Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-01 @ 5:53 PM
Study NCT ID:
NCT03238820
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2017-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single group, open study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-07-31', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': '1 month', 'description': 'Intraoperative and postoperative complications'}], 'secondaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': '1 day', 'description': 'Blood loss'}, {'measure': 'Operative time', 'timeFrame': '1 day', 'description': 'Operative time'}, {'measure': 'Resection style', 'timeFrame': '1 day', 'description': 'The wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.'}, {'measure': 'Postoperative length of stay', 'timeFrame': '1 month', 'description': 'Postoperative length of stay'}, {'measure': 'Inflammation level', 'timeFrame': '1 month', 'description': 'Inflammation level'}, {'measure': 'Nutritional status', 'timeFrame': '6 months', 'description': 'Nutritional status'}, {'measure': 'Body composition', 'timeFrame': '6 months', 'description': 'Body composition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal stromal tumors', 'Robot', 'manual suture'], 'conditions': ['Gastrointestinal Stromal Tumor of Stomach']}, 'descriptionModule': {'briefSummary': 'Patients with gastric gastrointestinal stromal tumors will receive robotic resection.', 'detailedDescription': 'Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract. Approximately 60% of tumors develop in the stomach.Before, patients with gastric gastrointestinal stromal tumors would receive open or laparoscopic surgery. However, gastrointestinal stromal tumors located at special sites, such as cardia, were hardly treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then, we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable.\n2. Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex.\n3. American Society of Anesthesiologists (ASA) physical status I-III.\n4. Participants can follow the visit plan.\n\nExclusion Criteria:\n\n1. Patients certified by a doctor that doesn't fit to participate in this study.\n2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function \\> II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).\n3. Patients with gastrointestinal stromal tumor with distant metastasis.\n4. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance \\< 25 ml/min).\n5. Patients with gastrointestinal operations and complicated abdominal operations.\n6. Patients with severe malnutrition (albumin≤30g/L, weight loss in half a year\\>10%, Subjective Global Assessment (SGA) classification C, body mass index \\<18, Hb\\<70g/L).\n7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).\n8. Patients participated other subjects 3 months before this subject.\n9. Sponsors or researchers directly involved in the testing or their family members."}, 'identificationModule': {'nctId': 'NCT03238820', 'briefTitle': 'Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study', 'orgStudyIdInfo': {'id': 'BE2015687GIST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The robot group', 'description': 'Patients undergo robotic gastric gastrointestinal stromal tumors resection.', 'interventionNames': ['Procedure: Robotic gastric gastrointestinal stromal tumors resection']}], 'interventions': [{'name': 'Robotic gastric gastrointestinal stromal tumors resection', 'type': 'PROCEDURE', 'description': 'Robotic gastric gastrointestinal stromal tumors resection', 'armGroupLabels': ['The robot group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jinling Hospital, Medical School of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Zhi-Wei JIANG, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinling Hospital, Medical School of Nanjing University'}, {'name': 'Jian ZHAO, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jinling Hospital, Medical School of Nanjing University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The results and IPD might be considered to share in published articles.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JIANG Zhi-Wei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice director of Research Institute of General Surgery', 'investigatorFullName': 'JIANG Zhi-Wei', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}