The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy
NCT ID: NCT06119880
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2023-11-01
2025-12-31
Brief Summary
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1. The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy;
2. The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy;
3. The personalized full process nutrition management strategies based on risk factor stratification.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PERT Group
After surgery, resume diet and begin receiving standard PERT treatment (2 capsules per meal, 1 capsule per snack, taken with meals, starting at a dose of 40000 to 50000 units of lipase) for 8 weeks.
Pancreatin Enteric-coated Capsules
pancreatic enzyme replacement therapy
Placebo Group
Follow the routine treatment plan for pancreatic tumors during the perioperative period.
Routine treatment plan
Routine treatment plan without PERT
Interventions
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Pancreatin Enteric-coated Capsules
pancreatic enzyme replacement therapy
Routine treatment plan
Routine treatment plan without PERT
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases;
* Voluntary testing with informed consent.
Exclusion Criteria
* Patients with distant metastasis based on tumor staging before surgery;
* Tumor recurrence;
* Refuse to sign the consent form.
18 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Weishen WANG
Principal Investigator
Locations
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Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HBP-RCT-004
Identifier Type: -
Identifier Source: org_study_id
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