Actively Recruiting
Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
Led by Technische Universität Dresden · Updated on 2026-02-03
150
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who have undergone pancreatectomy to understand the role of postoperative hyperamylasemia (POH) as a predictor of complications after surgery. The study aims to assess biochemical changes after pancreatectomy and to improve the definition and classification of postpancreatectomy acute pancreatitis (PPAP) as established by the International Study Group of Pancreatic Surgery (ISGPS). This observational study seeks to provide insights for better early management of postoperative complications. Participants are patients who have undergone pancreatic resection for either malignant or benign diseases. Blood samples will be collected before surgery, during the operation at specific times, and postoperatively on days 1, 2, 3, 5, and 7 to measure amylase, lipase, and several other laboratory parameters including leucocytes, CRP, bilirubin, transaminases, and interleukin-6. Intraoperative collection of pancreas juice will also be analyzed. Patients will be followed during their hospital stay and at 3 and 6 months after discharge to record clinical outcomes such as complications and any need for rescue pancreatectomy. Throughout the study, participants will undergo multiple blood tests and clinical assessments to monitor their biochemical status and postoperative recovery. Researchers will evaluate the incidence of PPAP and the significance of biochemical changes within 90 days after surgery. Secondary measures include correlations of hyperamylasemia with rescue pancreatectomy, radiological findings, and postoperative mortality. Safety and patient outcomes will be closely monitored during the follow-up period extending up to six months post-discharge, with total participation lasting several months from surgery through follow-up visits.
CONDITIONS
Brief Title
Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay plus 7 days post-surgery
Participants undergo pancreatectomy surgery with blood samples taken before, during, and immediately after the operation. Postoperative blood samples are collected daily during hospital stay to monitor biochemical parameters and clinical outcomes.
Blood samples taken preoperatively, intraoperatively, and postoperatively on days 1, 2, 3, 5, and 7
Duration - Up to 6 months after discharge
Participants are monitored during their hospital stay and followed up at 3 and 6 months after discharge to assess clinical outcomes and safety.
Follow-up visits at 3 and 6 months post-discharge
Trial Site Locations
Total: 1 location
1
University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery
Dresden, Germany, 01307
Actively Recruiting
Research Team
O
Olga Radulova-Mauersberger, Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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