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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Catheter Sclerotherapy for Abdominal Abscess?

Catheter-directed sclerotherapy has been used effectively for treating chronic venous leg ulcers and involves delivering a sclerosing agent (a substance that causes blood vessels to shrink) directly to the target area. This suggests that a similar approach could potentially be effective for treating abdominal abscesses by targeting and reducing the abscess. ^{1 2 3 4 5}

Is catheter sclerotherapy for abdominal abscess safe?

Catheter drainage for abdominal abscesses has a low complication rate of 3.8%, and studies on similar procedures for lung abscesses reported no complications, suggesting it is generally safe. ^{6 7 8 9 10}

How is Catheter Sclerotherapy different from other treatments for abdominal abscesses?

Catheter Sclerotherapy is unique because it involves using a catheter to directly deliver a sclerosing agent (a substance that causes tissue to harden) into the abscess, which can help shrink it. This method is minimally invasive compared to traditional surgery and may offer a quicker recovery with fewer complications. ^{6 11 12 13 14}

What is the purpose of this trial?

This is a single center, two arm phase I/II clinical trial exploring the use of chemical sclerosants (ethanol and povidone iodine) in decreasing the time needed for catheter drainage for patients with non-fistulous intraabdominal abscesses. The target study sample size is 60 patients, 30 in each arm and abscess size is to be a minimum of 3cm in all 3 dimensions. The primary outcomes of interest will be tolerability and need for catheter reinsertion by one week post intervention.

Research Team

Junaid Raja, MD, MSPH, FACP

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Splenic abscess--a possible complication of endoscopic variceal sclerotherapy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Pyogenic meningitis and cerebral abscesses after endoscopic injection sclerotherapy. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

Outcome of injection sclerotherapy using absolute alcohol in patients with cirrhosis, non-cirrhotic portal fibrosis, and extrahepatic portal venous obstruction. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Catheter-directed foam sclerotherapy for chronic venous leg ulcers. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Catheter-directed sclerotherapy. [2016]

6. Canada pubmed.ncbi.nlm.nih.gov

Percutaneous catheter drainage of abdominal abscesses. [2007]

7. Germany pubmed.ncbi.nlm.nih.gov

[Ablation of supraventricular tachycardias : Complications and emergencies]. [2022]

8. India pubmed.ncbi.nlm.nih.gov

MANAGEMENT OF LUNG ABSCESS WITH PERCUTANEOUS CATHETER DRAINAGE. [2020]

9. Ireland pubmed.ncbi.nlm.nih.gov

Percutaneous drainage of abdominal abcess. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[Analysis of Adverse Events in Clinical Use of Catheter]. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[Minimally invasive treatment of abscesses by CT-controlled drainage with a basket catheter system]. [2016]

12. Germany pubmed.ncbi.nlm.nih.gov

[Results of sonographically guided percutaneous catheter drainage of intra-abdominal abscesses in surgery]. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

[Percutaneous drainage of abdominal abscesses. II. Value in comparison with septic surgery]. [2006]

14. England pubmed.ncbi.nlm.nih.gov

Percutaneous drainage of intra-abdominal abscesses using large lumen tubes under computed tomographic control. [2016]