Clinical trial NCT04846192: Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma
Official title: Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perihilar Cholangiocarcinoma
Keywords: sarcopenia
nutritional status
surgery
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical peri hilar cholangiocarcinoma at Nancy University Hospital

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non curative surgery

Primary outcomes:
measure: Overall Survival
timeFrame: 01/01/2003 to 04/01/2021
measure: Disease Free Survival
timeFrame: 01/01/2003 to 04/01/2021
Secondary outcomes:
measure: Morbidity
timeFrame: 01/01/2003 to 04/01/2021
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Ahmet Ayav, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.