NCT04348084

Brief Summary

Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2009

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

9.8 years

First QC Date

April 14, 2020

Last Update Submit

April 15, 2020

Conditions

PDAC of the Body and the Tail of the PancreasCR- POPF

Keywords

Clinically relevant pancreatic fistulapancreatic leakpancreatic cancerleft pancreatectomydistal pancreatectomyoncologic outcomepancreatic cancer recurrence

Outcome Measures

Primary Outcomes (1)

  • impact of clinically relevant (CR-) POPF

    The primary aim of this study is to assess the impact of clinically relevant (CR-) POPF on patient disease specific survival (OS and DFS) after curative distal pancreatectomy.

    10 years

Secondary Outcomes (1)

  • identifying positive and negative prognostic factors

    10 years

Study Arms (2)

who developed POPF

Patients undergone curative distal pancreatectomy for PDAC who developed POPF

who did not develop POPF

Patients undergone curative distal pancreatectomy for PDAC who did not develop POPF

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) of the body and the tail of the pancreas, undergoing DP with curative intent, over a ten-year period (from January 2009 to December 2018) in twelve European Surgical Departments were retrospectively collected from a prospective implemented database.

You may qualify if:

  • \- patient with resectable pancreatic ductal adenocarcinoma (PDAC) of the body and the tail of the pancreas undergone surgery

You may not qualify if:

  • metastatic diseases (including para-aortic lymph nodes involvement)
  • PDAC arising from Intraductal Papillary Mucinous Neoplasms (IPMN)
  • resection for premalignant lesions including high-grade Pancreatic Intraepithelial Neoplasia (PanIN) or adenocarcinoma in situ (Tis)
  • histological diagnosis other than PDAC
  • all R2 resections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Leon P, Giannone F, Belfiori G, Falconi M, Crippa S, Boggi U, Menonna F, Al Sadairi AR, Piardi T, Sulpice L, Gardini A, Sega V, Chirica M, Ravazzoni F, Giannandrea G, Pessaux P, de Blasi V, Navarro F, Panaro F. The Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma of the Body and the Tail: A Multicenter Retrospective Cohort Analysis. Ann Surg Oncol. 2021 Jun;28(6):3171-3183. doi: 10.1245/s10434-020-09310-y. Epub 2020 Nov 6.

    PMID: 33156465DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Fabrizio PANARO, PhD

    UH MONTPELLIER

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 15, 2020

Study Start

January 30, 2009

Primary Completion

December 1, 2018

Study Completion

December 30, 2018

Last Updated

April 16, 2020

Record last verified: 2020-04

Locations

FR(1)