NCT05489419

Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.

Status unknown NA Last updated 5 August 2022

What this trial tests

NA trial testing Multimodal Prehabilitation in Pancreatic Neoplasms in 56 participants. Status unknown.

Timeline

1 January 2021

Primary endpoint
30 May 2023

30 May 2023

Quick facts

Lead sponsor	Hospital Clinic of Barcelona
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	56
Start date	1 January 2021
Primary completion	30 May 2023
Estimated completion	30 May 2023
Sites	1 location across Spain

Drugs / interventions tested

• Multimodal Prehabilitation

Conditions studied

• Pancreatic Neoplasms — all drugs for Pancreatic Neoplasms →
• Anesthesia — all drugs for Anesthesia →

Sponsor

Hospital Clinic of Barcelona

Who can join

Eligibility, any sex, with Pancreatic Neoplasms or Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Several studies in major abdominal surgery demonstrated that preoperative optimization of surgical patients through prehabilitation is associated with fewer postoperative complications. However, patients' response to preoperative optimization is unpredictable, and there are no studies confirming the real benefit in pancreatic surgery.

Aims: To assess the benefits of pre-rehabilitation in pancreatic surgery, and identify those factors associated with an effective optimization. Secondary aims: impact of prehabilitation on nutritional status, sarcopenia, quality of life, inflammation markers, postoperative complications and hospital stay compared to low-risk patients.

Design: An objective multimodal assessment will be performed on those patients who are candidates to pancreaticoduodenectomy (PD) to identify patients at high-risk of postoperative complications. These patients will undergo prehabilitation and response will be evaluated. Intervention:Multimodal Prehabilitation will include:

1. Physical and cardiopulmonary training followed by a personalized program according to basal aerobic capacity, patient circumstances and compliance, community-based and remote-controlled with information and communication technology (ICT).
2. Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes).
3. Treatment of anxiety and depression.

Subjects: 56 consecutive patients who are high-risk candidates (anaerobic threshold 11ml/kg/min at CPET) for PD recruited at Hospital Clinic of Barcelona. Postoperative variables will be compared to low-risk patients evaluated during the same study period.

Analysis:

The main variable will be aerobic capacity (VO2max, AT). Secondary variables (before and after the program) will be nutritional status, sarcopenia, quality of life, inflammation markers and immune response, hospital stay, complications, 90-days mortality and costs.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exercise and Nutrition Interventions for Prehabilitation in Hepato-Pancreato-Biliary Cancers: A Narrative Review.
   Christopher CN, Kang DW, Wilson RL, Gonzalo-Encabo P, et al · · 2023 · cited 13× · PMID 38140303 · DOI 10.3390/nu15245044