PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Insufficiency
• Interventions: Drug: PERT at discharge; Other: Standard of Care

• Registration Number: NCT05466838
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

After pancreas surgery, patients may develop pancreatic exocrine insufficiency (PEI). PEI can be treated with oral pancreatic enzyme replacement therapy (PERT). However, the diagnosis of PEI is difficult and the guidelines about when to start PERT after pancreas surgery are conflicting. This pilot study aims to determine the feasibility of implementing a large-scale clinical trial to definitively evaluate if starting PERT immediately after surgery can improve outcomes in patients undergoing pancreas surgery.

Detailed Description

After pancreas surgery, patients may develop pancreatic exocrine insufficiency (PEI). This occurs when there are not enough exocrine cells in the pancreas to release enzymes that help with food digestion. Potential symptoms may include bloating, cramping, large and foul-smelling bowel movements (steatorrhea), and other gastrointestinal symptoms like diarrhea, weight-loss, and malnutrition. PEI can be treated with oral pancreatic enzyme replacement therapy (PERT), for example CREON. Many studies have shown that treatment of PEI with PERT is safe, effective, and may improve quality of life, reduce weight loss, improve abdominal symptoms, and may improve overall survival. However, the diagnosis of PEI is difficult and the guidelines about when to start PERT after pancreas surgery are conflicting. This pilot study aims to determine the feasibility of implementing a large-scale clinical trial to definitively evaluate if starting PERT immediately after surgery can improve outcomes in patients undergoing pancreas surgery.

Participants will be recruited from Ontario hospitals using a two-step eligibility process (pre- and post-operatively) and randomized 1:1 to receive either standard of care or PERT plus standard of care. Outcome measures will be collected 1 and 3 months postoperatively.

Study Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-20
• Study Start: 2023-01-06
• Primary Completion: 2024-05-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

1. Adults aged >18 years
2. Willing and able to provide informed consent and/or have a substitute decision maker (SDM) provide informed consent on behalf of the participant
3. Planned PD for any indication AND, at randomization
4. PD performed
5. Discharge planned within 21 days of surgery

Exclusion Criteria

1. Contraindication to PERT including:

   1. Hypersensitivity to porcine protein, pancreatic enzymes or any excipients
   2. History of fibrosing colonopathy
   3. Unable to tolerate oral medication

2. Current use of PERT OR, at randomization

3. Use of PERT at the time of randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PERT plus Standard of Care	PERT at discharge	Initiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation
Standard of Care	Standard of Care	Standard of care (no PERT) until presentation of PEI symptoms.
PERT plus Standard of Care	Standard of Care	Initiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation

Primary Outcome Measures

Name	Time	Method
Completeness of dataset	3 months	Assessment of completeness of data, loss to follow-up and missing data and reasons for not being able to collect data
Proportion of patients screened who consent	Baseline	Each centre will keep a screening log of all patients who are scheduled to undergo an elective pancreaticoduodenectomy and perform pre-screening to determine eligibility. The number of eligible patients who are approached for and consent to participate, as well as the number of approached eligible patients who decline to participate (and reasons for declining) will be recorded and the proportions will be calculated
Proportion of patients screened who meet eligibility criteria	Baseline	Each centre will keep a screening log of all patients who are scheduled to undergo an elective pancreaticoduodenectomy and perform pre-screening to determine eligibility. The eligibility criteria that are unmet will be recorded, including the additional criteria for randomization. This will be used to calculate proportions.
Adherence to PERT	3 months	Recorded on participant's medication tracker and calculated as a percentage of expected vs. actual doses taken.
Adherence to PERT dosing guidelines	3 months	Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline
Resource requirement for definitive trial	Study completion (1.5 years)	Each site will complete a survey at the end of the trial to report the amount of time spent on study activities

Secondary Outcome Measures

Name	Time	Method
Weight loss	1 month, 3 months	Difference in weight (kg) from baseline
Change in Digestive Symptoms Scale from Baseline	1 month, 3 months	Measured using PAN26 quality of life questionnaire which specific to pancreatic cancer and must be administered in conjunction with QLQ-C30. Scores range from 0 to 100 and consist of functional scales and symptoms scales. A high score on the symptoms scales indicates a high level of symptomatology. A high score on the functional scales indicates a high level of functioning.
Change in Quality of Life from Baseline	1 month, 3 months	Measured using the QLQ-C30 quality of life questionnaires. QLQ-C30 is a validated questionnaire that assesses health-related quality of life (QoL) in cancer patients. Scores for both questionnaires range from 0 to 100 and consist of functional scales and symptoms scales. A high score on the symptoms scales indicates a high level of symptomatology. A high score on the functional scales indicates a high level of functioning.

Trial Locations

Locations (6)

Hamilton Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada