Clinical Trials Logo
  1. Home
  2. Pancreatic Fistula
  3. NCT05687825
  4. Details
NCT05687825 Clinical Trial

Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

Pancreatic Fistula Clinical Trial

Official title:
Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05687825
Other study ID # SVU/MED/SUR011/4/23/4/612
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date July 30, 2022

Study information
Verified date July 2023
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Description:

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Recruitment information / eligibility
Status Completed
Enrollment 107
Est. completion date July 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas. 2. American Society of Anesthesiologists (ASA) scores I & II. 3. Patients aged > 20 years. 4. Agreement to complete the study. Exclusion Criteria: 1. Patients with benign disease, trauma, and receive neoadjuvant therapy. 2. double primary cancers.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• pancreaticoduodenectomy procedure
Pancreaticoduodenectomy operation

Locations
Country Name City State
Egypt Qena faculty of Medicine, South Valley University Cairo

Sponsors (1)
Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinically relevant post operative pancreatic fistula A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day 10 days
See also
  Status Clinical Trial Phase
Completed NCT01696903 - Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy N/A
Completed NCT01301222 - Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas Phase 4
Recruiting NCT05155878 - Prognostic Factors in Periampullary Tumors and Cysts
Terminated NCT03757455 - ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy N/A
Recruiting NCT05212350 - Total pancrEaTectomy vs High-Risk Pancreatic anastomosiS N/A
Completed NCT04609137 - Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist) N/A
Recruiting NCT04798560 - Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy
Completed NCT03627559 - Early Detection of Anastomotic Leakage by Microdialysis Catheters
Completed NCT01550406 - Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy Phase 4
Recruiting NCT04783831 - Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy
Not yet recruiting NCT05387538 - One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy . N/A
Active, not recruiting NCT02775227 - HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications Phase 4
Completed NCT02790333 - Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula N/A
Not yet recruiting NCT05657366 - Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy N/A
Completed NCT03419676 - Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy Phase 3
Recruiting NCT05297136 - Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy N/A
Completed NCT00931554 - Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections N/A
Completed NCT00679952 - Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy Phase 3
Recruiting NCT04380506 - Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management N/A
Recruiting NCT06283160 - Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy