Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 166
- 试验地点
- 6
- 主要终点
- Completeness of dataset
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged >18 years
- •Willing and able to provide informed consent and/or have a substitute decision maker (SDM) provide informed consent on behalf of the participant
- •Planned PD for any indication AND, at randomization
- •PD performed
- •Discharge planned within 21 days of surgery
排除标准
- •Contraindication to PERT including:
- •Hypersensitivity to porcine protein, pancreatic enzymes or any excipients
- •History of fibrosing colonopathy
- •Unable to tolerate oral medication
- •Current use of PERT OR, at randomization
- •Use of PERT at the time of randomization
研究组 & 干预措施
PERT plus Standard of Care
Initiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation
干预措施: PERT at discharge (Drug)
PERT plus Standard of Care
Initiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation
干预措施: Standard of Care (Other)
Standard of Care
Standard of care (no PERT) until presentation of PEI symptoms.
干预措施: Standard of Care (Other)
结局指标
主要结局
Completeness of dataset
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 3 months
Recorded on participant's medication tracker and calculated as a percentage of expected vs. actual doses taken.
Adherence to PERT dosing guidelines
时间窗: 3 months
Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline
Resource requirement for definitive trial
时间窗: 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
次要结局
- Weight loss(1 month, 3 months)
- Change in Digestive Symptoms Scale from Baseline(1 month, 3 months)
- Change in Quality of Life from Baseline(1 month, 3 months)