Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Study Overview

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.

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.

Cyst of Pancreas
Pancreatectomy
Pancreas Neoplasm

DEVICE: 19 French Blake Drain

CASE6222

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-01-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-05
First Submitted that Met QC Criteria 2023-02-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-06
First Posted (ACTUAL) 2023-02-09	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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
NO_INTERVENTION: Omitting Standard of Care No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.

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

NO_INTERVENTION: Omitting Standard of Care

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Robert Simon, MD

Phone Number: 1-866-223-8100

Email: TaussigResearch@ccf.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Robert Simon, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record