Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Pancreas Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720338
• Other study ID #: CASE6222
• Status: Recruiting
• Phase: Phase 3
• Start date: April 13, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: January 2024
• Source: Case Comprehensive Cancer Center
• Contact: Robert Simon, MD
• Phone: 1-866-223-8100
• Email: TaussigResearch[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: July 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Neoplasm
• Pancreatectomy
• Pancreatic Neoplasms

Intervention

Device:
• 19 French Blake Drain
19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint comparison	Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF	Within 90 days of surgery
Primary	Composite endpoint comparison	Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF	Within 90 days of surgery
Primary	Composite endpoint comparison	Comparison between groups using a composite endpoint of complications that includes Readmission	Within 90 days of surgery
Primary	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	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
Secondary	Quality of Life Score	Post-operative Quality of Life score using the PROMIS-10 Global Health	At day 14 postoperative
Secondary	Quality of Life Score	Post-operative Quality of Life score using the PROMIS-10 Physical Function	At day 14 postoperative
Secondary	Quality of Life Score	Post-operative Quality of Life score using the original Drain Quality of Life scale	At day 14 postoperative
Secondary	Quality of Life Score	Post-operative Quality of Life score using the PROMIS-10 Global Health	At day 90 postoperative
Secondary	Quality of Life Score	Post-operative Quality of Life score using the PROMIS-10 Physical Function	At day 90 postoperative
Secondary	Quality of Life Score	Post-operative Quality of Life score using the original Drain Quality of Life scale	At day 90 postoperative
Secondary	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
Secondary	Cost analysis for overall healthcare costs	Cost analysis for overall healthcare costs associated with both methods of postoperative care	At day 90 postoperative