Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

Pancreatic Cancer Clinical Trial

— PSOAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04469504
• Other study ID #: 2017_06
• Secondary ID: 2019-A00632-55
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: May 2028

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Mehdi ELAMRANI, MD
• Phone: 0320444465
• Email: mehdi.elamrani[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Sarcopenia

Intervention

Other:
• Prehabilitation program
4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support

Dietary Supplement:
• Oral Impact
perioperative immunonutrition by ORAL IMPACT

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Groupement Interrégional de Recherche Clinique et d'Innovation, Santelys Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Severe postoperative complications	Grade > IIIa (Clavien-Dindo classification)	at 90 days
Secondary	Overall survival		at 1 year and at 3 years
Secondary	Program acceptance measure by Modified ACCEPT© questionnaire		at 30 days
Secondary	Rate of program completion	self questionnaire to measure opinion with respect of rehabilitation program	at 30 days
Secondary	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
Secondary	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
Secondary	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