Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma

• Conditions: Perihilar Cholangiocarcinoma
• Interventions: Other: Nutritional evaluation

• Registration Number: NCT04846192
• Lead Sponsor: Central Hospital, Nancy, France

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.

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 Timeline

• Status Verified: 2021-03
• Study Start: 2021-04
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Last Update Submitted: 2021-04-12
• Study First Posted: 2021-04-15
• Last Update Posted: 2021-04-15
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Non curative surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Nutritional evaluation	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	01/01/2003 to 04/01/2021
Disease Free Survival	01/01/2003 to 04/01/2021

Secondary Outcome Measures

Name	Time	Method
Morbidity	01/01/2003 to 04/01/2021	Post operative complications : Dindo-Clavien \> or = 3

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France