Usefulness of Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy. Prospective Non-randomized Controlled Clinical Study Comparing Biodegradable vs Non-biodegradable Stents
Sponsor study identifier
observational
60
1 country
1
Study Start
November 1, 2018
Actual (reported)Primary Completion
December 1, 2018
Actual (reported)Study Completion
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2018
Actual (reported)December 1, 2018
Actual (reported)March 2, 2021
Actual (reported)March 5, 2021
Actual (reported)May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
POPF
Evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).
1 week
Position and degradation of biodegradable stents
3 months
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.
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Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
David Ferreras
Murcia, 30120, Spain
First Submitted
March 2, 2021
First Posted
March 5, 2021
Study Start
November 1, 2018
Actual (reported)Primary Completion
December 1, 2018
Actual (reported)Usefulness of 3D Digital Reconstruction in the Imaging Diagnosis of Pancreatic Tumors
Contact the study team to confirm eligibility.
Study Completion
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 9, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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