POEM + F for Achalasia - a Pilot Study

NCT05214443 | Unknown

• 1 other identifier: CRE 2021.648
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia

Outcome Measures

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.

  1 day

Secondary Outcomes (4)

• Clinical success

  1 year

• Incidence of symptomatic reflux

  1 year

• Incidence of endoscopic esophagitis

  1 year

• Adverse events of procedure

  30 days

Study Arms (1)

POEM + F arm

EXPERIMENTAL

This arm will receive the POEM + F procedure

Procedure: POEM + F

Interventions

POEM + F PROCEDURE

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.

POEM + F arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with achalasia diagnosed with high resolution manometry, scheduled for elective per-oral endoscopic myotomy
• Age \>18

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

nephronectin

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hon Chi Yip, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Chi Yip, FRCSEd

CONTACT

35052627; hcyip@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Per-oral endoscopic Myotomy with fundoplication (POEM + F)

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: January 28, 2022
• Study Start: March 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)