Procedure

POEM-F for Achalasia

Baltimore, MD

N/A

Recruiting

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

Must not have

Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc

Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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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

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

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have damage to the lining of my lower esophagus, like ulcers or scars.

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I have serious heart or lung conditions that make anesthesia risky for me.

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My BMI is 30 or higher.

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I have had surgery on my esophagus or stomach before.

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My lower esophagus is abnormally wide or I have a specific swallowing disorder.

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I have had surgery or a procedure for achalasia before.

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I have a large hiatal hernia.

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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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-procedure rate of gastroesophageal reflux

Secondary study objectives

Adverse event of procedure

Clinical success rate of procedure

Distensibility index on EndoFLIP, on follow-up

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met