BridgeMD
New treatment option for Cyst of Pancreas
Official title Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
ClinicalTrials.gov ID: NCT05720338
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
- Age ≥18 years
- people must have the ability to understand and the willingness to sign a written informed consent document.
You likely can't join if
- 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
See the full eligibility criteria
- people must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
- Age ≥18 years
- people must have the ability to understand and the willingness to sign a written informed consent document.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.