Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Enrolling; Phase 3

Conditions: Cyst of Pancreas; Pancreas Neoplasm; Pancreatectomy

Treatments: Device: 19 French Blake Drain

Study type: Interventional

Funder types: Other

Identifiers

NCT05720338

CASE6222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

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

Treatment:

Device: 19 French Blake Drain

Omitting Standard of Care

No Intervention group

Description:

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