NCT03574116

Brief Summary

The study of sarcopenia is a subject that is the subject of numerous research and publications, particularly because of its link with a poor prognosis for many cancers. In an article published by the digestive surgery team, the role of feeding jejunostomy has been demonstrated: it allowed more patients to reach the 2nd stage of surgery and a better tolerance of chemotherapy. Investigators wanted to study retrospectively the impact of feeding jejunostomy on radiological sarcopenia. Is the positive effect of jejunostomy in gastric cancers associated with a decrease in sarcopenia?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 31, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 6, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

May 31, 2018

Last Update Submit

July 4, 2018

Conditions

Keywords

Sarcopeniajejunostomyoesogastric adenocarcinomascanography

Outcome Measures

Primary Outcomes (1)

  • Evaluate muscle status by CT evaluation of sarcopenia in patients

    Evaluate the impact of feeding jejunostomy in patients with gastric cancer

    24 hour after the realization of the MRI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject with Stage IB Gastric Cancer and having benefited from the placement or not of a feeding jejunostomy and a control CT performed at the HUS, after the end of the courses of chemotherapy and / or before the surger

You may qualify if:

  • Age 18-80 years
  • Sex: H or F
  • Subject giving their consent for their participation
  • Gastric cancers
  • stage\> IB
  • whether or not a feeding jejunostomy
  • CT scan performed at the HUS, after the end of the courses of chemotherapy and / or before the surgery.

You may not qualify if:

  • antecedent level L3 surgery,
  • psoas hematoma
  • No CT performed at HUS at the end of chemotherapy and / or before surgery
  • Impossibility of giving the subject informed information
  • Subject under the protection of justice
  • Subject under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Imagerie 1

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 29, 2018

Study Start

May 31, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

July 6, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations