NCT04846192

Brief Summary

Curative treatment of peri hilar cholangiocarcinomas is R0 surgery and require major hepatectomy with biliary tract resection. These complexe procedures can lead to high morbidity and mortality. A severe alteration of nutritional status before the surgery might be a poor prognosis for survival.

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 Apr 2021

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

Study Start

First participant enrolled

April 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

April 12, 2021

Last Update Submit

April 12, 2021

Conditions

Keywords

sarcopenianutritional statussurgery

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    01/01/2003 to 04/01/2021

  • Disease Free Survival

    01/01/2003 to 04/01/2021

Secondary Outcomes (1)

  • Morbidity

    01/01/2003 to 04/01/2021

Study Arms (1)

Patients

Other: Nutritional evaluation

Interventions

Collecting existing data on pre operative nutritional status and outcomes after surgery

Patients

Eligibility Criteria

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

Surgical peri hilar cholangiocarcinoma at Nancy University Hospital

You may qualify if:

  • Surgical peri hilar cholangiocarcinoma from 01/01/2003 to 04/01/2021 at Nancy University Hospital

You may not qualify if:

  • Non curative surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (4)

  • Otsuji H, Yokoyama Y, Ebata T, Igami T, Sugawara G, Mizuno T, Nagino M. Preoperative sarcopenia negatively impacts postoperative outcomes following major hepatectomy with extrahepatic bile duct resection. World J Surg. 2015 Jun;39(6):1494-500. doi: 10.1007/s00268-015-2988-6.

    PMID: 25651963BACKGROUND
  • Golse N, Nunez J, Mazzotta A, Cano L, Bergeat D, Sulpice L, Jeddou H, Abdelrafee A, Sa Cunha A, Cherqui D, Adam R, Boudjema K, Vibert E. Personalized Preoperative Nomograms Predicting Postoperative Risks after Resection of Perihilar Cholangiocarcinoma. World J Surg. 2020 Oct;44(10):3449-3460. doi: 10.1007/s00268-020-05618-8.

    PMID: 32474628BACKGROUND
  • Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.

    PMID: 31171417BACKGROUND
  • Yugawa K, Itoh S, Kurihara T, Yoshiya S, Mano Y, Takeishi K, Harada N, Ikegami T, Soejima Y, Mori M, Yoshizumi T. Skeletal muscle mass predicts the prognosis of patients with intrahepatic cholangiocarcinoma. Am J Surg. 2019 Nov;218(5):952-958. doi: 10.1016/j.amjsurg.2019.03.010. Epub 2019 Mar 14.

MeSH Terms

Conditions

Klatskin TumorSarcopenia

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Ahmet Ayav, PhD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Leclerc, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 15, 2021

Study Start

April 1, 2021

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

April 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations