Reoperation After Pancreaticoduodenectomy

• Conditions: Periampullary Carcinoma; Pancreatic Cancer
• Interventions: Procedure: Surgical re-interventionafter pancreaticoduodenectomy

• Registration Number: NCT04387903
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2018-05-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-10
• Last Update Submitted: 2020-05-10
• Study First Posted: 2020-05-14
• Last Update Posted: 2020-05-14
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No reoperation group	Surgical re-interventionafter pancreaticoduodenectomy	The group of patients who underwent pancreaticoduodenectomy for management of periampullary tumors and did not require surgical reintervention.
Reoperation group	Surgical re-interventionafter pancreaticoduodenectomy	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.

Primary Outcome Measures

Name	Time	Method
Tumor recurrence	2-20 years	Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.
Patient survival	2-20 years after surgery	The duration between surgical intervention to patient death

Secondary Outcome Measures

Name	Time	Method
Hospital stay after reoperation	10-90 days after reoperation	duration between reoperation surgery to discharge from hospital
Morbidity after reoperation	10-90 days after reoperation	complications after reoperation including intr- or extra-luminal hemorrhage, pancreatic or gastric fistula, biliary leakage, thromboembolic diseases, and wound infection
Risk factors for surgical reoperation	Before surgical intervention	Factors that increase the probability that the patient undergoing pancreaticoduodenectomy would be at higher risk for reoperation