Clinical trial NCT04387903: Reoperation After Pancreaticoduodenectomy
Official title: Surgical Intervention After Pancreaticoduodenectomy: Incidence, Indications, Risk Factors and Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periampullary Carcinoma
Pancreatic Cancer
Keywords: Pancreaticoduodenectomy, pancreatic fistula, pancreatic cancer, reoperation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* all patients who underwent pancreaticoduodenectomy for periampullary malignant lesions in the duration between January 2000 and May 2018

Exclusion Criteria:

* Pancreaticoduodenectomy performed for benign tumors, recurrent malignant tumors, chronic pancreatitis, or inflammatory strictures were excluded from the study.

Primary outcomes:
measure: Patient survival
timeFrame: 2-20 years after surgery
measure: Tumor recurrence
timeFrame: 2-20 years
Secondary outcomes:
measure: Hospital stay after reoperation
timeFrame: 10-90 days after reoperation
measure: Morbidity after reoperation
timeFrame: 10-90 days after reoperation
measure: Risk factors for surgical reoperation
timeFrame: Before surgical intervention
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Surgery, Gastrointestinal Surgical Center
name: Ayman El Nakeeb, md
role: STUDY_DIRECTOR
References: