKGROUND', 'citation': 'Mitchem JB, Hamilton N, Gao F, Hawkins WG, Linehan DC, Strasberg SM. Long-term results of resection of adenocarcinoma of the body and tail of the pancreas using radical antegrade modular pancreatosplenectomy procedure. J Am Coll Surg. 2012 Jan;214(1):46-52. doi: 10.1016/j.jamcollsurg.2011.10.008.'}, {'pmid': '28409377', 'type': 'BACKGROUND', 'citation': 'Ome Y, Hashida K, Yokota M, Nagahisa Y, Michio O, Kawamoto K. Laparoscopic radical antegrade modular pancreatosplenectomy for left-sided pancreatic cancer using the ligament of Treitz approach. Surg Endosc. 2017 Nov;31(11):4836-4837. doi: 10.1007/s00464-017-5561-6. Epub 2017 Apr 13.'}, {'pmid': '28583142', 'type': 'BACKGROUND', 'citation': 'Cao F, Li J, Li A, Li F. Radical antegrade modular pancreatosplenectomy versus standard procedure in the treatment of left-sided pancreatic cancer: A systemic review and meta-analysis. BMC Surg. 2017 Jun 5;17(1):67. doi: 10.1186/s12893-017-0259-1.'}, {'pmid': '17254928', 'type': 'BACKGROUND', 'citation': 'Strasberg SM, Linehan DC, Hawkins WG. Radical antegrade modular pancreatosplenectomy procedure for adenocarcinoma of the body and tail of the pancreas: ability to obtain negative tangential margins. J Am Coll Surg. 2007 Feb;204(2):244-9. doi: 10.1016/j.jamcollsurg.2006.11.002. Epub 2007 Jan 4.'}, {'pmid': '24166024', 'type': 'BACKGROUND', 'citation': 'Park HJ, You DD, Choi DW, Heo JS, Choi SH. Role of radical antegrade modular pancreatosplenectomy for adenocarcinoma of the body and tail of the pancreas. World J Surg. 2014 Jan;38(1):186-93. doi: 10.1007/s00268-013-2254-8.'}, {'pmid': '36185308', 'type': 'DERIVED', 'citation': 'Dai M, Zhang H, Yang Y, Xiu D, Peng B, Sun B, Cao F, Wu Z, Wang L, Yuan C, Chen H, Wang Z, Tian X, Wang H, Liu W, Xu J, Liu Q, Zhao Y. The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol. Front Oncol. 2022 Sep 15;12:965508. doi: 10.3389/fonc.2022.965508. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Pancreatic cancer is regarded as "the king of cancer". It is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Radical antegrade modular pancreatosplenectomy (RAMPS) is a standard method for treating pancreatic cancer at the body and tail of pancreas. In the same surgical approach, the investigators are going to compare and discuss the advantages of laparoscopic and open RAMPS in the RCT study.', 'detailedDescription': 'Open RAMPS is widely used now to treat pancreatic cancer at the body and tail of pancreas. Meanwhile, laparoscopic surgery is proved to have many advantages in other operations. According to primary retrospective study of open and laparoscopic RAMPS, there was no statistically significant difference in the long-term follow-up situations between these two groups, indicating the safety of both this two surgical approaches. The investigators would like to promote a prospective RCT study, to give more evidences of the superiority of laparoscopic RAMPS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years old and older;\n2. Pathology diagnosed as pancreatic adenocarcinoma or suspect cancer mass at the pancreatic body or tail;\n3. Patients who are eligible and planned to be performed RAMPS procedure;\n4. Resectable or borderline resectable tumor by preoperative evaluation.\n\nExclusion Criteria:\n\n1. Patients with evidence of distant metastasis or advanced arterial invasion so that are not able to continue radical surgery;\n2. ASA≥4；\n3. Patients who are not willing to be performed open and/or mi-RAMPS;\n4. Not pancreatic adenocarcinoma by posteroperative pathology.'}, 'identificationModule': {'nctId': 'NCT03770559', 'acronym': 'MIRROR', 'briefTitle': 'The Therapeutic Evaluation(Both Short-term and Long-term Outcome) of Minimal Invasive Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Minimal Invasive Versus Open Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'daimh-RAMPS'}, 'secondaryIdInfos': [{'id': 'No.2020-1-4011', 'type': 'OTHER_GRANT', 'domain': 'Beijing Capital Health Research and DEvelopment of Special'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open-RAMPS', 'description': 'Patients with pancreatic cancer treated by traditional open surgery', 'interventionNames': ['Procedure: Open RAMPS']}, {'type': 'EXPERIMENTAL', 'label': 'MI-RAMPS', 'description': 'Patients with pancreatic cancer treated by laparoscopic surgery', 'interventionNames': ['Procedure: Minimal Invasive RAMPS']}], 'interventions': [{'name': 'Minimal Invasive RAMPS', 'type': 'PROCEDURE', 'description': 'Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery', 'armGroupLabels': ['MI-RAMPS']}, {'name': 'Open RAMPS', 'type': 'PROCEDURE', 'description': 'Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery', 'armGroupLabels': ['Open-RAMPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Menghua Dai, M.D.', 'role': 'CONTACT', 'email': 'daimh@pumch.cn'}], 'facility': 'Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'HANYU ZHANG, M.D.', 'role': 'CONTACT', 'email': 'medzhy5813@126.com', 'phone': '01069152600'}, {'name': 'Yatong Li, M.D.', 'role': 'CONTACT', 'email': 'medzhy5813@126.com', 'phone': '861069155992'}], 'overallOfficials': [{'name': 'Menghua Dai, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'PUMCH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD is not avaiable, but statistical data is avaiable'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Municipal Health Commission', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dai Menghua', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}