Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

NCT04469504 | Recruiting

• 2 other identifiers: 2017_062019-A00632-55
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia; Pancreatic Cancer

Keywords

morbimortality; Prehabilitaion; pancreatic surgery; cephalic duodenopancreatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of Severe postoperative complications

  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

  at 30 days

• Satisfaction questionnaire by EVAN-G

  at 30 days

Study Arms (2)

PREHAB

EXPERIMENTAL

Other: Prehabilitation program

control group

ACTIVE COMPARATOR

Dietary Supplement: Oral Impact

Interventions

Prehabilitation program OTHER

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

PREHAB

Oral Impact DIETARY_SUPPLEMENT

perioperative immunonutrition by ORAL IMPACT

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing pancreaticoduodenectomy for cancer
• Sarcopenic status

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Groupement Interrégional de Recherche Clinique et d'Innovation: collaborator
• Santelys Association: collaborator

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Mehdi ELAMRANI, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehdi ELAMRANI, MD

CONTACT

0320444465; mehdi.elamrani@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: May 17, 2022
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)