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Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT04846192
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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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.

Condition or disease Intervention/treatment
Perihilar Cholangiocarcinoma Other: Nutritional evaluation

Detailed Description:

Peri hilar cholangiocarcinomas are rare tumors, which when diagnosed at the resectable stage, require major hepatic resection associated with biliary reconstruction. These are complex procedures with a high morbidity and mortality, mainly due to postoperative hepatic failure and sepsis.

These patients undergo optimization of liver function with portal embolization according to the volume of the future remaining liver and preoperative biliary drainage. On top of technical challenges of the surgery, the patients usually present a significant alteration of the general condition at the time of diagnosis, with denutrition that can be severe. The importance of evaluating the preoperative nutritional status in the context of oncological surgery is increasingly recognized in the literature. Different nutritional scores exist such as the CONUT score, PNI, or the evaluation of sarcopenia on imaging examinations and have shown an impact on morbi-mortality in liver surgery.

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients Other: Nutritional evaluation
Collecting existing data on pre operative nutritional status and outcomes after surgery


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 01/01/2003 to 04/01/2021 ]
  2. Disease Free Survival [ Time Frame: 01/01/2003 to 04/01/2021 ]

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 01/01/2003 to 04/01/2021 ]
    Post operative complications : Dindo-Clavien > or = 3


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical peri hilar cholangiocarcinoma at Nancy University Hospital
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non curative surgery
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846192


Contacts
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Contact: Julie Leclerc, MD 0383154207 j.leclerc@chru-nancy.fr

Locations
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France
CHRU de Nancy Recruiting
Vandœuvre-lès-Nancy, France, 54500
Contact: Julie Leclerc    0383154207    j.leclerc@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Ahmet Ayav, PhD Central Hospital, Nancy, France
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04846192    
Other Study ID Numbers: 2021PI058
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
sarcopenia
nutritional status
surgery
Additional relevant MeSH terms:
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Cholangiocarcinoma
Klatskin Tumor
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms