40 Participants NeededMy employer runs this trial

Arterial Embolization vs Band Ligation for Hemorrhoids

(STRATOS Trial)

SC
Overseen BySaima Chaabane, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jessica K. Stewart, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of two treatments for hemorrhoid bleeding is more effective: hemorrhoidal artery embolization (HAE) or rubber band ligation (RBL). HAE involves using a catheter to block blood flow to the hemorrhoid, while RBL uses small rubber bands to cut off the blood supply. The trial seeks to identify which method better reduces symptoms and improves quality of life. Individuals who have experienced ongoing bleeding from internal hemorrhoids, despite trying other treatments like fiber or creams, may be suitable candidates for the trial. As an unphased trial, this study provides an opportunity to contribute to medical knowledge and potentially find relief from persistent symptoms.

Do I have to stop taking 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 prior data suggests that these methods are safe for treating hemorrhoids?

Previous studies have shown that hemorrhoidal artery embolization (HAE) safely treats hemorrhoids. Most patients experienced only minor side effects, and the procedure was well-received. It succeeded in 93% of patients, though some required repeat procedures. This minimally invasive procedure has a strong safety record.

Rubber band ligation (RBL) is also considered safe for treating hemorrhoids. Research shows it is effective in about 80% to 89% of cases. The procedure is simple and generally well-tolerated, though some patients may experience severe anal pain. Infections are rare but possible. Overall, RBL is widely used and effective for many people.

Both treatments have been used safely for years, with studies supporting their continued use.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for hemorrhoids because they offer innovative methods for reducing discomfort and improving recovery. Hemorrhoidal Artery Embolization is unique because it uses a catheter to insert tiny particles or coils into the blood vessel feeding the hemorrhoid, cutting off blood flow and causing it to shrink. This minimally invasive technique could reduce recovery time compared to traditional surgeries. Rubber Band Ligation, while a more established procedure, is gaining attention for its simplicity and effectiveness, using a band to cut off blood flow, which causes the hemorrhoid to shrink and fall off. These methods aim to provide less invasive, quicker recovery options compared to standard surgical treatments.

What evidence suggests that this trial's treatments could be effective for hemorrhoidal bleeding?

This trial will compare two treatments for hemorrhoids: hemorrhoidal artery embolization (HAE) and rubber band ligation (RBL). Research has shown that HAE effectively reduces hemorrhoid symptoms in about 93% of patients after one month. It is also considered safe and provides long-lasting relief. Meanwhile, RBL improves symptoms in about 89% of patients and is generally well-tolerated. Both treatments work by cutting off blood flow to the hemorrhoids, causing them to shrink. Participants in this trial will receive one of these treatments to evaluate their effectiveness.13456

Who Is on the Research Team?

DJ

Dennis Jensen, MD

Principal Investigator

University of California, Los Angeles

JS

Jessica Stewart, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to under 90 who have ongoing bleeding from internal hemorrhoids (grade II-III) that hasn't improved with basic treatments like diet changes or creams. Participants must be able to give consent and follow the study procedures.

Inclusion Criteria

I still have bleeding hemorrhoids after trying standard home treatments.
I am between 18 and 89 years old.
2. Ability to provide written informed consent.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo either hemorrhoidal artery embolization or rubber band ligation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at 1 week, 1 month, 2 months, 3 months, 6 months, and 12 months

Crossover (optional)

Participants may crossover to the other treatment modality at 6 months if bleeding continues

6-12 months
Follow-up visits similar to initial treatment phase

What Are the Treatments Tested in This Trial?

Interventions

  • Hemorrhoidal Artery Embolization
  • Rubber Band Ligation

Trial Overview

The study compares two non-surgical treatments for bleeding internal hemorrhoids: blocking blood flow using a minimally invasive procedure called artery embolization, versus placing rubber bands around hemorrhoids to make them shrink.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Hemorrhoidal Artery EmbolizationActive Control1 Intervention
Group II: Rubber Band LigationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jessica K. Stewart, MD

Lead Sponsor

Terumo Medical Corporation

Industry Sponsor

Trials
25
Recruited
10,400+

Citations

Outcomes of embolization therapy of superior rectal arteries ...

While 54% of the participants had side effects, they were minor and the procedure still had high favorability among participants [11]. A ...

Outcomes of Hemorrhoidal Artery Embolization from a ...

Clinical success was seen in 93% (124 of 134) of patients at the 1-month follow-up, with 10 patients requiring repeat embolization. There were significant ...

S1366 Long-Term Outcomes of Hemorrhoidal Artery...

Conclusion: HAE is a safe and effective outpatient treatment for internal hemorrhoids, demonstrating durable symptom relief regardless of prior RBL. These ...

Outcomes of Hemorrhoidal Artery Embolization from a ...

HAE was a safe and effective outpatient procedure in the short term for patients with symptom- atic hemorrhoids refractory to conservative management. Funding ...

Outcomes of Hemorrhoidal Artery Embolization from a ...

Clinical success was seen in 93% (124 of 134) of patients at the 1-month follow-up, with 10 patients requiring repeat embolization. There were significant ...

S651 Safety and Efficacy of Hemorrhoidal Artery...

Statistically significant improvements in all outcomes were reported at follow-up (baseline vs 1 month): HRP (4.6 vs 1.7, p < 0.001), HSS (10.2 vs 7.1, p < ...