Recruiting
Phase 3

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT05720338

Conditions

Cyst of Pancreas

Pancreatectomy

Pancreas Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

19 French Blake Drain

Study Details

Brief summary:

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 pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.

Conditions

Cyst of Pancreas

Pancreatectomy

Pancreas Neoplasm

Study ID

NCT05720338

Start date

Apr 13, 2023

Status verified date

Feb, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 old
  • Patients who are pregnant
  • Patients with a history of previous pancreatic surgery
  • Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
  • Patients with prior cystogastrostomy procedure
  • Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture
  • Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
  • Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
  • Patients who undergo oversewing of the pancreatic transection margin
  • Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
  • Patients who are unable to provide informed consent

Study Design

Enrollment

234 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Standard of care

Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.

no intervention: Omitting Standard of Care

No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.

Interventions

19 French Blake Drain

19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin

Primary outcome measure

  • Composite endpoint comparison [ Time Frame: Within 90 days of surgery ]
  • Composite endpoint comparison [ Time Frame: Within 90 days of surgery ]
  • Composite endpoint comparison [ Time Frame: Within 90 days of surgery ]
  • Composite endpoint comparison [ Time Frame: Within 90 days of surgery ]

Central Contacts and Locations

Central contacts

Robert Simon, MD

1-866-223-8100TaussigResearch@ccf.org

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Pancreatic neoplasm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-02-19.