NCT05720338

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P25-P50 for phase_3

Timeline
15mo left

Started Apr 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Apr 2023Jul 2027

First Submitted

Initial submission to the registry

January 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

January 27, 2023

Last Update Submit

February 17, 2026

Conditions

Cyst of PancreasPancreatectomyPancreas Neoplasm

Keywords

Pancreatic neoplasm

Outcome Measures

Primary Outcomes (4)

  • Composite endpoint comparison

    Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF

    Within 90 days of surgery

  • Composite endpoint comparison

    Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF

    Within 90 days of surgery

  • Composite endpoint comparison

    Comparison between groups using a composite endpoint of complications that includes Readmission

    Within 90 days of surgery

  • Composite endpoint comparison

    Comparison between groups using a composite endpoint of complications that includes presence of Organ Space Surgical Site Infection

    Within 90 days of surgery

Secondary Outcomes (9)

  • Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF

    90-day post operative time point

  • Quality of Life Score

    At day 14 postoperative

  • Quality of Life Score

    At day 14 postoperative

  • Quality of Life Score

    At day 14 postoperative

  • Quality of Life Score

    At day 90 postoperative

  • +4 more secondary outcomes

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Device: 19 French Blake Drain

Omitting Standard of Care

NO INTERVENTION

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

Interventions

19 French Blake DrainDEVICE

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

Also known as: Intraperitoneal drain
Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic CystPancreatic Neoplasms

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsEndocrine System Diseases

Study Officials

  • Robert Simon, MD

    Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Simon, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 9, 2023

Study Start

April 13, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)