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NCT Number: NCT04724174

Pancreaticogastrostomy for High-Risk Pancreas

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pancreaticogastrostomy

Procedure

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

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).

Primary outcomes

  1. Incidence of clinically relevant post operative pancreatic fistula

    Time frame: at hospital discharge assessed up to 30 days

    clinically relevant post operative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery (ISGPS) definition

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: GASTROPAN

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2021
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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