← Back to Search

Procedure

POEM-F for Achalasia

N/A

Waitlist Available

Led By Hon Chi Yip, FRCSEd

Research Sponsored by Chinese University of Hong Kong

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial aims to compare the efficacy of POEM-F vs POEM in reducing post-procedure GERD in achalasia patients, with experts from multiple countries participating. It could potentially replace conventional POEM as the preferred treatment for achalasia.

Who is the study for?

Adults aged 18-65 with symptomatic achalasia types I or II, who are either treatment-naive or have had unsuccessful balloon dilation. Excluded are those with prior esophageal surgery, significant comorbidities preventing anesthesia, obesity (BMI ≥ 30), pregnancy, breastfeeding, large hiatal hernias, or certain blood conditions.Check my eligibility

What is being tested?

The trial compares two procedures for achalasia: conventional POEM and a new method called POEM-F which includes an endoscopic fundoplication to potentially reduce gastroesophageal reflux disease (GERD) after the procedure. It's an international study measuring GERD incidence one year post-treatment.See study design

What are the potential side effects?

Possible side effects include complications from general anesthesia and risks associated with endoscopic procedures such as infection or bleeding. Specific to this trial is the potential for developing GERD following the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old and have achalasia type I or II.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-procedure rate of gastroesophageal reflux

Secondary outcome measures

Adverse event of procedure

Clinical success rate of procedure

Distensibility index on EndoFLIP, on follow-up

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Per-oral endoscopic myotomy with fundoplicationExperimental Treatment1 Intervention

The detail of the procedure has been reported in the literature. After completion of myotomy as per conventional anterior POEM, a serosal incision would be made at the level of the GE junction below the diaphragmatic crus. The peritoneal cavity would then be entered and the anterior gastric wall could be identified. A detachable endoloop would be introduced alongside the endoscope with the guidance of endoscopic clip. Three to four clips would be applied to the anterior gastric fundus while additional 3-4 clips would be applied to the edge of the submucosal tunnel, all anchoring to the endoloop. Upon tightening of the endoloop the anterior fundus would be approximated to the esophagogastric junction and thus completing the partial anterior fundoplication. Abdominal paracentesis to treat capnoperitoneum would be performed as required based on patient's clinical condition.

Group II: Conventional POEMActive Control1 Intervention

Conventional per-oral endoscopic myotomy An anterior POEM would be performed per usual manner described in the literature. The procedure would be performed under general anaesthesia by expert endoscopists with at least 50 case experience of conventional POEM and 5 cases experience of POEM-F. The requirement of POEM experience is based on a recent multicenter study of learning curve by Fujiyoshi Y, et al. The procedure would follow the current recommendations from expert panel in reducing GER, including avoidance of excessive gastric myotomy and preservation of the sling fibers are the gastric cardia. The length of the esophageal and gastric myotomy is standardized at 5cm and 2cm respectively

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Chinese University of Hong KongLead Sponsor

1,264 Previous Clinical Trials

1,213,066 Total Patients Enrolled

3 Trials studying Achalasia

80 Patients Enrolled for Achalasia

Deenanath Mangeshkar Hospital and Research CentreOTHER

Johns Hopkins UniversityOTHER

2,259 Previous Clinical Trials

14,820,572 Total Patients Enrolled

3 Trials studying Achalasia

150 Patients Enrolled for Achalasia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study have an age restriction, and if so, what is it?

"According to the study's entry requirements, the minimum age of participants must be 18 and no older than 65."

Answered by AI

Are enrollees being accepted for this clinical trial at present?

"Unfortunately, the details listed on clinicaltrials.gov indicate that this medical trial has stopped patient recruitment. Initially posted in November of 2023 and recently updated in September of 2023, there are nonetheless twenty other studies currently enrolling volunteers right now."

Answered by AI

Has this research endeavor been implemented in numerous facilities across the US?

"At the present moment, this clinical trial has 7 active sites. These locations include Guangzhou, Hong Kong and Chandigarh in addition to 4 other spots. To minimize journey commitments, participants should aim to pick the closest site for enrollment."

Answered by AI

To whom does this study render eligibility?

"This clinical trial is recruiting 81 adults aged 18-65 suffering from achalasia. Essential requirements to take part include having type I or II of the condition and either not receiving any prior treatment, or have unsuccessfully undertaken through-the-scope balloon dilation, Savary dilations, or pneumatic dilation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

POEM-F for Achalasia International Study

Hon Chi Yip 2023. "POEM-F for Achalasia International Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042127.

All > Achalasia