Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02511951
Status:
UNKNOWN
Last Update Posted:
2015-08-18
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010185', 'term': 'Pancreatic Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010193', 'term': 'Pancreaticojejunostomy'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-16', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-07-29', 'lastUpdatePostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pancreatic fistula(POPF) rate', 'timeFrame': '30 days', 'description': 'drainage of any measurable volume of fluid with an amylase content \\>3 times the upper normal serum value on or after postoperative day 3.'}], 'secondaryOutcomes': [{'measure': 'Duration of postoperative hospital stay', 'timeFrame': '30 days', 'description': 'Time from day of operation to day of discharge'}, {'measure': 'anastomosis time', 'timeFrame': '1 hour', 'description': 'anastomosis time was calculated from begining to the end of pancreaticojejunostomy'}, {'measure': 'reoperation rate', 'timeFrame': '30 days', 'description': 'The secondary endpoint will be the reoperation rate'}, {'measure': 'Morbidity', 'timeFrame': '30 days', 'description': 'the severity of complications was graded according to the Clavien-Dindo classification'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'operative mortality was defined as any death resulting from a complication during surgery'}, {'measure': 'Biliary leakage', 'timeFrame': '30', 'description': 'biliary leakage was documented in line with the International Study Group of Liver Surgery(ISGLS) definitions and grading systems'}, {'measure': 'Blood transfusion', 'timeFrame': '2 days', 'description': 'Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['postoperative pancreatic fistula', 'postoperative hospital stay time', 'anastomosis time', 'reoperation rate', 'morbidity', 'pancreaticojejunostomy', 'pancreaticoduodenectomy'], 'conditions': ['Pancreatic Fistula']}, 'referencesModule': {'references': [{'pmid': '25840535', 'type': 'RESULT', 'citation': 'Zhang L, Li Z, Wu X, Li Y, Zeng Z. Sealing pancreaticojejunostomy in combination with duct parenchyma to mucosa seromuscular one-layer anastomosis: a novel technique to prevent pancreatic fistula after pancreaticoduodenectomy. J Am Coll Surg. 2015 May;220(5):e71-7. doi: 10.1016/j.jamcollsurg.2014.12.047. Epub 2015 Jan 15. No abstract available.'}, {'pmid': '26037262', 'type': 'RESULT', 'citation': 'Wei J, Liu X, Wu J, Xu W, Zhou J, Lu Z, Chen J, Guo F, Gao W, Li Q, Jiang K, Dai C, Miao Y. Modified One-layer Duct-to-mucosa Pancreaticojejunostomy Reduces Pancreatic Fistula After Pancreaticoduodenectomy. Int Surg. 2015 Jun 3. doi: 10.9738/INTSURG-D-15-00094.1. Online ahead of print.'}, {'pmid': '25682724', 'type': 'RESULT', 'citation': 'El Nakeeb A, El Hemaly M, Askr W, Abd Ellatif M, Hamed H, Elghawalby A, Attia M, Abdallah T, Abd ElWahab M. Comparative study between duct to mucosa and invagination pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized study. Int J Surg. 2015 Apr;16(Pt A):1-6. doi: 10.1016/j.ijsu.2015.02.002. Epub 2015 Feb 13.'}, {'pmid': '27530630', 'type': 'DERIVED', 'citation': 'Pan SB, Geng W, Zhou DC, Chen JM, Zhao HC, Liu FB, Xie SX, Hou H, Zhao YJ, Xie K, Wang GB, Geng XP. One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial. Trials. 2016 Aug 17;17(1):407. doi: 10.1186/s13063-016-1517-8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "One-layer duct-to-mucosa pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.', 'detailedDescription': 'Pancreaticoduodenectomy is a standard surgical approach for resectable pancreatic tumors and periampullary tumors. It is considered a safe procedure resulting from the continuous improvement in surgical techniques over the years. Although postoperative mortality has obviously decreased, pancreatic fistula is still a major challenge in pancreatic surgery and remains the major cause of postoperative morbidity and mortality after pancreaticoduodenectomy(PD), ranging from 3% to 30%.\n\nMany risks factors have been shown to cause pancreatic fistula(PF) after the operation, including advanced age, prolonged operation time, intraoperative hemorrhage, BMI, soft pancreas, size of the main pancreatic duct and texture of the remnant pancreas. Among them, soft pancreatic texture without a dilated main pancreatic duct is regarded as the most important risk factor in predicting pancreatic fistula.\n\nThe serious consequences of pancreatic fistula result from the pancreatic juice becoming activated by the bile and intestinal fluid, which will eventually corrupt the PJ anastomosis and the surrounding normal tissues. The corrosion of the vasculature will lead to lethal hemorrhage, which is the main cause of mortality after pancreaticoduodenectomy. Furthermore, pancreatin, together with the bacteria in the alimentary tract, will lead to intra-abdominal infection and abscess. To reduce the pancreatic fistula rate, several techniques have been described as alternatives to the conventional PJ anastomosis. Duct-to-mucosa sutures, binding pancreaticojejunostomy and end-to-side invaginated fashion are widely used in the current clinical setting. Some non-randomized studies showed that the one-layer duct-to-mucosa method was a relatively safe approach. However, the prospective clinical study found that in comparison with the conventional two-layer duct-to-mucosa did obviously decrease the incidence of pancreatic fistula as well as other operative complications. The postoperative pancreatic fistula (POPF), which determines postoperative mortality, length of hospital stay， is dependent of its definition, and is reported in up to 16% of patients. The purpose of this study is to determine whether the new anastomosis called " one-layer duct-to-mucosa " pancreaticojejunostomy can reduce the POPF rate and downgrade compared with the common accepted duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following International Study Group on Pancreatic Fistula (ISGPF) criteria for pancreatic fistula (PF). The primary endpoint is the POPF rate, and others include overall postoperative complication rate and their severity reoperation rate and hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and female, aged 18 to 80;\n* Patients scheduled to undergo pancreaticoduodenectomy;\n* Provided written informed consent;\n\nExclusion criteria:\n\n* Patients with severe cardiopulmonary disorder that might prolong the postoperative hospital stay;\n* Patients who had a previous pancreatic operation;\n* Patients with an immunodeficiency;\n* Patients who underwent an emergency operation;\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT02511951', 'briefTitle': 'One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Anhui Medical University'}, 'officialTitle': 'A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy', 'orgStudyIdInfo': {'id': 'ahykdxdefsyy11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'one-layer duct-to-mucosa anastomosis', 'description': 'one-layer duct-to-mucosa anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.', 'interventionNames': ['Procedure: pancreaticojejunostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'two-layer duct-to-mucosa anastomosis', 'description': 'two-layer duct-to-mucosa anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.', 'interventionNames': ['Procedure: pancreaticojejunostomy']}], 'interventions': [{'name': 'pancreaticojejunostomy', 'type': 'PROCEDURE', 'description': 'To create the posterior suturing layers, the needle is inserted from the posterior interior side of the pancreatic duct, passing through the dorsal region of the parenchyma of the pancreatic stump to the posterior surface of the pancreas approximately 0.5 cm distal to the cut edge. The other side of the needle starts from the inside of the jejunum lumen to the subserosa and then passes through the seromuscular layer to the posterior surface of the bowel.The anterior suturing layer is performed in the same manner.\n\nTwo layer anatomosis with "Duct-to-Mucosa" pancreaticojejunostomy is performed by suturing the pancreatic parenchyma to the jejunal seromuscular layer and no stenting tube was used.', 'armGroupLabels': ['one-layer duct-to-mucosa anastomosis', 'two-layer duct-to-mucosa anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Geng Xiaoping', 'role': 'CONTACT', 'email': 'xp_geng@163.net', 'phone': '86+13956010132'}, {'name': 'shubo pan', 'role': 'CONTACT', 'email': 'aydpanshubo@126.com', 'phone': '86+15856943673'}], 'facility': 'the Second Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'xiaoping geng, professor', 'role': 'CONTACT', 'email': 'xp_geng@163.net', 'phone': '86+13956010132'}, {'name': 'shubo pan, master', 'role': 'CONTACT', 'email': 'aydpanshubo@126.com', 'phone': '86+15856943673'}], 'overallOfficials': [{'name': 'xiaoping geng, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the vice President of the second affiliated hospitalof Anhui medical university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Anhui Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice-president', 'investigatorFullName': 'xpgeng', 'investigatorAffiliation': 'The Second Hospital of Anhui Medical University'}}}}