Preoperative supplementation of pancreatic enzymes for Whipple’s procedure for malignancies (PREPARE).

Change in nutritional state and postoperative outcome following preoperative introduction of nutritional supplements and pancreatic enzymes in patients undergoing Whipple’s procedure for pancreatic cancer (PREPARE): a randomised controlled trial. - Preoperative pancreatic enzyme supplementation in Whipple’s procedure

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000242-19-GB

Enrollment

128

Registered

2018-06-30

Start date

2018-04-13

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing Whipple’s procedure for pancreatic head tumours MedDRA version: 20.0 Level: PT Classification code 10033644 Term: Pancreaticoduodenectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Creon 25000 Product Name: Creon 25000 Pharmaceutical Form: Capsule, hard INN or Proposed INN: pancreatin PhEur 300 mg Other descriptive name: Creon 25000 Concentration unit: mg milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients with operable pancreatic head or periampullary tumours will be approached for this study. Patients are considered operable after discussion in the Hepatobiliary Pancreatic multidisciplinary meeting. Patients are considered operable in the absence of any distant metastasis and/or invasion of the superior meseteric vein and artery. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Exclusion criteria 1- Cholangitis / infection requiring hospitalisation. 2- Previous chemotherapy for this malignancy. 3- Severe gastric outlet obstruction (stenosis of the duodenum due to tumour growth) defined as vomiting, nausea and/or oral intake less than one /day. 4- Patients with known malnutrition not related to the pancreatic cancer (anorexia, mal absorption). 5- Vulnerable patients (Patients who are unable to give consent). 6- Less than 2 weeks between purported start of nutritional supplementation with or without pancreatic enzyme supplements and the date of pancreatic resection. 7- Hypersensitivity to Pancreatin of porcine origin or to any of the excipients.

Design outcomes

Primary

Measure	Time frame
Main Objective: Study question: Do preoperative nutritional supplements and pancreatic enzymes have an impact on postoperative outcomes in patients undergoing a Whipples procedure for pancreatic head tumours? ;Secondary Objective: 1. What is the effect of nutritional assessment and support (nutritional supplements, and pancreatic enzymes replacement) on patients’ postoperative outcomes in terms of morbidity and mortality? 2. What is the effect of nutritional assessment and support (nutritional supplements, and pancreatic enzymes replacement) in improving patients’ preoperative nutritional status compared to nutritional supplementation only? 3. Does this change of practice lead to any improvement of patients’ preoperative nutritional status?;Primary end point(s): The impact of enzymes supplements on patient’s postoperative outcome (morbidity (severe complications) and mortality) in patients undergoing Whipple’s procedure for pancreatic tumours are the primary end points of this study. Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery. A severe complication is defined as any Clavien-Dindo grade 3-5 complication, (leading to an additional invasive intervention or re-laparotomy with subsequent prolonged hospital stay or death (all cause mortality)) reference Ann Surg. 2004 August; 240(2): 205–213, or readmission for disease related morbidity morbidity 6 weeks after surgery. A comprehensive list of postoperative complications is given in the protocol. ;Timepoint(s) of evaluation of this end point: Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery.	—

Measure

Time frame

Main Objective: Study question: Do preoperative nutritional supplements and pancreatic enzymes have an impact on postoperative outcomes in patients undergoing a Whipples procedure for pancreatic head tumours? ;Secondary Objective: 1. What is the effect of nutritional assessment and support (nutritional supplements, and pancreatic enzymes replacement) on patients’ postoperative outcomes in terms of morbidity and mortality? 2. What is the effect of nutritional assessment and support (nutritional supplements, and pancreatic enzymes replacement) in improving patients’ preoperative nutritional status compared to nutritional supplementation only? 3. Does this change of practice lead to any improvement of patients’ preoperative nutritional status?;Primary end point(s): The impact of enzymes supplements on patient’s postoperative outcome (morbidity (severe complications) and mortality) in patients undergoing Whipple’s procedure for pancreatic tumours are the primary end points of this study. Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery. A severe complication is defined as any Clavien-Dindo grade 3-5 complication, (leading to an additional invasive intervention or re-laparotomy with subsequent prolonged hospital stay or death (all cause mortality)) reference Ann Surg. 2004 August; 240(2): 205–213, or readmission for disease related morbidity morbidity 6 weeks after surgery. A comprehensive list of postoperative complications is given in the protocol. ;Timepoint(s) of evaluation of this end point: Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery.

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Secondary

Measure	Time frame
Secondary end point(s): 1- Hospital stay 2- Number of (invasive) diagnostic procedures 3- Change in nutritional status assessed by changes in: Weight, BMI, SGA, serum albumin, cholesterol HDL, total protein, transferrin, LDH, and variations in SGA, bioelectrical impedance and hand grip assessment. 4- QoL variation over time ;Timepoint(s) of evaluation of this end point: Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery.	—

Measure

Time frame

Secondary end point(s): 1- Hospital stay 2- Number of (invasive) diagnostic procedures 3- Change in nutritional status assessed by changes in: Weight, BMI, SGA, serum albumin, cholesterol HDL, total protein, transferrin, LDH, and variations in SGA, bioelectrical impedance and hand grip assessment. 4- QoL variation over time ;Timepoint(s) of evaluation of this end point: Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery.

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Countries

United Kingdom

Contacts

Public ContactSanne Lof

University Hospital Southampton

sanne.lof@uhs.nhs.uk07483236361

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026