Catheter Sclerotherapy for Abdominal Abscess

(ABCS Trial)

Overseen By Evan Husdon, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Lactation, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 48

Duration: 1 week

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

Provision of signed and dated informed consent form

I am willing and able to follow the study rules and attend all appointments.

I am over 18 years old.

Exclusion Criteria

Pregnancy or lactation

Known allergic reactions to povidone iodine or ethanol

My blood pressure and heart rate are stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Catheter-based drainage and sclerotherapy using povidone iodine or ethanol for non-fistulous intraabdominal abscesses

1 week

In-hospital stay for at least 48 hours

Follow-up

Participants are monitored for tolerability and need for catheter reinsertion

1 week

Phone check-in

What Are the Treatments Tested in This Trial?

Interventions

• Catheter Sclerotherapy

Trial Overview

The ABCS trial is testing whether chemical sclerosants like ethanol and povidone iodine can reduce the time needed for catheter drainage in abdominal abscess cases. It's a phase I/II study with two groups of patients, each receiving different treatments.

How Is the Trial Designed?

Group I: Iodine Arm Active Control 1 Intervention

Catheter-based drainage and povidone iodine sclerotherapy of non-fistulous intraabdominal abscesses.

Group II: Ethanol Arm Active Control 1 Intervention

Catheter-based drainage and ethanol sclerotherapy of non-fistulous intraabdominal abscesses.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Argon Medical Devices

Industry Sponsor

Trials

5

Recruited

1,600+

Published Research Related to This Trial

The review highlights an increasing trend in adverse events associated with clinical catheters, emphasizing the need for better understanding and management of these risks.

By analyzing numerous clinical studies and literature, the review aims to identify common adverse events and their causes, providing evidence to help reduce the incidence of these events and prevent serious complications during catheter use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of Adverse Events in Clinical Use of Catheter]. Yin, J., Wang, Y., Zhang, L., et al.[2018]

Citations

1.

ctv.veeva.com

ctv.veeva.com/study/abdominal-abscess-catheter-sclerotherapy-abcs

Abdominal aBscess Catheter Sclerotherapy (ABCS)

The primary outcomes of interest will be tolerability and need for catheter reinsertion by one week post intervention.

2.

withpower.com

withpower.com/trial/phase-2-abscess-6-2025-ef59d

Catheter Sclerotherapy for Abdominal Abscess (ABCS Trial)

Catheter drainage for abdominal abscesses has a low complication rate of 3.8%, and studies on similar procedures for lung abscesses reported no complications, ...

3.

journals.lww.com

journals.lww.com/eusjournal/fulltext/2020/09010/long_term_safety_and_efficacy_of_ethanol_retention.5.aspx

Long-term safety and efficacy of ethanol retention therapy...

Ethanol retention therapy (ERT) under EUS guidance or a percutaneous approach is a safe treatment for large symptomatic hepatic cysts.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1051044392720442

Abdominal Abscesses Associated with Enteric Fistulas

The duration of drainage ranged from 4 days to 3 months. Fistulas healed in 21 of 24 patients (88%) without surgical intervention. Complications were few and ...

5.

mdpi.com

mdpi.com/2077-0383/13/5/1472

Complete and Incomplete Alcohol Sclerotherapy for ...

The purpose of this study was to compare the efficacy of incomplete alcohol sclerotherapy with complete treatment for hepatic cysts.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1028455917301432

Evaluation of sclerotherapy for the treatment of infected ...

Sclerotherapy was clinically successful in 13 lymphoceles in both group A-S (76.5%) and group B-S (92.9%) without statistical significance. Compared to the pre- ...

7.

dirjournal.org

dirjournal.org/articles/a-comparison-of-lymphatic-embolization-and-sclerotherapy-in-the-management-of-iatrogenic-abdominopelvic-lymphoceles-following-oncological-surgery/dir.2023.232135

A comparison of lymphatic embolization and sclerotherapy ...

This study found that LE had a higher clinical success rate after the first procedure and a shorter time to drain removal compared with sclerotherapy. There was ...