Catheter Sclerotherapy for Abdominal Abscess
(ABCS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two chemicals, ethanol and povidone iodine, to determine if they can speed up the drainage of abdominal abscesses (pockets of pus inside the belly) through catheter sclerotherapy. Researchers aim to find out if these treatments can reduce the need to reinsert the catheter within a week. The trial includes two groups: one receiving povidone iodine and the other receiving ethanol. Individuals with an abdominal abscess at least 3 cm in size, as seen on a scan, and without a fistula (an abnormal connection) to the bowel or skin, might be suitable candidates. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that using a catheter to drain abdominal abscesses results in a low complication rate of 3.8%. Other research on similar procedures, such as those for lung abscesses, reported no complications. Povidone iodine sclerotherapy, which involves injecting a solution into a problem area, has been used in other conditions without long-term issues.
Previous treatments for large liver cysts using ethanol retention therapy have been safe. This trial is in the early stages, so researchers are still learning how well people can handle these treatments. So far, data from similar uses look promising, but more information will become available as the trial continues.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because catheter sclerotherapy for abdominal abscesses offers a novel approach compared to traditional surgical drainage. Unlike conventional methods that primarily rely on surgery, this technique uses a catheter to directly drain the abscess and administer a sclerosing agent, either povidone iodine or ethanol, to shrink the abscess cavity. This minimally invasive method could potentially reduce recovery time and limit complications associated with more invasive procedures. Additionally, the use of povidone iodine and ethanol as sclerosing agents might offer different benefits, such as antiseptic properties for iodine and dehydrating effects for ethanol, which could further enhance treatment effectiveness.
What evidence suggests that this trial's treatments could be effective for abdominal abscess?
This trial will compare two treatment arms: one using povidone iodine sclerotherapy and the other using ethanol sclerotherapy for catheter-based drainage of non-fistulous intraabdominal abscesses. Studies have shown that povidone iodine sclerotherapy achieves a 93% success rate in treating stubborn abscesses. It is considered safe and involves only a minor procedure. Research indicates that ethanol sclerotherapy is also a safe and effective treatment for large cysts, with successful results reported. Both treatments reduce the need to reinsert a catheter, minimizing the time spent with one in place. These findings suggest that both povidone iodine and ethanol sclerotherapy could effectively shorten the time needed to drain abdominal abscesses.12367
Who Is on the Research Team?
Junaid Raja, MD, MSPH, FACP
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for patients with non-fistulous intraabdominal abscesses that are at least 3cm in size. Participants must be suitable for catheter drainage and not have any conditions that would exclude them from the study, such as fistulas or allergies to the sclerosants used.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Catheter-based drainage and sclerotherapy using povidone iodine or ethanol for non-fistulous intraabdominal abscesses
Follow-up
Participants are monitored for tolerability and need for catheter reinsertion
What Are the Treatments Tested in This Trial?
Interventions
- Catheter Sclerotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Argon Medical Devices
Industry Sponsor