Evaluating the effects of high amylase levels after pancreas surgery on recovery and safety
Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
This study looks at how high levels of a certain enzyme after pancreas surgery affect recovery and safety for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Locations | 1 site (Dresden) |
| Trial ID | NCT06126601 on ClinicalTrials.gov |
What this trial studies
This observational study aims to prospectively evaluate the incidence of postoperative hyperamylasemia (POH) in patients who have undergone pancreatectomy and its clinical implications on postoperative outcomes. By analyzing biochemical changes and correlating them with other laboratory parameters, the study seeks to enhance the understanding of postpancreatectomy acute pancreatitis (PPAP) and improve its classification according to international standards. The findings could lead to better management strategies for complications arising after pancreatic surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 undergoing pancreatic resection for both malignant and benign conditions.
Not a fit: Patients undergoing necrosectomy for acute pancreatitis or those who are less than 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative care and outcomes for patients undergoing pancreatectomy.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated that monitoring biochemical markers can be crucial in managing postoperative complications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing pancreatic resection for malignant and benign disease with or without pancreatic anastomosis * Patients aged 18-85 years * Willingness to participate as demonstrated by giving a written informed consent. Exclusion Criteria: * Necrosectomy (endoscopic or open) for primary acute pancreatitis or within laparotomy * Age less than 18 years * Surgical drainage procedures without pancreatic resection (cystojejunostomy for pancreatic pseudocysts) * One-stage total pancreatectomy * Missing written consent
Where this trial is running
Dresden
- University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery — Dresden, Germany (Recruiting)
Study contacts
- Principal investigator: Marius Distler, Prof. Dr. — University Hospital Dresden
- Study coordinator: Olga Radulova-Mauersberger, Dr. med.
- Email: studienzentrum-vtg@ukdd.de
- Phone: +49 351 458-0
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.