Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

NCT ID: NCT05720338

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2027-07-31

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.

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.

Conditions

Cyst of Pancreas; Pancreatectomy; Pancreas Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care

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

Group Type: ACTIVE_COMPARATOR

19 French Blake Drain

Intervention Type: DEVICE

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

Omitting Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

19 French Blake Drain

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

Intervention Type: DEVICE

Other Intervention Names

Intraperitoneal drain

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert Simon, MD

Role: CONTACT

TaussigResearch@ccf.org

1-866-223-8100

Facility Contacts

Robert Simon, MD

Role: primary

Other Identifiers

CASE6222

Identifier Type: -

Identifier Source: org_study_id