Enhancing Fitness Before Pancreatic Surgery

Pancreatic Cancer Clinical Trial

— MedEx  

Official title:

A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940067
• Other study ID #: 197169
• Status: Completed
• Phase: N/A
• Start date: March 28, 2017
• Est. completion date: August 20, 2018

Study information

• Verified date: August 2018
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.

Description:

Pancreatic surgery is high risk. The injury associated with surgery causes a stress response, comprising a variety of hormonal and metabolic effects. Patients undergoing pancreatic surgery experience one of the largest stress responses. Prehabilitation is the process of enhancing an individual's fitness, thereby improving tolerance to an upcoming physiological stress such as surgery. Studies involving prehabilitation have been shown to improve recovery after surgery and reduce complication rates. There are currently no published reports of prehabilitation involving patients undergoing pancreatic surgery. This research study will explore the effect of prehabilitation in these patients.

Patients with pancreatic disease are some of the least fit surgical candidates due to the disease process. Exercise training can improve physical fitness before elective abdominal surgery and nutritional supplementation can also influence clinical course via different mechanisms. Patients with pancreatic disease are often malnourished for several reasons. We propose a multimodal approach to prehabilitation involving dietary and exercise interventions during a four-week period preceding elective surgery. Core data will be collected from cardiopulmonary exercise tests and blood tests (to assess insulin sensitivity), before and after prehabilitation. Secondary outcomes such as length of stay and complications will also be measured postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 20, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Elective pancreatic resection

Exclusion Criteria:

Contraindication to cardiopulmonary exercise testing: unstable cardiac disease, lower limb dysfunction Emergency surgery Ischaemic ECG during cardiopulmonary exercise test Allergy to fish oil or olive oil

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• MedEx
A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery

Locations

Country	Name	City	State
United Kingdom	MATTU, Royal Surrey County Hospital	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust	University of Surrey

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Dunne DF, Jack S, Jones RP, Jones L, Lythgoe DT, Malik HZ, Poston GJ, Palmer DH, Fenwick SW. Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg. 2016 Apr;103(5):504-12. doi: 10.1002/bjs.10096. Epub 2016 Feb 11. — View Citation

Sato H, Carvalho G, Sato T, Lattermann R, Matsukawa T, Schricker T. The association of preoperative glycemic control, intraoperative insulin sensitivity, and outcomes after cardiac surgery. J Clin Endocrinol Metab. 2010 Sep;95(9):4338-44. doi: 10.1210/jc.2010-0135. Epub 2010 Jul 14. — View Citation

Snowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak power - measured using cardiopulmonary exercise testing	cardiopulmonary fitness	Change in peak power between start and end of prehabilitation (4 weeks)
Secondary	Insulin sensitivity - measured using the insulin clamp test	insulin sensitivity	Change in insulin sensitivity between start and end of prehabilitation (4 weeks)
Secondary	Length of stay	Recovery	From date of operation until date of discharge
Secondary	Complication rate	Morbidity	From date of operation until date of discharge
Secondary	Sleep	Sleep Quality	Change in sleep quality between start and end of prehabilitation (4 weeks)
Secondary	Fatigue	Fatigue Levels	Change in fatigue levels between start and end of prehabilitation (4 weeks)
Secondary	Well-being	Sense of Well-being	Change in well-being scores between start and end of prehabilitation (4 weeks)