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Reoperation After Pancreaticoduodenectomy

Surgical Intervention After Pancreaticoduodenectomy: Incidence, Indications, Risk Factors and Outcome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04387903
Enrollment
1000
Registered
2020-05-14
Start date
2000-01-01
Completion date
2020-08-01
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer, Periampullary Carcinoma

Keywords

Pancreaticoduodenectomy, pancreatic fistula, pancreatic cancer, reoperation

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.

Interventions

PROCEDURESurgical 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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Patient survival2-20 years after surgeryThe duration between surgical intervention to patient death
Tumor recurrence2-20 yearsDuration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.

Secondary

MeasureTime frameDescription
Hospital stay after reoperation10-90 days after reoperationduration between reoperation surgery to discharge from hospital
Morbidity after reoperation10-90 days after reoperationcomplications after reoperation including intr- or extra-luminal hemorrhage, pancreatic or gastric fistula, biliary leakage, thromboembolic diseases, and wound infection
Risk factors for surgical reoperationBefore surgical interventionFactors that increase the probability that the patient undergoing pancreaticoduodenectomy would be at higher risk for reoperation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026