Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer (PSOAS)

Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors

Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.

The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Sarcopenia
• Intervention / Treatment: Other: Prehabilitation program; Dietary supplement: Oral Impact

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehdi ELAMRANI, MD; Phone Number: +33 0320444465; Email: mehdi.elamrani@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hop Claude Huriez Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing pancreaticoduodenectomy for cancer
• Sarcopenic status

Exclusion Criteria:

• Age younger than 18 years
• Medical contraindications including cardiovascular disease or clinically significant vascular disease
• Physical inability to exercise
• Emergent surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Dietary supplement: Oral Impact; perioperative immunonutrition by ORAL IMPACT
Experimental: PREHAB	Other: Prehabilitation program; 4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative severe pancreatic fistula (Grade B and C)	Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)	at 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Severe postoperative complications	Grade > IIIa (Clavien-Dindo classification)	at 90 days
Overall survival		at 1 year and at 3 years
Program acceptance measure by Modified ACCEPT© questionnaire		at 30 days
Rate of program completion	self questionnaire to measure opinion with respect of rehabilitation program	at 30 days
Satisfaction questionnaire by EVAN-G	EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems.	at 30 days
Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)	French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index)	at 30 days
Quality of life by EORTC-QLQc30 scale	The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL.	at 1 month, 3 months, 6 months and at 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Santelys Association; Groupement Interrégional de Recherche Clinique et d'Innovation
• Investigators: Principal Investigator: Mehdi ELAMRANI, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pancreatic surgery; morbimortality; Prehabilitaion; cephalic duodenopancreatectomy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pancreatic Neoplasms; Sarcopenia
• Other Study ID Numbers: 2017_06; 2019-A00632-55 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

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