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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04783831
Other study ID # ARQUIMEDES
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date May 1, 2021

Study information

Verified date March 2021
Source Hospital Universitario Virgen de la Arrixaca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 1, 2021
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure). Exclusion Criteria: - Patients with soft pancreas or chronic pancreatitis.

Study Design


Intervention

Device:
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.

Locations

Country Name City State
Spain David Ferreras Murcia

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary POPF Evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day). 1 week
Secondary Position and degradation of biodegradable stents Evaluation of the position and degradation time of the biodegradable stents 3 months
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