Cyst of Pancreas, Pancreas Neoplasm, Pancreatectomy
Conditions
Keywords
Pancreatic neoplasm
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.
Interventions
DEVICE19 French Blake Drain
19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint comparison | Within 90 days of surgery | Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF | 90-day post operative time point | Rates of drainage based off of the Grade B Postoperative pancreatic fistula |
| Quality of Life Score | At day 14 postoperative | Post-operative Quality of Life score using the PROMIS-10 Global Health |
| Hospital Length of Stay | 90-day post operative time point | Measurement of the difference in Hospital Length-of-Stay based on intraperitoneal drainage after DP |
| Cost analysis for overall healthcare costs | At day 90 postoperative | Cost analysis for overall healthcare costs associated with both methods of postoperative care |
Countries
United States
Contacts
CONTACTRobert Simon, MD
PRINCIPAL_INVESTIGATORRobert Simon, MD
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Outcome results
None listed