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Drainage After Pancreatectomy for Post-Pancreatectomy Care
Phase 3
Recruiting
Led By Robert Simon, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 90 postoperative
Awards & highlights
Study Summary
This trial will investigate if routine drainage after pancreatectomy can be safely avoided, reducing risk of complications.
Who is the study for?
This trial is for adults who are scheduled to have a distal pancreatectomy, with or without removing the spleen. They must understand and sign consent. It's not for those under 18, pregnant, with previous pancreatic surgery or gastric alterations, failed prior endoscopic interventions due to strictures, certain hernias found before or during surgery, additional organ resections besides pancreas/spleen, if oversewing of the cut pancreas edge occurs, unsafe conditions without a drain present during surgery, or inability to consent.Check my eligibility
What is being tested?
The study tests whether skipping routine intraperitoneal drainage after cutting out part of the pancreas (distal pancreatectomy) using reinforced staple technology is just as good as including it. The focus is on avoiding serious complications like fistulas in the pancreas post-surgery (POPF), needing hospital readmission or infections inside the belly space where organs are.See study design
What are the potential side effects?
Since this trial involves surgical procedures rather than medication administration directly being tested for side effects aren't detailed here. However common risks associated with surgeries may include infection at incision sites pain bleeding and potential complications related to not having a drain if that's what participants receive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 90 postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 90 postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite endpoint comparison
Secondary outcome measures
Cost analysis for overall healthcare costs
Hospital Length of Stay
Quality of Life Score
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Standard of careActive Control1 Intervention
Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.
Group II: Omitting Standard of CareActive Control1 Intervention
No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,676 Total Patients Enrolled
Robert Simon, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a cystogastrostomy procedure before.I am unable to understand and give consent for treatment.My previous attempts to treat my esophageal condition with endoscopy or ultrasound were unsuccessful.I am having surgery that involves organs other than the pancreas, spleen, or gallbladder.My pancreas surgery involved stitching the cut edge.I had surgery complications that required a drain to be placed in my abdomen.I am under 18 years old.I have had surgery on my pancreas before.I have a Type 3 or Type 4 Paraesophageal Hernia.I have had surgery on my stomach in the past.I am scheduled for surgery to remove part of my pancreas.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care
- Group 2: Omitting Standard of Care
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation still actively seeking participants?
"Affirmative. Global medical trial registries show that the study is actively looking for participants, with an original posting date of July 1st 2023 and a most recent update on March 16th 2023. This research venture requires 234 volunteers from one single location."
Answered by AI
How many participants have enrolled in this medical study thus far?
"Indeed, the information available on clinicaltrials.gov suggests that this health trial is actively searching for participants. It was initially posted in July 1st 2023 and updated as recently as March 16th 2023. The research team aims to acquire 234 patients from a single site."
Answered by AI
What risks do patients face when receiving the accepted level of medical care?
"Our organisation has assigned Standard of care a ranking of 3 on the safety scale as there are existing records which affirm its efficacy, alongside several data points attesting to its security."
Answered by AI
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