Clinical Trials Directory

Trials / Completed

CompletedNCT04724174

Pancreaticogastrostomy for High-Risk Pancreas

Double Purse-String Telescoped Pancreaticogastrostomy for High Risk Anastomosis: A 6-Year Single Center Case-Controlled Study

Status
Completed
Phase
Study type
Observational
Enrollment
198 (actual)
Sponsor
Institut Paoli-Calmettes · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ) techniques.

Detailed description

From 2013 to 2019, consecutive patients with high-risk anastomosis (i.e., updated alternative-Fistula Risk Score (ua-FRS) \>20%) underwent pancreatoduodenectomy with either the PJ or PG technique. Optimal mitigation strategy (external stenting and octreotide omission) was applied for all patients. The primary endpoint of the study was the incidence of clinically relevant POPF. Data were entered prospectively into an institutional clinical database (NCT02871336).

Conditions

Interventions

TypeNameDescription
PROCEDUREpancreaticogastrostomyPancreaticogastrostomy technique was performed according to the precise description of Addeo et al.
PROCEDUREpancreaticojejunostomyPancreaticojejunostomy technique was performed using the 5/0 polypropylene interrupted monofilament suture in a one-layered duct-to-mucosa end-to-side anastomosis (Cattell-Warren anastomosis).

Timeline

Start date
2013-06-01
Primary completion
2020-01-01
Completion
2020-01-31
First posted
2021-01-26
Last updated
2021-01-26

Source: ClinicalTrials.gov record NCT04724174. Inclusion in this directory is not an endorsement.