Clinical trial NCT05720338: Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Official title: Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cyst of Pancreas
Pancreatectomy
Pancreas Neoplasm
Keywords: Pancreatic neoplasm
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Composite endpoint comparison
timeFrame: Within 90 days of surgery
measure: Composite endpoint comparison
timeFrame: Within 90 days of surgery
measure: Composite endpoint comparison
timeFrame: Within 90 days of surgery
measure: Composite endpoint comparison
timeFrame: Within 90 days of surgery
Secondary outcomes:
measure: Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF
timeFrame: 90-day post operative time point
measure: Quality of Life Score
timeFrame: At day 14 postoperative
measure: Quality of Life Score
timeFrame: At day 14 postoperative
measure: Quality of Life Score
timeFrame: At day 14 postoperative
measure: Quality of Life Score
timeFrame: At day 90 postoperative
measure: Quality of Life Score
timeFrame: At day 90 postoperative
measure: Quality of Life Score
timeFrame: At day 90 postoperative
measure: Hospital Length of Stay
timeFrame: 90-day post operative time point
measure: Cost analysis for overall healthcare costs
timeFrame: At day 90 postoperative
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Robert Simon, MD
role: PRINCIPAL_INVESTIGATOR
References: