Clinical Trials Logo
  1. Home
  2. Pancreatic Fistula
  3. NCT04724174
  4. Details
NCT04724174 Clinical Trial

Pancreaticogastrostomy for High-Risk Pancreas

Pancreatic Fistula Clinical Trial

— GASTROPAN  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04724174
Other study ID # GASTROPAN IPC-2020-029
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2013
Est. completion date January 31, 2020

Study information
Verified date January 2021
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 198
Est. completion date January 31, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pancreatoduodenectomy - High updated alternative -Fistula Risk Score which was defined > 20%, as the higher-risk category of the alternative-Fistula Risk Score Exclusion Criteria: - Explorative laparotomy - Hard pancreatic parenchyma

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• pancreaticogastrostomy
Pancreaticogastrostomy technique was performed according to the precise description of Addeo et al.
• pancreaticojejunostomy
Pancreaticojejunostomy 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).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of clinically relevant post operative pancreatic fistula clinically relevant post operative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery (ISGPS) definition at hospital discharge assessed up to 30 days
See also
  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