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Total pancrEaTectomy vs High-Risk Pancreatic anastomosiS

NCT05212350 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2022-01-28

No results posted yet for this study

Summary

Postoperative pancreatic fistula (POPF) is the main driver of surgical morbidity after pancreatoduodenectomy (PD). The aim of the present study is to compare total pancretectomy (TP) and primary pancreatic anastomosis (PA) in a cohort of extremely high-risk patients, with regards to postoperative outcomes and quality of life (QoL).

Conditions

  • Pancreatic Fistula

Interventions

PROCEDURE

Total pancreatectomy

Patients randomized to receive total pancreatectomy at the time of transection of the pancreas will undergo completion total pancreatectomy according to each Institution's operative standards.

PROCEDURE

Pancreatic anastomosis

Patients randomized to receive pancreatic anastomosis at the time of transection of the pancreas will undergo pancreatico-jejunosomy or pancreatico-gastrostomy according to each Institution's operative standards.

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Roberto Salvia, MD, PhD · Azienda Ospedaliera Universitaria Integrata di Verona

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2023-12-31
Completion
2025-12-31

Countries

  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05212350 on ClinicalTrials.gov