Reoperation After Pancreaticoduodenectomy

Sponsor
Mansoura University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04387903
Collaborator
(none)
1,000
247

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical re-interventionafter pancreaticoduodenectomy

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Surgical Intervention After Pancreaticoduodenectomy: Incidence, Indications, Risk Factors and Outcome
Actual Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Reoperation group

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
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.

No reoperation group

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.

Outcome Measures

Primary Outcome Measures

  1. Patient survival [2-20 years after surgery]

    The duration between surgical intervention to patient death

  2. Tumor recurrence [2-20 years]

    Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.

Secondary Outcome Measures

  1. Hospital stay after reoperation [10-90 days after reoperation]

    duration between reoperation surgery to discharge from hospital

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Study Director: Ayman El Nakeeb, md, Professor of Surgery, Gastrointestinal Surgical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hosam Hamed, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier:
NCT04387903
Other Study ID Numbers:
  • R.20.04.819
First Posted:
May 14, 2020
Last Update Posted:
May 14, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hosam Hamed, Lecturer of general surgery, Mansoura University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2020