HYPPO: Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06126601
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 14.5
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief Summary

Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date.

Therefore the overall study aims are:

• To prospectively evaluate the incidence and assess the clinical value of biochemical changes for the postoperative course.

• To confirm and improve the definition and classification of postpancreatectomy acute pancreatitis (PPAP) of the International Study Group of Pancreatic Surgery (ISGPS) and to provide knowledge for effective early management of complications.

Condition or Disease	Intervention/Treatment	Phase
Pancreatectomy; Hyperamylasemia; Pancreatitis, Acute	Other: Pancreatectomy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
• Actual Study Start Date: Jul 18, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Outcome Measures

Primary Outcome Measures

1. Incidence of PPAP (Postpancreatectomy Acute Pancreatitis) [90 days after surgery]

   Incidence after pancreasresection (pancreatoduodenectomy and distal pancreas resection) according to the definition of ISGPS (International Study Group on Pancreatic Surgery)

2. Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia) [90 days after surgery]

   Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI)

Secondary Outcome Measures

1. Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy [90 days after surgery]

   Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia

2. Correlation between hyperamylasemia and radiological findings for pancreatitis [90 days after surgery]

   Incidence of pancreatitis according to the CT scan postoperatively

3. Incidence of postoperative mortality [90 days after surgery]

   Postoperative death after complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery	Dresden		Germany	01307

Sponsors and Collaborators

• Technische Universität Dresden

Investigators

• Principal Investigator: Marius Distler, Prof. Dr., University Hospital Dresden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Technische Universität Dresden
• ClinicalTrials.gov Identifier: NCT06126601
• Other Study ID Numbers: VTG-14; DRKS00031860
• First Posted: Nov 13, 2023
• Last Update Posted: Nov 13, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatitis; Hyperamylasemia

Study Results

No Results Posted as of Nov 13, 2023