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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care. |
|
| Omitting Standard of Care | No Intervention | No intraperitoneal drain will be placed in the participants, which omits the routine standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 19 French Blake Drain | Device | 19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Simon, MD | Contact | 1-866-223-8100 | TaussigResearch@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Simon, MD | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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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 |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |