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RecruitingNCT05214443Updated Sep 7, 2023

POEM + F for Achalasia - a Pilot Study

An interventional study of POEM + F in Achalasia, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a pilot study to investigate the feasibility of performing per-oral endoscopic Myotomy (POEM) with endoscopic fundoplication for patient with achalasia. Post-POEM reflux is a well documented adverse event after POEM for achalasia. Case series have been published by addition of endoscopic fundoplication procedure during POEM. In the current study, 10 patients would be recruited for investigating the novel POEM procedure with fundoplication by using a new X-tack anchoring device.

Read the detailed description

Since the first published case series, per-oral endoscopic myotomy (POEM) has emerged as one of the standard treatment options for achalasia. The procedure offers a scarless endoscopic alternative to conventional surgical myotomy. In a recent randomized controlled trial, POEM was found to achieve similar treatment success rate when compared with surgical myotomy. POEM was also found to have reduced serious adverse events. When compared with endoscopic pneumatic dilatation, POEM was demonstrated to have a significantly higher clinical success rate.

One of the major limitations of POEM was the higher incidence of post-procedural acid reflux. During surgical myotomy, a partial fundoplication would routinely be performed to reinforce the gastro-esophageal junction, and such procedure has been proven to reduce post-operative reflux. Multiple studies have confirmed the higher incidence of endoscopic reflux esophagitis and proton pump requirements after POEM than surgical myotomy, including the aforementioned randomized trial.

Modification and standardization of the POEM techniques were proposed to reduce the incidence of reflux esophagitis. Limitation of gastric myotomy length to below 2cm was found to be a useful maneuver. Identification of the two penetrating vessels at cardia may help to correctly measure the length of gastric myotomy, together with the use of double scope technique.

In an attempt to reduce the risk of post-POEM reflux, researchers have also pioneered procedures to mimic surgical fundoplication. The POEM + fundoplication (POEM+F) procedure, was first reported in 2019. It involved anterior myotomy, followed by an anterior partial fundoplication using endoscopic clips and detachable loop. The same group subsequently modified the technique by using a novel endoscopic needle holder device. A recent single-center study reporting results of 25 POEM+F procedures in India also confirmed its reproducibility and safety, as well as a reasonably low incidence of reflux.

A recently developed endoscopic tacking device, X-TackTM (Apollo EndoSurgery, Inc, United States), allows approximation of tissue with the use of a helix tacking system connected to a suture. It could be applied for closure of defect after endoscopic resection. The novel device may also potentially be used for the endoscopic fundoplication by approximating the anterior fundus to the edge of esophageal myotomy during POEM+F. The simple design of the device could make the fundoplication easier and less time consuming. The investigators designed this pilot study to confirm the feasibility of using X-TackTM for POEM+F in patients with achalasia.

02

Conditions studied

  • Achalasia

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03

In context

Esophageal Achalasia

140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 93 interventional studies indexed under Esophageal Achalasia.

Browse Esophageal Achalasia studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with achalasia diagnosed with high resolution manometry, scheduled for elective per-oral endoscopic myotomy

    1. Age >18

Exclusion criteria

  1. Prior treatment for achalasia, including surgical myotomy, dilatation or POEM.

    1. Prior upper abdominal surgery
    2. Other cases deemed by the examining physician as unsuitable for safe treatment
    3. Patients who refused to participate
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    POEM + F arm

    This arm will receive the POEM + F procedure

    Procedure: POEM + F

Interventions

  • ProcedurePOEM + F

    POEM would first be performed as per usual technique. Upon completion of the myotomy, a 2cm incision would be created over the adventitial layer at the level of gastro-esophageal junction (GEJ), allowing scope entry into the peritoneal cavity. The anterior part of the gastric fundus would be located, grasped with endoscopic forceps and pulled towards the esophageal myotomy site. The intended anterior fundus would then be anchored to the edge of the muscle at the GEJ, with the use of X-TackTM system. After confirming adequate hemostasis and secure anchorage of fundus to the esophagus, the mucosal entry site for the submucosal tunnel would be closed with endoscopic clips as per usual POEM technique.

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What researchers measure

Primary outcomes

  1. Technical success

    Percentage of successful myotomy plus anchorage of gastric fundus to the esophagus by X-TackTM system, without major intra-operative complication.

    Time frame: 1 day

Secondary outcomes

  1. Clinical success

    defined as Eckardt score ≤3

    Time frame: 1 year

  2. Incidence of symptomatic reflux

    Incidence (percentage) of patients with postoperative symptomatic reflux

    Time frame: 1 year

  3. Incidence of endoscopic esophagitis

    Incidence (Percentage) of endoscopic esophagitis, graded according to Los Angeles classification

    Time frame: 1 year

  4. Adverse events of procedure

    Incidence (Percentage) of adverse events related to POEM + F

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • The Chinese University of Hong Kong
    Hong Kong, Hong Kong
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05214443
Lead sponsor
Chinese University of Hong Kong
Responsible party
Hon Chi Yip (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Jan 28, 2022
Start date
Mar 24, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Sep 7, 2023

Study contacts

Hon Chi Yip, FRCSEd
Contact
hcyip@surgery.cuhk.edu.hk
35052627
Hon Chi Yip, FRCSEd
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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