Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control 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 pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.

Study Overview

• Status: Recruiting
• Conditions: Pancreas Neoplasm; Pancreatectomy; Cyst of Pancreas
• Intervention / Treatment: Device: 19 French Blake Drain

Detailed Description

Pancreatic resections are commonly performed across the United States, yet still represent one of the most morbid abdominal operations in the country, with postoperative mortality as high as 7.7%. Distal pancreatectomy (DP) represents one of the most common approaches to pancreatic resection and is typically used for tumors of the pancreatic body or tail. This operation is known to have a high historic morbidity, with reports of overall morbidity between 12-52%. Common complications include intraabdominal abscess and surgical site infection. Postoperative pancreatic fistula (POPF) represents the most common complication following partial pancreatic resection, with rates reported with rates as high as 30% in multiple large retrospective studies. Multiple strategies to prevent postoperative pancreatic leak following distal pancreatectomy have been studied. One of the outstanding questions that remains is regarding the need for routine intraperitoneal drainage following DP, particularly since the advent of reinforced staple technology. This study aims to determine if intraperitoneal drainage is necessary following DP. This study will compare groups using a composite endpoint of complications.

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Robert Simon, MD; Phone Number: 1-866-223-8100; Email: TaussigResearch@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
      • Contact: Robert Simon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.	Device: 19 French Blake Drain; 19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin; Other Names: Intraperitoneal drain
No Intervention: Omitting Standard of Care; No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF	Rates of drainage based off of the Grade B Postoperative pancreatic fistula	90-day post operative time point
Quality of Life Score	Post-operative Quality of Life score using the PROMIS-10 Global Health	At day 14 postoperative
Quality of Life Score	Post-operative Quality of Life score using the PROMIS-10 Physical Function	At day 14 postoperative
Quality of Life Score	Post-operative Quality of Life score using the original Drain Quality of Life scale	At day 14 postoperative
Quality of Life Score	Post-operative Quality of Life score using the PROMIS-10 Global Health	At day 90 postoperative
Quality of Life Score	Post-operative Quality of Life score using the PROMIS-10 Physical Function	At day 90 postoperative
Quality of Life Score	Post-operative Quality of Life score using the original Drain Quality of Life scale	At day 90 postoperative
Hospital Length of Stay	Measurement of the difference in Hospital Length-of-Stay based on intraperitoneal drainage after DP	90-day post operative time point
Cost analysis for overall healthcare costs	Cost analysis for overall healthcare costs associated with both methods of postoperative care	At day 90 postoperative

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Robert Simon, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pancreatic neoplasm
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Cysts; Pancreatic Neoplasms; Pancreatic Cyst
• Other Study ID Numbers: CASE6222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes