Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-30 @ 2:28 PM
Study NCT ID:
NCT04387903
Status:
UNKNOWN
Last Update Posted:
2020-05-14
First Post:
2020-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reoperation After Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010185', 'term': 'Pancreatic Fistula'}], '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': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-10', 'studyFirstSubmitDate': '2020-05-10', 'studyFirstSubmitQcDate': '2020-05-10', 'lastUpdatePostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient survival', 'timeFrame': '2-20 years after surgery', 'description': 'The duration between surgical intervention to patient death'}, {'measure': 'Tumor recurrence', 'timeFrame': '2-20 years', 'description': 'Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.'}], 'secondaryOutcomes': [{'measure': 'Hospital stay after reoperation', 'timeFrame': '10-90 days after reoperation', 'description': 'duration between reoperation surgery to discharge from hospital'}, {'measure': 'Morbidity after reoperation', 'timeFrame': '10-90 days after reoperation', 'description': 'complications after reoperation including intr- or extra-luminal hemorrhage, pancreatic or gastric fistula, biliary leakage, thromboembolic diseases, and wound infection'}, {'measure': 'Risk factors for surgical reoperation', 'timeFrame': 'Before surgical intervention', 'description': 'Factors that increase the probability that the patient undergoing pancreaticoduodenectomy would be at higher risk for reoperation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreaticoduodenectomy, pancreatic fistula, pancreatic cancer, reoperation'], 'conditions': ['Periampullary Carcinoma', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to outline the incidence of early and late reoperation after PD, examine the risk factors for early surgical intervention and its impact on the surgical outcome, hospital stay, diseases recurrence and patient survival, address variable indications for late readmission and reoperation after PD and its impact on patient survival and disease recurrence.', 'detailedDescription': "This is a retrospective cohort study of all patients who underwent PD for periampullary tumors in Gastrointestinal Surgical Center (GISC), Mansoura University, Egypt in the period between 2000 and 2018.The exclusion criteria included any patients with locally advanced periampullary tumor, metastases, patients with advanced liver cirrhosis (Child B or C), malnutrition, or coagulopathy.\n\nPatient data were recorded in a prospectively maintained database. Preoperative variables included; age, sex, body mass index, patients' symptoms and signs, laboratory tests, tumor markers and preoperative biliary drainage. Intraoperative variables included; liver status, tumor size, pancreatic duct diameter, texture of the pancreas, operative time, blood loss, pancreatic reconstruction method and blood transfusion. Postoperative variables included postoperative complications, drain amylase, liver function, day to resume oral feeding, postoperative stay, re-exploration, hospital mortality, postoperative pathology, and surgical safety margins.\n\nData regarding reoperation included incidence, male to female ratio, hospital stay, interval to reoperation, number of explorations, indication of reoperation and surgical management, and postoperative outcome in terms of morbidity and hospital stay. Follow-up was carried out one week postoperatively, 3 months, 6 months and then after one year. The minimum duration of follow up was 2 years. Follow up was done by thorough history taking, clinical examination and abdominal CT in case of suspicious lesions on pelvi-abdominal ultrasound."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective cohort study of all patients who underwent PD for periampullary malignant lesions in the duration between January 2000 and May 2018.\n\nPreoperative assessment was performed by clinical examination and detailed laboratory investigations. Assessment of local extension of the tumor and metastatic work-up was performed by pelvi-abdominal ultrasound (US), triphasic abdominal computerized tomography (CT) with angiographic assessment of the surrounding vessels, bone survey, and chest X-ray. Preoperative endoscopic retrograde cholangiopancreatography (ERCP) for preoperative biliary drainage was performed in selected cases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients who underwent pancreaticoduodenectomy for periampullary malignant lesions in the duration between January 2000 and May 2018\n\nExclusion Criteria:\n\n* Pancreaticoduodenectomy performed for benign tumors, recurrent malignant tumors, chronic pancreatitis, or inflammatory strictures were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04387903', 'briefTitle': 'Reoperation After Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Surgical Intervention After Pancreaticoduodenectomy: Incidence, Indications, Risk Factors and Outcome', 'orgStudyIdInfo': {'id': 'R.20.04.819'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reoperation group', 'description': 'The group of patients who underwent pancreaticduodenectomy for management of periampullary tumors and required surgical reintervention afterwards for management of procedure-related complications as pancreatic fistula, bleeding, abdominal collection, biliary fistula, gastric fistula.', 'interventionNames': ['Procedure: Surgical re-interventionafter pancreaticoduodenectomy']}, {'label': 'No reoperation group', 'description': 'The group of patients who underwent pancreaticoduodenectomy for management of periampullary tumors and did not require surgical reintervention.', 'interventionNames': ['Procedure: Surgical re-interventionafter pancreaticoduodenectomy']}], 'interventions': [{'name': 'Surgical re-interventionafter pancreaticoduodenectomy', 'type': 'PROCEDURE', 'description': 'Mandatory surgical management of complications after pancreatico-duodenectomy through peritoneal lavage, draiange, repair of fistula, completion pancreatectomy, control of bleeding, bowel resection, and feeding jejunostomy.', 'armGroupLabels': ['No reoperation group', 'Reoperation group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ayman El Nakeeb, md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Surgery, Gastrointestinal Surgical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be prepared as a research paper and the cohort results will be published in a scientific journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of general surgery', 'investigatorFullName': 'Hosam Hamed', 'investigatorAffiliation': 'Mansoura University'}}}}