Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma

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.

Study Overview

• Status: Recruiting
• Conditions: Perihilar Cholangiocarcinoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Julie Leclerc, MD; Phone Number: 0383154207; Email: j.leclerc@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54500
    • Recruiting
    • CHRU de Nancy
    • Contact: Julie Leclerc; Phone Number: 0383154207; Email: j.leclerc@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgical peri hilar cholangiocarcinoma at Nancy University Hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non curative surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	01/01/2003 to 04/01/2021
Disease Free Survival	01/01/2003 to 04/01/2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Post operative complications : Dindo-Clavien > or = 3	01/01/2003 to 04/01/2021

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Ahmet Ayav, PhD, Central Hospital, Nancy, France

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Lancet. 2019 Jun 29;393(10191):2590.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (ACTUAL): April 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: nutritional status; surgery; sarcopenia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: 2021PI058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No