Pancreatic Fistula Clinical Trial
Official title:
The Use of Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective, Randomized Clinical Trial
The primary objective of this study is to evaluate the effectives of enteral nutrition in the treatment of pancreatic fistulas. The ratio of pancreatic fistula closure after 30 days is selected as the primary outcome measure with the null hypothesis assuming that enteral nutrition provides better results than parenteral nutrition as far as the closure ratio, time to closure and treatment-related complications are concerned.
The research into field of the role of enteral nutrition in the treatment of pancreatic
fistulas is fully justified by the lower cost and complications' rate of EN compared to PN
observed in clinical trials comparing enteral and parnetral route of feeding in pre- and
postoperative period. Such authors as Braga, Torosian, Lewis or Sand et al. proved that use
of enteral nutrition led to smaller amount of complication (especially infectious) and
improved the outcome of surgery. The only method to verify the role of enteral nutrition is
the prospective, randomized clinical trial.
STUDY OBJECTIVES 2.1 Primary Objective The primary objective of this study is to evaluate
the effectives of enteral nutrition in the treatment of pancreatic fistulas. The ratio of
pancreatic fistula closure after 30 days is selected as the primary outcome measure with the
null hypothesis assuming that enteral nutrition provides better results than parenteral
nutrition as far as the closure ratio, time to closure and treatment-related complications
are concerned.
2.2 Secondary Objectives
The secondary objectives are to:
- determine time to fistula closure (defined as time between initiation of treatment and
confirmed fistula closure),
- determine rates of fistula and treatment-related complications,
- assess changes in quality of life (QoL),
- determine economic costs of therapy. (for such terms as: fistula closure, time to
closure see definition on page 3) For QoL assessment the EORTC QLQ - PAN26 score in
Polish version (translation was approved by EORTC) will be used.
Benefits of the study:
1. the implementation of safer and less expensive conservative procedure. Basis: Costs of
enteral nutrition are significantly lower than PN and EN is significantly safer than PN
especially as far as infectious complications are concerned.
2. the enhancement of indications for enteral nutrition.
The confirmation of the null hypothesis allows recommending enteral nutrition as a method of
choice for pancreatic fistula treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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
|