Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT01433861
Status:
TERMINATED
Last Update Posted:
2017-01-09
First Post:
2011-09-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004942', 'term': 'Esophagitis, Peptic'}], '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'}, {'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'We planed to study later', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2011-09-10', 'studyFirstSubmitQcDate': '2011-09-13', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of reflux esophagitis', 'timeFrame': 'postoperative 3 month', 'description': 'Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score'}, {'measure': 'Rate of reflux esophagitis', 'timeFrame': 'postoperative 6 month', 'description': 'Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score'}, {'measure': 'Rate of reflux esophagitis', 'timeFrame': 'postoperative 12 month', 'description': 'Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric cancer', 'proximal gastrectomy', 'total gastrectomy', 'laparoscopy', 'reflux esophagitis', 'double tract reconstruction'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now.\n\nThe primary end point of this study is whether the rate of reflux esophagitis is different or not between LAPG and LATG. Through this study, we', 'detailedDescription': 'Prospective Randomized Clinical Trials between Laparoscopy-assisted Proximal Gastrectomy and Laparoscopy-assisted Total Gastrectomy.\n\nLAPG reconstruction: double tract reconstruction (3 anastomosis, intracorporeal Roux-en Y esophago-jejunostomy, extracorporeal gastro-jejunostomy 10cm below esophago-jejunostomy,extracorporeal jejuno-jejunostomy 20cm below gastro-jejunostomy)\n\nLATG reconstruction: intracorporeal Roux-en Y esophago-jejunostomy\n\nPrimary end point : incidence of reflux esophagitis after operation\n\nSample Size : LAPG 97 cases, LATG 97 cases (p1=0.018 p2=0.018, a=0.05, b=0.80) Non-inferiority test, non-inferior margin (delta) : 0.05. Sample size calculated by our MRCC(Medical Research Collaborating Center, http://mrcc.snubh.org)\n\nStudy duration : 48 months (enrollment 36months, follow-up 12months)\n\nReflux esophagitis evaluation methods\n\n1. Ambulatory 24hr-pH esophageal holter monitoring for acid reflux\n2. DISIDA scan for bile reflux\n3. Endoscopic evaluation (Grading according to LA classification)\n4. Visick score (subjective symptoms)\n5. EORTC sto 22 and GIQLI evaluation (Quality of Life)\n6. Nutritional Benefits (Body weight, Triceps Skin folds Thickness, Blood test)\n7. Upper gastrointestinal study\n8. Gastric emptying scan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20\\~80\n* Informed consent\n* No other malignancies\n* Proximal gastric cancer met by following conditions\n\n 1. Lesion located on proximal stomach (upper one third)\n 2. Lesion below 5cm in size\n 3. Lesion confined to proper muscle depth (cT2)\n 4. No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. (cN1)\n\nExclusion Criteria:\n\n* If patients is only suitable to total gastrectomy, he will be excluded.'}, 'identificationModule': {'nctId': 'NCT01433861', 'acronym': 'PRAPT', 'briefTitle': 'Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)', 'orgStudyIdInfo': {'id': 'SNUBHGS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LAPG', 'description': 'LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group', 'interventionNames': ['Procedure: Laparoscopy-assisted gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LATG', 'description': 'LATG : laparoscopy-assisted total gastrectomy group', 'interventionNames': ['Procedure: Laparoscopy-assisted gastrectomy']}], 'interventions': [{'name': 'Laparoscopy-assisted gastrectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy', 'armGroupLabels': ['LAPG', 'LATG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam', 'state': 'Gyenggi', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Hyung-Ho Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyung-Ho Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}