Pancreatic Fistula
Conditions
Brief summary
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.
Detailed description
The role of external pancreatic duct drainage in managing patients with a soft pancreas is particularly important, as these patients are at a heightened risk of developing postoperative complications. By providing an external route for pancreatic secretions, external pancreatic duct drainage may help to reduce the enzymatic activity at the anastomosis site and promote better healing. In addition to reducing the incidence of post operative pancreatic fistula, external pancreatic duct drainage may have other potential benefits, such as decreasing the length of hospital stay, reducing the need for additional interventions, and improving overall patient quality of life. However, these potential benefits must be weighed against the risks and drawbacks of external pancreatic duct drainage, including the potential for stent-related complications and the need for an additional procedure to remove the stent. •After being informed about the study and potential risks, all patients giving written consent. Patients who meet the eligibility requirements will be randomized in a 1:1 ratio to external pancreatic drainage group and no external pancreatic drainage group.
Interventions
PROCEDUREPancreaticojejunostomy with external stent
Inserting ureteric stent at the pancreaticojejunostomy site
PROCEDUREPancreaticojejunostomy without external stent
Only Pancreaticojejunostomy without inserting external stent
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Surgeons are not blinded due to the intervention's nature; data collectors, assessors, and analysts are blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications (e.g., pancreatic cancer, ampullary cancer, etc.). * Patients with a confirmed soft pancreas texture, as determined intraoperatively by the surgeon.
Exclusion criteria
* Patients with a hard or fibrotic pancreas, as determined intraoperatively by the surgeon. * Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severe cardiovascular disease, renal failure). * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evidence of pancreatic fistula | within the first 7 days after surgery( first day, third day and fifth day) | confirmed by serum and drain amylase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evidence of intra abdominal collection | first week, second week postoperative | confirmed by abdominal ultrasound and abdominal computed tomography |
Countries
Egypt
Contacts
CONTACTSaleh K Khairy, MD
CONTACTAnton F Basali, MBBCH
PRINCIPAL_INVESTIGATORSaleh K Saleh, MD
Minia University
Outcome results
None listed