Reoperation After Pancreaticoduodenectomy

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04387903
• Other study ID #: R.20.04.819
• Status: Active, not recruiting
• Start date: January 1, 2000
• Est. completion date: August 1, 2020

Study information

• Verified date: May 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2020
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Periampullary Carcinoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survival	The duration between surgical intervention to patient death	2-20 years after surgery
Primary	Tumor recurrence	Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.	2-20 years
Secondary	Hospital stay after reoperation	duration between reoperation surgery to discharge from hospital	10-90 days after reoperation
Secondary	Morbidity after reoperation	complications after reoperation including intr- or extra-luminal hemorrhage, pancreatic or gastric fistula, biliary leakage, thromboembolic diseases, and wound infection	10-90 days after reoperation
Secondary	Risk factors for surgical reoperation	Factors that increase the probability that the patient undergoing pancreaticoduodenectomy would be at higher risk for reoperation	Before surgical intervention