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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04387903
Other study ID # R.20.04.819
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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