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Prevention of CR-POPF in PD With the Technique of Connexion the Pancreatic Duct to Jejunum Stented (CONDUCTJE-ST).

NCT04898517 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-05-26

No results posted yet for this study

Summary

Objective: To assess the efficacy of the "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)" technique to prevent clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy (PD).

Summary Background Data: CR-POPF remains the most determining cause of morbidity and mortality after PD. The incidence of CR-POPF (grades B and C, ISGPS) is around 20% and is a potential source of severe secondary complications that are associated with a mortality of up to 40%.

Methods: A prospective pilot study included 50 consecutive patients who underwent PD with the CONDUCTJE-ST technique, the steps of which are described, performed by the same surgical team from January 2018 to February 2020. No patient received prophylactic or therapeutic somatostatin or its analogues. The primary endpoint was the incidence of CR-POPF. Secondary endpoints were postoperative mortality and morbidity, hospital course and during the first year of follow-up.

In a prospective study we have evaluated a "novel" technique, modification of the preexisting ones, for the reconstruction of the digestive continuity of the corporocaudal remnant in the PD, termed "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)", applicable to any type of pancreatic remnant, regardless of its texture and the diameter of the main pancreatic duct. The study was planned with the objective of achieving a significant reduction in the incidence of CR-POPF, so that CONDUCTJE-ST could be considered as a surgical procedure of choice in the management of the pancreatic remnant in PD.

Conditions

  • Pancreas Disease
  • Fistula Pancreatic

Interventions

PROCEDURE

Pancreaticoduodenectomy with the CONDUCTJE-ST technique

The termed technique "connexion pancreatic duct to the jejunum stented" (CONDUCTJE-ST) in pancreaticoduodenectomy is a novel technique, modification of the pre-existing ones, whose effectiveness lies in the fact that it is not an anastomosis in the strict sense but rather a simple connection for restoring pancreatic juice flow from the pancreatic remnant towards the intestine.

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria Aragón

    lead OTHER

Principal Investigators

  • Francisco A. García-Gil, MD · Instituto de Investigación Sanitaria Aragón

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-02-01
Completion
2021-02-28

Countries

  • Spain

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 NCT04898517 on ClinicalTrials.gov