Effect of enzyme therapy on patients after pancreatic surgery
The Effect of PERT on Postoperative Complications and Physiological Status in Patients Undergoing Pancreaticoduodenectomy
PHASE4 · Ruijin Hospital · NCT06119880
This study tests whether pancreatic enzyme therapy can help people recover better and improve their quality of life after pancreatic surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06119880 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of pancreatic enzyme replacement therapy (PERT) on patients undergoing pancreaticoduodenectomy. It is a prospective randomized controlled trial that aims to analyze postoperative complications, physiological status, and quality of life related to pancreatic exocrine dysfunction. The study also focuses on personalized nutrition management strategies based on individual risk factors to enhance recovery and nutritional outcomes after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 undergoing pancreaticoduodenectomy for benign or malignant conditions.
Not a fit: Patients with distant metastasis, tumor recurrence, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve postoperative recovery and quality of life for patients with pancreatic exocrine insufficiency.
How similar studies have performed: Other studies have shown promising results with pancreatic enzyme replacement therapy in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gender unlimited, 18-80 years old; * Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases; * Voluntary testing with informed consent. Exclusion Criteria: * Pregnant women and lactating women * Patients with distant metastasis based on tumor staging before surgery; * Tumor recurrence; * Refuse to sign the consent form.
Where this trial is running
Shanghai, Shanghai
- Shanghai Ruijin Hospital — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Weishen WANG, DR
- Email: peanutswey@hotmail.com
- Phone: 64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Exocrine Insufficiency, Pancreatic Enzyme Replacement Therapy, Pancreaticoduodenectomy