Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma

NCT05631379 | Completed

• 1 other identifier: ERID-KSOPKR-0081/2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity.

Conditions

Retroperitoneal Sarcoma; Body Composition; Malnutrition; Sarcopenia; Sarcopenic Obesity; Myosteatosis

Outcome Measures

Primary Outcomes (3)

• Postoperative complications

  Complications graded by Clavien-Dindo Complication Classification System

  within 30 days after surgery

• Local recurrence rate

  A postoperative local recurrence will be defined by biopsy-proven or radiographic evidence of local recurrent disease

  From date of surgery until the date of first documented local progression assessed until June 2020

• Mortality

  Overall survival (OS) will be defined as the time between the date of the operation to the date of death from any cause or last follow-up (according to medical records and using telephone contacts)

  Length of survival after surgery until June 2020 (up to 130 months)

Secondary Outcomes (11)

• Length of hospital stay

  up to 90 days after surgery

• Major postoperative morbidity

  within 90 days after surgery

• Prevalence of preoperative malnutrition in primary RPS patients

  within 30 days before surgery

• Prevalence of preoperative sarcopenia in primary RPS patients

  within 30 days before surgery

• To evaluate the impact of skeletal muscle area (SMA) on the prognosis of patients with primary RPS

  through study completion, an average of 6 months

Study Arms (2)

All patients meeting inclusion criteria

All patients meeting inclusion criteria

Diagnostic Test: GLIM malnutrition criteria; Diagnostic Test: Prognostic Nutritional Index (PNI); Diagnostic Test: The high-sensitivity modified Glasgow prognostic score

Subgroup of patients with available preoperative CT/MRI scans

Subgroup of patients with available preoperative CT/MRI scans will be detected and body composition measurements will be assessed min order to detect nutrition-related syndromes

Other: Measurement of body composition with computed tomography (CT); Diagnostic Test: GLIM malnutrition criteria; Diagnostic Test: EWGSOP2 sarcopenia criteria; Diagnostic Test: ESPEN-EASO criteria for sarcopenic obesity; Diagnostic Test: Prognostic Nutritional Index (PNI); Diagnostic Test: The high-sensitivity modified Glasgow prognostic score

Interventions

Measurement of body composition with computed tomography (CT) OTHER

The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), muscle radiation attenuation (MRA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)

Subgroup of patients with available preoperative CT/MRI scans

GLIM malnutrition criteria DIAGNOSTIC_TEST

GLIM criteria (Global Leadership Initiative on Malnutrition) will be applied to assess malnutrition

All patients meeting inclusion criteria; Subgroup of patients with available preoperative CT/MRI scans

EWGSOP2 sarcopenia criteria DIAGNOSTIC_TEST

EWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia

Subgroup of patients with available preoperative CT/MRI scans

ESPEN-EASO criteria for sarcopenic obesity DIAGNOSTIC_TEST

The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) consensus criteria from 2018 will be applied to assess sarcopenic obesity

Subgroup of patients with available preoperative CT/MRI scans

Prognostic Nutritional Index (PNI) DIAGNOSTIC_TEST

Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count

All patients meeting inclusion criteria; Subgroup of patients with available preoperative CT/MRI scans

The high-sensitivity modified Glasgow prognostic score DIAGNOSTIC_TEST

The high-sensitivity modified Glasgow prognostic score (Hs-mGPS) is an inflammation-based score consisted of C-reactive protein level and serum albumin

All patients meeting inclusion criteria; Subgroup of patients with available preoperative CT/MRI scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020

You may qualify if:

• Patients aged above 18 years old
• Patients with primary localized RPS or pelvic sarcoma operated at Surgical Department of Institute of Oncology in Ljubljana

You may not qualify if:

• Patients with Gastrointestinal Stromal Tumors (GISTs) and Retroperitoneal desmoid-type fibromatosis (DF)
• Patients with visceral sarcomas (arising from visceral organ i.e., gastrointestinal, and genitourinary tracts sarcoma)
• Patients with benign retroperitoneal / pelvic tumors
• Patients with residual RPS operated at another hospital
• Patients with present recurrent, secondary, and metastatic RPS
• Unable to access patients' data

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (8)

• Previtali P, Fiore M, Colombo J, Arendar I, Fumagalli L, Pizzocri M, Colombo C, Rampello NN, Mariani L, Gronchi A, Codazzi D. Malnutrition and Perioperative Nutritional Support in Retroperitoneal Sarcoma Patients: Results from a Prospective Study. Ann Surg Oncol. 2020 Jun;27(6):2025-2032. doi: 10.1245/s10434-019-08121-0. Epub 2019 Dec 17.

  PMID: 31848820 BACKGROUND

• Stiller CA, Trama A, Serraino D, Rossi S, Navarro C, Chirlaque MD, Casali PG; RARECARE Working Group. Descriptive epidemiology of sarcomas in Europe: report from the RARECARE project. Eur J Cancer. 2013 Feb;49(3):684-95. doi: 10.1016/j.ejca.2012.09.011. Epub 2012 Oct 15.

  PMID: 23079473 BACKGROUND

• Arends J, Baracos V, Bertz H, Bozzetti F, Calder PC, Deutz NEP, Erickson N, Laviano A, Lisanti MP, Lobo DN, McMillan DC, Muscaritoli M, Ockenga J, Pirlich M, Strasser F, de van der Schueren M, Van Gossum A, Vaupel P, Weimann A. ESPEN expert group recommendations for action against cancer-related malnutrition. Clin Nutr. 2017 Oct;36(5):1187-1196. doi: 10.1016/j.clnu.2017.06.017. Epub 2017 Jun 23.

  PMID: 28689670 BACKGROUND

• Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.

  PMID: 30181091 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 BACKGROUND

• Donini LM, Busetto L, Bischoff SC, Cederholm T, Ballesteros-Pomar MD, Batsis JA, Bauer JM, Boirie Y, Cruz-Jentoft AJ, Dicker D, Frara S, Fruhbeck G, Genton L, Gepner Y, Giustina A, Gonzalez MC, Han HS, Heymsfield SB, Higashiguchi T, Laviano A, Lenzi A, Nyulasi I, Parrinello E, Poggiogalle E, Prado CM, Salvador J, Rolland Y, Santini F, Serlie MJ, Shi H, Sieber CC, Siervo M, Vettor R, Villareal DT, Volkert D, Yu J, Zamboni M, Barazzoni R. Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement. Obes Facts. 2022;15(3):321-335. doi: 10.1159/000521241. Epub 2022 Feb 23.

  PMID: 35196654 BACKGROUND

• Hou T, Guo T, Nie R, Hong D, Zhou Z, Zhang X, Liang Y. The prognostic role of the preoperative systemic immune-inflammation index and high-sensitivity modified Glasgow prognostic score in patients after radical operation for soft tissue sarcoma. Eur J Surg Oncol. 2020 Aug;46(8):1496-1502. doi: 10.1016/j.ejso.2020.05.026. Epub 2020 Jun 11.

  PMID: 32576479 BACKGROUND

• Yang Z, Zhang B, Hou L, Xie Y, Cao X. Pre-operative prognostic nutritional index predicts the outcomes for triple-negative breast cancer. Tumour Biol. 2014 Dec;35(12):12165-71. doi: 10.1007/s13277-014-2524-6. Epub 2014 Aug 30.

  PMID: 25172099 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Sarcopenia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Manuel Ramanović, M.D.

  Institute of Oncology Ljubljana, Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: December 2, 2022
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

SL (1)