Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial

Conditions
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Cyst of Pancreas, Pancreatectomy, Pancreas Neoplasm

Intervention / Treatment
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* Device: 19 French Blake Drain


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care. | Device: 19 French Blake Drain<br>* 19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin<br>* Other names: Intraperitoneal drain;|
| No Intervention: Omitting Standard of Care<br>No intraperitoneal drain will be placed in the participants, which omits the routine standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint comparison | Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF | Within 90 days of surgery | 
| Composite endpoint comparison | Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF | Within 90 days of surgery | 
| Composite endpoint comparison | Comparison between groups using a composite endpoint of complications that includes Readmission | Within 90 days of surgery | 
| Composite endpoint comparison | Comparison between groups using a composite endpoint of complications that includes presence of Organ Space Surgical Site Infection | Within 90 days of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF | Rates of drainage based off of the Grade B Postoperative pancreatic fistula | 90-day post operative time point | 
| Quality of Life Score | Post-operative Quality of Life score using the PROMIS-10 Global Health | At day 14 postoperative | 
| Quality of Life Score | Post-operative Quality of Life score using the PROMIS-10 Physical Function | At day 14 postoperative | 
| Quality of Life Score | Post-operative Quality of Life score using the original Drain Quality of Life scale | At day 14 postoperative | 
| Quality of Life Score | Post-operative Quality of Life score using the PROMIS-10 Global Health | At day 90 postoperative | 
| Quality of Life Score | Post-operative Quality of Life score using the PROMIS-10 Physical Function | At day 90 postoperative | 
| Quality of Life Score | Post-operative Quality of Life score using the original Drain Quality of Life scale | At day 90 postoperative | 
| Hospital Length of Stay | Measurement of the difference in Hospital Length-of-Stay based on intraperitoneal drainage after DP | 90-day post operative time point | 
| Cost analysis for overall healthcare costs | Cost analysis for overall healthcare costs associated with both methods of postoperative care | At day 90 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic neoplasm