Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Trial Title: Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

NCT ID: NCT05720338

Condition: Cyst of Pancreas
Pancreatectomy
Pancreas Neoplasm

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
Pancreatic neoplasm

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: 19 French Blake Drain
Description: 19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin
Arm group label: Standard of care

Other name: Intraperitoneal drain

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Address:
City: Cleveland
Zip: 44195
Country: United States

Status: Recruiting

Contact:
Last name: Robert Simon, MD

Start date: April 13, 2023

Completion date: July 31, 2027

Lead sponsor:
Agency: Case Comprehensive Cancer Center
Agency class: Other

Source: Case Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05720338