NCT02909296

Brief Summary

The pancreatic surgery causing some pancreatic collections. And in a number of case, this surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage. The endoscopic care of the treatment of pancreatic collections post-surgery is not yet standardized. After failure of the medical treatment, the drainage of collections by echo-endoscopy was described. There are not much series on this specific subject. Only 2 series contain more than 20 patients with 31 patients for the most important. The timing and the technical choice of the endoscopic treatment as well as the long-term follow-up are not clear. The purpose of this study is to estimate the success and the complications of the endoscopic drainage by echo-endoscopy according to the techniques of drainage and the timing of the endoscopic treatment. The not estimated long-term follow-up will be also considered.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

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

April 1, 2007

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

9 years

First QC Date

September 16, 2016

Last Update Submit

September 16, 2016

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Long-term evaluation of the risk of relapse

    Up to 6 month

  • Timing of endoscopic drainage

    Up to 3 month

Secondary Outcomes (1)

  • Immediate efficiency

    Immediate post operative intervention

Other Outcomes (1)

  • Post surgery complications

    Up to 1 month

Interventions

Endoscopic drainagePROCEDURE

Eligibility Criteria

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

Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically

You may qualify if:

  • Age \> 18 years
  • Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically

You may not qualify if:

  • Contraindication surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • CAILLOL Fabrice, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 21, 2016

Study Start

April 1, 2007

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share