Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler

Launched by UNIVERSITY HOSPITAL HEIDELBERG · Jan 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how often patients develop a condition called postoperative pancreatic fistula (POPF) after having a surgery called distal pancreatectomy (DP). This surgery involves removing part of the pancreas, and the trial specifically uses a device called the AEON™ Endostapler. The study will include 110 patients and aims to gather information that could help surgeons improve techniques, reduce complications, and enhance overall health outcomes for patients undergoing this type of surgery.

To participate in this trial, patients need to be at least 18 years old and able to understand the study details and provide written consent. They should be scheduled for a DP surgery, whether through minimally invasive techniques or open surgery. However, those who have had previous pancreatic surgeries or are involved in other conflicting trials won't be eligible. Participants can expect to be followed closely during recovery to monitor for any complications and to help improve future surgical practices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older.
• • Ability to understand the nature and consequences of the study.
• • Provision of written informed consent.
• • Scheduled for minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy.
• Exclusion Criteria:
• • Inability to comply with study procedures or follow-up.
• • Multivisceral resection beyond left adrenalectomy.
• • History of previous pancreatic surgeries.
• • Expected lack of compliance with the study protocol.
• • Participation in another trial that may interfere with the intervention or outcomes of this study.