Clinical trial · Interventional
Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer
A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatectomy With Lymph Node Dissection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
This study is being performed to investigate if the application of Arista absorbable hemostat (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection for cancer. These fluid collections can become symptomatic in some patients. Arista would be applied to one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after surgery
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocele | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| microsphere-mediated lymphocele prevention | Device | — | UNRESOLVED |
| regional lymph node dissection | Procedure | — | UNRESOLVED |
| robot-assisted laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (microsphere-mediated lymphocele prevention)
- description
- Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis.
- interventionNames
- Procedure: robot-assisted laparoscopic surgery
- Procedure: regional lymph node dissection
- Device: microsphere-mediated lymphocele prevention
Primary outcomes (1)
- measure
- Incidence of postoperative lymphocele formation
- timeFrame
- 3 months after surgery
- description
- The rate of lymphoceles on each side of the pelvis will be compared. Summary statistics will be reported (mean, standard deviation, and range for the continuous variables and frequency and percentages for the categorical variables). In addition, we will determine interrelationships among specific variables using regression and correlation analyses.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Male patients * Patients with prostate cancer who are electing to undergo robotic radical prostatectomy with pelvic lymph node dissection at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center by Dr. Ronney Abaza
References
Publications (0)
Data not yet available