Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Phase

Condition

Digestive System Neoplasms

Treatment

19 French Blake Drain

Clinical Study ID

NCT05720338

CASE6222

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects must be undergoing a scheduled distal pancreatectomy (with or withoutconcurrent splenectomy)
Age ≥18 years
Subjects must have the ability to understand and the willingness to sign a writteninformed consent document.

Exclusion

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 sleevegastrectomy
Patients with prior cystogastrostomy procedure
Patients who have failed prior endoscopic intervention or ultrasound due toesophageal or other gastrointestinal stricture
Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operativeimaging or intra-operatively
Patients undergoing concurrent resection of organs other than the pancreas or spleenor gallbladder
Patients who undergo oversewing of the pancreatic transection margin
Patients with unexpected intraoperative bleeding or adhesive disease which deem itunsafe to proceed without an intraabdominal drain
Patients who are unable to provide informed consent

Study Design

19 French Blake Drain

April 13, 2023

July 31, 2027

Study 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.

Connect with a study center

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44195
United States
Active - Recruiting

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