Endoscopic Therapy for Esophageal Achalasia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Adults unable to consent, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new and existing endoscopic treatments for individuals with esophageal achalasia and other gastrointestinal issues. The researchers aim to identify the best management strategies using less invasive techniques, such as POEM (Percutaneous Oral Endoscopic Myomectomy), which improves esophageal function. This procedure suits those with frequent heartburn, difficulty swallowing due to achalasia, or complications after weight loss surgery. Participants should have a history of these conditions and be considering surgery. As an unphased trial, this study allows participants to contribute to innovative research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

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 endoscopic intervention is safe for esophageal achalasia?

Studies have shown that procedures like POEM (Peroral Endoscopic Myotomy) are generally safe for treating achalasia, a condition where the esophagus struggles to move food to the stomach. Research indicates that POEM is not only effective but also well-tolerated by most patients. One study found that patients' symptoms improved significantly after the procedure, with over 86% experiencing success one year later. Another study noted that POEM remains safe even for those who had unsuccessful treatments before. Although POEM might lead to more healthcare visits compared to another surgery type (LHM), its safety and effectiveness are well-documented, making it a promising option for those with esophageal muscle issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endoscopic interventions for esophageal achalasia because they offer a less invasive alternative to traditional surgical methods like laparoscopic Heller myotomy. One of the standout features is the Percutaneous Oral Endoscopic Myomectomy (POEM), which uses an endoscope to reach and treat the affected area from within the esophagus, reducing recovery time and potential complications. This method provides a targeted approach that can be performed without large incisions, making it a promising option for patients seeking effective treatment with minimal disruption to their lives.

What evidence suggests that endoscopic intervention is effective for esophageal achalasia?

Studies have shown that endoscopic treatments like per-oral endoscopic myotomy (POEM) effectively treat achalasia, a condition where the esophagus struggles to move food to the stomach. In this trial, participants will receive endoscopic interventions, including POEM. Research indicates that POEM is safe, involves a minimally invasive procedure, and provides excellent long-term results. The procedure uses a flexible tube with a camera and tools to cut the muscles causing the swallowing problem. This method is as effective as traditional surgery but offers a shorter recovery time. Overall, POEM presents a promising option for people with achalasia. ^{6 7 8 9 10}

Who Is on the Research Team?

Mohamed R Ali, MD

Principal Investigator

U.C. Davis Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with various upper and lower GI conditions, including Achalasia, Barrett's Esophagus, GERD, and complications from bariatric surgery. Candidates must qualify for gastrointestinal surgeries of benign or malignant nature. Those unable to consent or not meeting the criteria for endoluminal treatments are excluded.

Inclusion Criteria

I have been diagnosed with achalasia.

I have Barrett's Esophagus.

I have acid reflux.

Exclusion Criteria

I am unable to give consent for medical procedures.

I do not qualify for specific internal treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive endoluminal therapies such as POEM or endoscopic interventions for gastrointestinal conditions

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Intervention

Trial Overview The study is evaluating the outcomes of different endoscopic interventions on patients with a range of GI disorders such as Esophageal Achalasia and complications post-bariatric surgery like fistulas and ulcers.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Patients meeting inclusion criteria for possible surgical therapies for their current condition (IE Achelasia, Enlarged Gastric Pouch and/or Gastrogastric Fistula after primary weight loss surgery, etc) will be educated on the different therapy options including traditional laparoscopic surgery and/or Endoscopic Interventions including POEM (Percutaneous Oral Endoscopic Myomectomy for the treatment of Achelasia) or Endoscoscopic Pouch/GastroJejunostomy repair or closure of the Gastrogastric Fistula as examples.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7165007/

Long-term outcomes of per-oral endoscopic myotomy in ... POEM is a highly effective, safe, and minimally invasive technique to treat Achalasia with excellent long-term efficacy.

2. ales.amegroups.org ales.amegroups.org/article/view/10072/html

Peroral endoscopic myotomy (POEM) for the treatment of ... Conclusions: POEM appears to be a safe and effective endoscopic treatment, alternative to laparoscopic Heller myotomy in the treatment of achalasia. However, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521691824000556

Per oral endoscopic myotomy for achalasia Myotomy length informed by high-resolution esophageal manometry (HREM) results in improved per-oral endoscopic myotomy (POEM) outcomes for type III achalasia ...

4. giejournal.org giejournal.org/article/S0016-5107(17)30261-4/fulltext

218 Outcomes of Peroral Endoscopic Myotomy for ... POEM is a highly safe and effective treatment for esophageal achalasia with excellent long-term outcomes. Time, year, Estimated clinical success rate (95% CI) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6702399/

Peroral endoscopic myotomy (POEM) for achalasia - PMC POEM is a minimally invasive intervention that aims to treat achalasia. It is regarded as the endoscopic equivalent of Heller myotomy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35442413/

Use and Safety of Per-Oral Endoscopic Myotomy for Achalasia ... Results of this cohort study suggest that POEM was associated with higher health care utilization compared with LHM and lower subsequent ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7960968/

Efficacy and Safety of Peroral Endoscopic Myotomy in ... POEM appears to be a safe, effective and feasible treatment for individuals who have undergone previous failed intervention.

8. gut.bmj.com gut.bmj.com/content/74/Suppl_1/A152

P109 Safety and outcomes of per oral endoscopic ... The median Eckardt score pre-POEM was 9 (IQR 7-10), which improved to 3 (IQR 1-4) post-POEM. Clinical success rate was 89.5% at 6 months, and 86.2% at 1 year. 4 ...

9. molinahealthcare.com molinahealthcare.com/~/media/Molina/PublicWebsite/PDF/Common/April2023/Peroral-Endoscopic-Myotomy-for-Esophageal-Achalasia_R.pdf

Molina Clinical Policy Peroral Endoscopic Myotomy (POEM ... POEM appears to be generally safe and may achieve at least equivalent efficacy and harm outcomes to PD and. LHM in the treatment of achalasia.

10. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/peroral-endoscopic-myotomy

Peroral Endoscopic Myotomy (POEM) POEM can be a treatment option for people with muscle disorders in the esophagus, such as achalasia. POEM generally takes up to one hour and is performed ...