Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease

Pancreatic Ductal Adenocarcinoma Clinical Trial

— SIPUP  

Official title:

A Pilot Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770117
• Other study ID #: B00101
• Status: Completed
• Start date: October 4, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: January 2021
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess whether prehabilitation supervised by an appropriate multimodality team improves indices of sarcopenia in patients scheduled to undergo pancreatoduodenectomy.

Description:

Cachexia is a hallmark feature of pancreatic cancer. Patients with features of cachexia have worse clinical outcomes. This includes a reduction in quality of life, reduced tolerance of therapy and a poorer prognosis . Specifically related to patients undergoing pancreatic surgery clinical evidence of cachexia is associated with higher perioperative complication rates. Sarcopenia, defined as a decreased muscle mass independent of fat mass, is a feature of the cachexia associated with pancreatic cancer. Patients with sarcopenia have progressive and generalised reduced muscle mass and function In patients undergoing surgery for pancreatic cancer sarcopenia has been associated with increased rates of complication and worse survival . Treatment of sarcopenia is difficult but includes nutritional support and pancreatic enzyme replacement therapy (PERT) aimed at reducing malabsorption. Whether measures aimed at combating sarcopenia can improve clinical outcomes following pancreatic surgery is currently unknown.

Prehabilitation is a multimodal therapeutic regimen aimed at improving the overall physical condition of patients prior to surgery with the intention of reducing the incidence of perioperative complications. Emerging evidence suggests that exercise prior to surgery for high risk patients scheduled to undergo major abdominal surgery improves aerobic capacity and can reduce the incidence of perioperative complications . The impact of prehabilitation undertaken prior to pancreatic surgery on perioperative complication rates has not yet been investigated.

The aim of this study is to assess whether prehabilitation supervised by an appropriate multimodality team improves indices of sarcopenia in patients scheduled to undergo pancreatoduodenectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

Inclusion criteria

1. Patients treated by pancreatic resection

2. Surgery for malignancy

3. Patients aged over 16

4. CT scans available for assessment

Exclusion criteria

1. Patients scheduled for fast-track pancreatic resection as part of the jaundice pathway

2. Aged under 16

3. Patients not undergoing pancreatic resection

Related Conditions & MeSH terms

• Pancreatic Ductal Adenocarcinoma
• Sarcopenia

Intervention

Procedure:
• Prehabilitation
Participants who underwent Prehabilitation will have their CT scans analysed.
• Standard Procedure
Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester	Gtr Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT Scan Comparison	CT Scans from patients which underwent the Prehabilitation & standard care will be compared.	Within last 5 years.