Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-26 @ 7:47 PM
Study NCT ID:
NCT02350166
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2015-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Effects of LASI Surgery Versus Conventional Laparotomy for Colorectal Liver Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-15', 'studyFirstSubmitDate': '2015-01-19', 'studyFirstSubmitQcDate': '2015-01-24', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day complications', 'timeFrame': 'Postoperative 30 days', 'description': 'Postoperative 30-day complications including anastomotic leakage, infection, and bile leakage'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Postoperative 7 days', 'description': 'Postoperative pain assessment'}, {'measure': 'Hospital time', 'timeFrame': 'an expected average of 7 days', 'description': 'Postoperative stay in hospital'}, {'measure': 'C-reactive protein', 'timeFrame': 'Postoperative 5 days', 'description': 'serum C-reactive protein level after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal cancer', 'hepatectomy', 'laparoscopic surgery', 'laparotomy', 'complications'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '21296855', 'type': 'BACKGROUND', 'citation': 'Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.'}, {'pmid': '21685461', 'type': 'BACKGROUND', 'citation': 'Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin. 2011 Jul-Aug;61(4):212-36. doi: 10.3322/caac.20121. Epub 2011 Jun 17.'}, {'pmid': '16904315', 'type': 'BACKGROUND', 'citation': 'Van Cutsem E, Nordlinger B, Adam R, Kohne CH, Pozzo C, Poston G, Ychou M, Rougier P; European Colorectal Metastases Treatment Group. Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer. 2006 Sep;42(14):2212-21. doi: 10.1016/j.ejca.2006.04.012. Epub 2006 Aug 10.'}, {'pmid': '10615075', 'type': 'BACKGROUND', 'citation': 'Kemeny N, Huang Y, Cohen AM, Shi W, Conti JA, Brennan MF, Bertino JR, Turnbull AD, Sullivan D, Stockman J, Blumgart LH, Fong Y. Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. N Engl J Med. 1999 Dec 30;341(27):2039-48. doi: 10.1056/NEJM199912303412702.'}, {'pmid': '17925551', 'type': 'BACKGROUND', 'citation': "Tomlinson JS, Jarnagin WR, DeMatteo RP, Fong Y, Kornprat P, Gonen M, Kemeny N, Brennan MF, Blumgart LH, D'Angelica M. Actual 10-year survival after resection of colorectal liver metastases defines cure. J Clin Oncol. 2007 Oct 10;25(29):4575-80. doi: 10.1200/JCO.2007.11.0833."}, {'pmid': '22971038', 'type': 'BACKGROUND', 'citation': 'Li ZQ, Liu K, Duan JC, Li Z, Su CQ, Yang JH. Meta-analysis of simultaneous versus staged resection for synchronous colorectal liver metastases. Hepatol Res. 2013 Jan;43(1):72-83. doi: 10.1111/j.1872-034X.2012.01050.x. Epub 2012 Sep 13.'}, {'pmid': '24489916', 'type': 'BACKGROUND', 'citation': 'Wei M, He Y, Wang J, Chen N, Zhou Z, Wang Z. Laparoscopic versus open hepatectomy with or without synchronous colectomy for colorectal liver metastasis: a meta-analysis. PLoS One. 2014 Jan 29;9(1):e87461. doi: 10.1371/journal.pone.0087461. eCollection 2014.'}, {'pmid': '23183871', 'type': 'BACKGROUND', 'citation': 'Arezzo A, Passera R, Scozzari G, Verra M, Morino M. Laparoscopy for rectal cancer reduces short-term mortality and morbidity: results of a systematic review and meta-analysis. Surg Endosc. 2013 May;27(5):1485-502. doi: 10.1007/s00464-012-2649-x. Epub 2012 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'Surgical resection is still recommended as the optional treatment for colorectal liver metastasis (CLM) patients. There are two main concerns for resectable colorectal liver metastasis which remain controversial: surgical time and surgical type. As for the former, synchronous resection of primary colorectal tumor and liver metastasis, with the reason of fare overall survival rate and absence of a second surgery, has gained wide population from gastrointestinal surgeons who believe it will bring benefits to CLM patients. With regard to surgical type, Open liver resection is the optimum choice for CLM patients no matter what the metastasis profile is. And for management of primary tumor, laparoscopic procedure is mature in surgical skill and has been evidenced equivalent overall survival rate compared with open resection. So, primary colorectal tumor resection could be either open or laparoscopic procedure. Therefore, the investigators team conducted the controlled trial to compare two surgical procedures in treatment of resectable colorectal liver metastasis. Patients will be randomly assigned into conventional laparotomy group for simultaneously resection of both primary colorectal tumor and liver metastasis, or laparoscopic-assisted small-incision group for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis. The aim of this trial is to observing short-term operative effects after surgeries.', 'detailedDescription': 'Nowadays, colorectal liver metastasis (CLM) is gaining wide population from multi-disciplinary doctors including gastroenterologists, oncologists, and hepatic doctors for its increasing incidence and poor prognosis. Nearly, 15%-25% of colorectal cancer patients present with simultaneous liver metastasis at the time of diagnosis and 20%-35% patients are evaluated with primary tumor and liver metastasis resectable synchronously. Although the use of chemotherapy regimen has been certified favorable outcomes, surgical resection is still recommended as the optional treatment for CLM patients. However, there are two main concerns for resectable colorectal liver metastasis which remain controversial: surgical time and surgical type. As for the former, a latest evidence shows synchronous resection of primary colorectal tumor and liver metastasis, with the reason of fare overall survival rate and absence of a second surgery. Moreover, an increasing number of surgeons favor synchronous resection from their initial experience and they believe it will bring benefits to CLM patients.\n\nWith regard to surgical type, although laparoscopic liver resection has been proven feasible, safe and efficient in management of liver metastasis, this procedure is limited in selected patients such as tumor size less than 10 centimeters or located in left liver. In addition, laparoscopic liver resection is technically difficult which is applied in most medical centers. So open liver resection may be the optimum choice for CLM patients no matter what the metastasis profile is. In the management of primary tumor, laparoscopic procedure is mature in surgical skill and has been evidenced equivalent overall survival rate compared with open resection. A research conducted by Arezzo also confirms lower 30-day morbidity of laparoscopic colorectal cancer resection. Unlike liver metastasis resection, primary colorectal tumor resection could be either open or laparoscopic procedure.\n\nTherefore, the investigators team conducted the controlled trial to compare two surgical procedures in treatment of resectable colorectal liver metastasis. Patients will be randomly assigned into conventional laparotomy group for simultaneously resection of both primary colorectal tumor and liver metastasis, or laparoscopic-assisted small-incision group for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis. The aim of this trial is to observing short-term operative effects after surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically confirmed resectable upper rectal cancer, sigmoid cancer, and left colon cancer\n2. MRI/CT confirmed resectable liver metastasis after muti-disciplinary team assessment\n3. No evidence of other metastasis\n4. Organs function well to tolerance simultaneous surgery, especially liver function\n5. No special treatment before surgery\n6. Informed consent was written\n\nExclusion Criteria:\n\n1. Right colon cancer and transverse colon cancer\n2. Pregnant or lactating women\n3. A history of malignant tumor within 5 years\n4. There was contraindication for operation\n5. Discovery of metastasis in other organs in the operation\n6. With mental disorder'}, 'identificationModule': {'nctId': 'NCT02350166', 'briefTitle': 'Short-term Effects of LASI Surgery Versus Conventional Laparotomy for Colorectal Liver Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Short-term Effects of Laparoscopic-assisted Small-incision Surgery Versus Conventional Laparotomy in Treatment of Resectable Colorectal Liver Metastasis', 'orgStudyIdInfo': {'id': 'sLRC-201312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic group', 'description': 'Laparoscopic group, laparoscopic surgery or laparoscopic-assisted small-incision for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis', 'interventionNames': ['Procedure: laparoscopic surgery']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional group', 'description': 'Conventional group, conventional laparotomy for simultaneously resection of both primary colorectal tumor and liver metastasis'}], 'interventions': [{'name': 'laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'laparoscopic-assisted small-incision surgery', 'armGroupLabels': ['Laparoscopic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ziqiang Wang, PhD,MD', 'role': 'CONTACT', 'email': 'wzqtrial@gmail.com', 'phone': '+8618980602028'}], 'facility': 'West China hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ziqiang Wang, MD/PhD', 'role': 'CONTACT', 'email': 'wzqtrial@gmail.com', 'phone': '+86-18980602028'}, {'name': 'Mingtian Wei, MD', 'role': 'CONTACT', 'email': 'm.weihx@gmail.com', 'phone': '+86-13198596090'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Mingtian Wei, MD', 'role': 'CONTACT', 'email': 'm.weihx@gmail.com', 'phone': '+8613198596090'}, {'name': 'Xiangbing Deng, MD', 'role': 'CONTACT', 'email': 'xiangbingdeng@gmail.com', 'phone': '+8613730677124'}], 'overallOfficials': [{'name': 'Ziqiang Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of the West China Hospital, Sichuan University', 'investigatorFullName': 'Ziqiang Wang,MD', 'investigatorAffiliation': 'West China Hospital'}}}}