Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT02936193
Status:
UNKNOWN
Last Update Posted:
2019-11-05
First Post:
2016-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005763', 'term': 'Gastroenterostomy'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-03', 'studyFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': '3 years', 'description': 'It is the time that passes from the first date after treatment and the date on which gastric cancer progresses, as demonstrated by laboratory testing, radiologic testing, or clinically.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days'}, {'measure': 'Postoperative mortality', 'timeFrame': '30 days'}, {'measure': '3 years overall survival', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC.', 'detailedDescription': 'During the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. The right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. In addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. The celiac branch of the posterior vagal trunk is sometimes preserved. All regional nodes except the suprapyloric nodes (No. 5) should be dissected as in the standard D2 procedure. However, there are technical challenges associated with completing all of these procedures.The five-year survival rate after PPG with modified D2 lymph node dissection ranges from 95% to 98%. This rate is comparable to the five-year survival rate after gastric resection for EGC, which ranges from 90% to 98%. In terms of oncologic safety, PPG seems reasonably safe for EGC when the accuracy of preoperative diagnosis can be assured'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18 and younger than 75 years\n* Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy\n* cT1-2N0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition\n* Expected curative resection via distal subtotal gastrectomy with D2 lymphadenectomy\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Severe mental disorder\n* Previous upper abdominal surgery (except laparoscopic cholecystectomy)\n* Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection\n* Other malignant disease within the past 5 years\n* Previous neoadjuvant chemotherapy or radiotherapy\n* Unstable angina, myocardial infarction, or cerebrovascular accident within the past 6 months\n* Continuous systematic administration of corticosteroids within 1 month before the study\n* Requirement of simultaneous surgery for other diseases\n* Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer'}, 'identificationModule': {'nctId': 'NCT02936193', 'acronym': 'LAPPG', 'briefTitle': 'Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'LAPPG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pylorus preservation', 'description': 'Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation', 'interventionNames': ['Procedure: Pylorus preservation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Distal gastrectomy', 'description': 'Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy', 'interventionNames': ['Procedure: Distal gastrectomy']}], 'interventions': [{'name': 'Pylorus preservation', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopic-assisted pylorus preserving gastrectomy'], 'description': 'Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation', 'armGroupLabels': ['Pylorus preservation']}, {'name': 'Distal gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopic-assisted distal gastrectomy'], 'description': 'Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy', 'armGroupLabels': ['Distal gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Lu', 'role': 'CONTACT', 'email': 'rjluqi@hotmail.com', 'phone': '0086-021-68383364'}], 'facility': 'Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Cao, PhD', 'role': 'CONTACT', 'email': 'caohuishcn@hotmail.com', 'phone': '0086-021-686383751'}], 'facility': 'Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lin Tu, MD', 'role': 'CONTACT', 'email': 'tl19870228@hotmail.com', 'phone': '008618616547270'}, {'name': 'Gang Zhao, PhD', 'role': 'CONTACT', 'email': 'zhaogang74313@aliyun.com', 'phone': '0086-021-68383731'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}