Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Recruiting
Phase 3
Interventional Study
Cyst of Pancreas
Pancreatectomy
Pancreas Neoplasm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 234 (estimated)
- Sponsor
- Case Comprehensive Cancer Center · Other
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About This Trial
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
* Age ≥18 years
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients \< 18 years o…
Contacts