Pancreaticogastrostomy for High-Risk Pancreas

NCT04724174 | Completed

• 1 other identifier: GASTROPAN IPC-2020-029
• Study Type: observational
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anastomosis; Complications; Pancreatic Fistula

Keywords

High Risk Pancreatic Anastomosis; Clinically Relevant Pancreatic Fistula; Pancreaticogastrostomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pancreaticogastrostomy (PG) group

Patients underwent pancreatoduodenectomy with the PG technique

Procedure: pancreaticogastrostomy

Pancreaticojejunostomy (PJ) group

Patients underwent pancreatoduodenectomy with the PJ technique

Procedure: pancreaticojejunostomy

Interventions

pancreaticogastrostomy PROCEDURE

Pancreaticogastrostomy technique was performed according to the precise description of Addeo et al.

Pancreaticogastrostomy (PG) group

pancreaticojejunostomy PROCEDURE

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).

Pancreaticojejunostomy (PJ) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with pancreatic tumor who underwent pancreatoduodenectomy

You may qualify if:

• Pancreatoduodenectomy
• High updated alternative -Fistula Risk Score which was defined \> 20%, as the higher-risk category of the alternative-Fistula Risk Score

You may not qualify if:

• Explorative laparotomy
• Hard pancreatic parenchyma

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Pancreaticojejunostomy

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Olivier Turrini, PD

  Institut Paoli-Calmettes- (IPC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 26, 2021
• Study Start: June 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 31, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share