An observational study in Periampullary Carcinoma and Pancreatic Cancer, sponsored by Mansoura University. Status unknown. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-14.
Sponsored by Mansoura University · Observational
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.
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.
Patient 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.
Data 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.
3,311 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 636 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Mansoura University is the lead sponsor of 1,114 studies on the registry; 184 are open to participants now.
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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.
Preoperative 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
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Exclusion Criteria:
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.
Procedure: Surgical re-interventionafter pancreaticoduodenectomy
The group of patients who underwent pancreaticoduodenectomy for management of periampullary tumors and did not require surgical reintervention.
Procedure: Surgical re-interventionafter pancreaticoduodenectomy
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.
Patient survival
The duration between surgical intervention to patient death
Time frame: 2-20 years after surgery
Tumor recurrence
Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.
Time frame: 2-20 years
Hospital stay after reoperation
duration between reoperation surgery to discharge from hospital
Time frame: 10-90 days after reoperation
Morbidity after reoperation
complications after reoperation including intr- or extra-luminal hemorrhage, pancreatic or gastric fistula, biliary leakage, thromboembolic diseases, and wound infection
Time frame: 10-90 days after reoperation
Risk factors for surgical reoperation
Factors that increase the probability that the patient undergoing pancreaticoduodenectomy would be at higher risk for reoperation
Time frame: Before surgical intervention
No study locations are listed for this record.
Plan to share: No — The data will be prepared as a research paper and the cohort results will be published in a scientific journal.
No publications or documents are linked to this record.
Ran from Jan 2000 to primary completion in May 2018, 220 months.
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This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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