Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-05-01

Brief Summary

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Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications.

Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum.

The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).

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Detailed Description

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Conditions

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Pancreatic Fistula Pancreas Neoplasm Stent Disintegration Pancreatic Cancer Pancreatic Anastomotic Leak

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Biodegradable stent

Intervention Type DEVICE

Biodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis.

Non-biodegradable stent

Biodegradable stent

Intervention Type DEVICE

Biodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis.

Interventions

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Biodegradable stent

Biodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis.

Intervention Type DEVICE