POEM + F for Achalasia - a Pilot Study

Achalasia Clinical Trial

Official title:

Per-oral Endoscopic Myotomy With Fundoplication (POEM+F) for Achalasia - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214443
• Other study ID #: CRE 2021.648
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: Hon Chi Yip, FRCSEd
• Phone: 35052627
• Email: hcyip[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• POEM + 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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Percentage of successful myotomy plus anchorage of gastric fundus to the esophagus by X-TackTM system, without major intra-operative complication.	1 day
Secondary	Clinical success	defined as Eckardt score =3	1 year
Secondary	Incidence of symptomatic reflux	Incidence (percentage) of patients with postoperative symptomatic reflux	1 year
Secondary	Incidence of endoscopic esophagitis	Incidence (Percentage) of endoscopic esophagitis, graded according to Los Angeles classification	1 year
Secondary	Adverse events of procedure	Incidence (Percentage) of adverse events related to POEM + F	30 days