Clinical trial NCT05214443: POEM + F for Achalasia - a Pilot Study
Official title: Per-oral Endoscopic Myotomy With Fundoplication (POEM+F) for Achalasia - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Achalasia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Per-oral endoscopic Myotomy with fundoplication (POEM + F)
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: * Inclusion criteria

  1. Patients with achalasia diagnosed with high resolution manometry, scheduled for elective per-oral endoscopic myotomy
  2. Age \>18
* Exclusion criteria

  1. Prior treatment for achalasia, including surgical myotomy, dilatation or POEM.
  2. Prior upper abdominal surgery
  3. Other cases deemed by the examining physician as unsuitable for safe treatment
  4. Patients who refused to participate

Primary outcomes:
measure: Technical success
timeFrame: 1 day
Secondary outcomes:
measure: Clinical success
timeFrame: 1 year
measure: Incidence of symptomatic reflux
timeFrame: 1 year
measure: Incidence of endoscopic esophagitis
timeFrame: 1 year
measure: Adverse events of procedure
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Hon Chi Yip, FRCSEd
role: PRINCIPAL_INVESTIGATOR
References: