The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- evidence of pancreatic fistula
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Pancreaticojejunostomy with External stent
ureteric catheter (7Fr) insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.
Intervention: Pancreaticojejunostomy with external stent (Procedure)
Pancreaticojejunostomy without stent
Pancreaticojejunostomy without stent
Intervention: Pancreaticojejunostomy without external stent (Procedure)
Outcomes
Primary Outcomes
evidence of pancreatic fistula
Time Frame: within the first 7 days after surgery( first day, third day and fifth day)
confirmed by serum and drain amylase
Secondary Outcomes
- evidence of intra abdominal collection(first week, second week postoperative)
Investigators
Saleh Khairy Saleh MD
Lecturer
Minia University