Endoscopic Therapy for Esophageal Achalasia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

500 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.

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 data supports the effectiveness of the treatment Endoscopic Intervention for esophageal achalasia?

Endoscopic treatments like pneumatic dilation and peroral endoscopic myotomy have shown promising results in improving symptoms of esophageal achalasia by helping the esophagus empty into the stomach more effectively. These treatments are considered effective in the short to medium term, with pneumatic dilation providing results comparable to surgery. ^{1 2 3 4 5}

Is endoscopic therapy for esophageal achalasia safe?

Endoscopic therapy, like peroral endoscopic myotomy (POEM), is generally safe for treating esophageal achalasia, with major adverse events being uncommon. Some possible issues include minor injuries, bleeding, and pain, but these are often manageable during the procedure. Long-term effects like GERD (acid reflux) can occur, and more research is needed to understand these better. ^{6 7 8 9 10}

How does the endoscopic treatment for esophageal achalasia differ from other treatments?

Endoscopic therapy for esophageal achalasia, specifically per-oral endoscopic myotomy (POEM), is unique because it is a minimally invasive procedure that combines the benefits of endoscopy with the effectiveness of surgical myotomy. It involves creating a tunnel in the esophagus to cut the muscle, which can lead to fewer complications and a lower recurrence rate compared to traditional surgical methods. ^{3 11 12 13 14}

Research Team

Mohamed R Ali, MD

Principal Investigator

U.C. Davis Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Spain pubmed.ncbi.nlm.nih.gov

Short- and medium-term clinical efficacy of three endoscopic therapies for achalasia: a single-blinded prospective study. [2018]

2. Chile pubmed.ncbi.nlm.nih.gov

[Current management of achalasia of the esophagus: critical review and clinical experience]. [2012]

3. Japan pubmed.ncbi.nlm.nih.gov

Surgical management of achalasia. [2020]

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

Controversies in management of achalasia. [2021]

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

Recent trends in endoscopic management of achalasia. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Achalasia: Current therapeutic options. [2023]

7. Mexico pubmed.ncbi.nlm.nih.gov

Major adverse events related to endoscopic or laparoscopic procedures in achalasia. A systematic review and meta-analysis. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Periprocedural safety profile of peroral endoscopic myotomy (POEM)-a retrospective analysis of adverse events according to two different classifications. [2023]

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

Adverse events during and after per-oral endoscopic myotomy: prevention, diagnosis, and management. [2018]

10. Canada pubmed.ncbi.nlm.nih.gov

Endoscope-based treatments for gastroesophageal reflux disease. [2010]

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

POEM for Esophageal Achalasia. [2020]

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

Esophageal Achalasia: Evaluation and Treatment of Recurrent Symptoms. [2022]

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

Laparoscopic Heller Myotomy for Achalasia Technical Aspects. [2018]

14. Netherlands pubmed.ncbi.nlm.nih.gov

[Per-oral endoscopic myotomy in achalasia]. [2018]