Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler

NCT06764134 | Recruiting

• 1 other identifier: S-473/2024
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, observational study evaluates the rate of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) using the AEON™ Endostapler. The study involves 110 patients undergoing DP and assesses primary outcomes based on the International Study Group of Pancreatic Fistula (ISGPF) classification, alongside secondary perioperative parameters. The findings aim to optimize surgical techniques, reduce complications, and improve healthcare outcomes.

Conditions

Pancreas; Fistula; Pancreas Cancer; Pancreatic Disease; Surgery-Complications; Surgery

Outcome Measures

Primary Outcomes (1)

• Rate of Clinically Relevant Postoperative Pancreatic Fistula (POPF)

  The rate of clinically relevant POPF will be assessed based on the International Study Group of Pancreatic Fistula (ISGPF) definition, which includes drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content exceeding three times the upper limit of normal serum amylase activity, associated with a clinically relevant condition.

  Up to 90 days post-surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years or older scheduled to undergo minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy. These patients will be recruited from the University of Heidelberg and screened for eligibility based on inclusion and exclusion criteria. Participants must provide informed consent and demonstrate the ability to comply with study procedures and follow-up assessments.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Pancreatic Fistula; Pancreatic Neoplasms; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: November 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

DE (1)