External Pancreatic Stent in Pancreaticojejunostomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pancreaticojejunostomy with external stent, Pancreaticojejunostomy without external stent.
- Who it may be relevant to
- Registry conditions: Pancreatic Fistula. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas
Overview
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
- Procedure Pancreaticojejunostomy with external stent
Inserting ureteric stent at the pancreaticojejunostomy site - Procedure Pancreaticojejunostomy without external stent
Only Pancreaticojejunostomy without inserting external stent
Primary outcome measures
- evidence of pancreatic fistula [Time frame: within the first 7 days after surgery( first day, third day and fifth day)]
Secondary outcome measures (1)
- evidence of intra abdominal collection [Time frame: first week, second week postoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Liver and GIT hospital , Minia University — Minya
Identifiers
NCT: NCT06743516 · 1282/10/2024