Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-02-24 @ 7:03 PM
Study NCT ID:
NCT02954302
Status:
UNKNOWN
Last Update Posted:
2016-11-03
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D004379', 'term': 'Duodenal Neoplasms'}, {'id': 'D018589', 'term': 'Gastroparesis'}], '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'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-11-01', 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'nonsurgical complications,rate', 'timeFrame': '60 days after operation'}], 'primaryOutcomes': [{'measure': 'Delayed gastric emptying,rate', 'timeFrame': '60 days after operation', 'description': "The severity of DGE was classified into 3 grades (A, B, or C) according to the ISGPS's clinical criteria, based on the patient's clinical course and postoperative management, such as the need for NGT in the postoperative period or the inability to tolerate solid oral intake.\n\nGrade A was defined as needing the NGT for more than 7 days or reinsertion of the NGT after postoperative day 3, or as being unable to tolerate a solid diet by postoperative day 7.\n\nGrade B was defined as needing for NGT for 8 to 14 days after surgery or reinsertion of the NGT after day 7, or as being unable to tolerate a solid diet by postoperative day 14.\n\nGrade C was defined as needing the NGT for more than 14 days or reinsertion of the NGT after day 14, or as being unable to tolerate a solid diet by day 21."}], 'secondaryOutcomes': [{'measure': 'Morbidity,rate', 'timeFrame': '60 days after operation'}, {'measure': 'Mortality,rate', 'timeFrame': '60 days after operation'}, {'measure': 'Length of hospital stay,days', 'timeFrame': '60 days after operation'}, {'measure': 'Pancreatic fistula,rate', 'timeFrame': '60 days after operation'}, {'measure': 'Hemorrhage,rate', 'timeFrame': '60 days after operation'}, {'measure': 'Bile leakage,rate', 'timeFrame': '60 days after operation'}, {'measure': 'Intra-abdominal abscess,rate', 'timeFrame': '60 days after operation'}, {'measure': 'wound infection,rate', 'timeFrame': '60 days after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Delayed gastric emptying', 'pancreaticoduodenectomy'], 'conditions': ['Pancreatic Cancer', 'Bile Duct Cancer', 'Duodenal Cancer']}, 'referencesModule': {'references': [{'pmid': '26850262', 'type': 'RESULT', 'citation': 'Barakat O, Cagigas MN, Bozorgui S, Ozaki CF, Wood RP. Proximal Roux-en-y Gastrojejunal Anastomosis with Pyloric Ring Resection Improves Gastric Emptying After Pancreaticoduodenectomy. J Gastrointest Surg. 2016 May;20(5):914-23. doi: 10.1007/s11605-016-3091-5. Epub 2016 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether the incidence of delayed gastric emptying (DGE) can be reduced by proximal Roux-en-y gastrojejunal anastomosis in comparison with the standard gastrojejunal anastomosis in pylorus-resecting pancreaticoduodenectomy (PrPD).', 'detailedDescription': 'Delayed gastric emptying (DGE) is a common complication after pancreaticoduodenectomy (PD), occurring in 20% to 70% of the patients. DGE is usually not a life-threatening complication, but it contributes significantly to increased length of hospital stay, health care costs, and patient discomfort. In a recent study by Sakamoto et al, proximal Roux-en-y gastrojejunal anastomosis is associated with a reduced incidence of DGE after pylorus-resecting pancreaticoduodenectomy (PrPD); however, these results may have been biased because of the retrospective nature. Therefore, the investigators conducted the present randomized controlled trial (RCT) to evaluate the impact of the proximal Roux-en-y gastrojejunal anastomosis on reducing DGE following PrPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were scheduled to undergo PD and provided written informed consent.\n* In the opinion of the surgeon, the subject has no medical contraindications to PD.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Patients who underwent other surgical procedures than PD, such as total pancreatectomy (TP) or a palliative biliary and gastroenteric anastomosis.\n* Drug abusers or alcoholics.\n* Patient who have previous transabdominal surgery.\n* The patient who were scheduled to undergo laparoscopic PD.\n* The patient who does not want to participate the clinical trials.'}, 'identificationModule': {'nctId': 'NCT02954302', 'briefTitle': 'Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xiamen University'}, 'officialTitle': 'Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FAHXMU-2016-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PrPD with RGA', 'description': 'Patients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis.', 'interventionNames': ['Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis']}, {'type': 'EXPERIMENTAL', 'label': 'conventional PrPD', 'description': 'Patients who will undergo conventional PrPD.', 'interventionNames': ['Procedure: conventional PrPD']}], 'interventions': [{'name': 'PrPD with proximal Roux-en-y gastrojejunal anastomosis', 'type': 'PROCEDURE', 'description': 'the distal antrum was divided about 1 to 2 cm proximal to the pylorus ring, preserving more than 95% of the stomach. The proximal jejunum was divided approximately 2 to 4 cm distal to the duodeno-jejunal junction. After completion of the resection, the proximal end of the first loop of jejunum was then brought through the transverse mesocolon, and the gastrojejunal anastomosis (GJA) was performed in two layers by using 3-0 PDS sutures and 4-0 silk sutures in an end-to-side fashion. The jejunum was then divided 35 to 40 cm distal to the GJA, and the distal limb was brought separately through the transverse mesocolon to be placed in the duodenal bed for reconstruction of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA).', 'armGroupLabels': ['PrPD with RGA']}, {'name': 'conventional PrPD', 'type': 'PROCEDURE', 'description': 'After completion of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA), a hand-sewn, isoperistaltic GJA was performed 25 to 30 cm distal to the HJA in two layers by using 3-0 polydioxanone (PDS) sutures and 4-0 silk sutures.', 'armGroupLabels': ['conventional PrPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361003', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Minqiang Lin, Dr', 'role': 'CONTACT', 'email': '80218353@qq.com', 'phone': '8605922139708', 'phoneExt': '8605922139908'}, {'name': 'Yanming Zhou, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaofeng Zhang, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Feng Yu, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lupeng Wu, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'AIling Song, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First affiliated Hospital of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Mingqiang Lin, Dr', 'role': 'CONTACT', 'email': '80218353@qq.com', 'phone': '8605922139708'}, {'name': 'Yanming Zhou, Dr', 'role': 'CONTACT', 'email': 'zhouymsxy@sina.cn', 'phone': '8605922139708'}], 'overallOfficials': [{'name': 'Yanming Zhou, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First affiliated Hospital of Xiamen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}