POEM-F for Achalasia International Study

NCT06042127 | Recruiting DMC

• 1 other identifier: 2023 145-T
• Study Type: interventional
• Target: 81
• Locations: 4 countries
• Sites: 7

Brief Summary

Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy. The main concern with POEM is the higher incidence of post-procedure gastroesophageal reflux disease (GERD), occurring in up to 50-60% of patients. In order to reduce the risk of GERD, endoscopic fundoplication has been developed as a novel procedure mimicking surgical anterior partial fundoplication that can be performed in the same session as POEM (POEM-F). Case series of POEM-F in patients with achalasia reported encouraging outcomes of low GERD rate of \~12% at 1 year. Prospective comparative data between POEM-F and conventional POEM on post-procedure GERD is current lacking. The investigators therefore designed an international multicenter prospective randomized study to investigate the efficacy of POEM-F. The investigators postulate that POEM-F could reduce the incidence of post-procedure GERD when compared with conventional POEM. This is an international multicenter randomized controlled trial conducted between high volume expert centers from Hong Kong SAR, China, India and United States of America. Adult patients with manometry confirmed achalasia would be randomised to undergo POEM-F or POEM. The procedure would be performed by experts with vast experience in POEM. The primary outcome is the incidence of post-procedure GERD at 1 year, defined by the updated Lyon consensus. Secondary outcomes include technical and clinical success rates, adverse events, post-POEM endoscopic and manometry findings as well as patients' symptom scores. Sample size calculation Based on existing pilot comparative data on POEM-F and POEM, it is estimated that 84 patients would be required to demonstrate a difference in post-procedure GERD of 47.6% to 18.2%, with 80% power and false positive rate of 0.05, accounting for 10% loss to follow-up. Purpose and potential The current study proposal could demonstrate the superiority of POEM-F over POEM in reducing post-procedural GERD. It would also demonstrate the safety and reproducibility of the technique in expert centers across the globe. It could potentially replace conventional POEM as the preferred minimally invasive endoscopic treatment for achalasia.

Conditions

Achalasia

Keywords

POEM; Fundoplication; GERD

Outcome Measures

Primary Outcomes (1)

• Post-procedure rate of gastroesophageal reflux

  Defined by updated Lyon 2.0 consensus as fulfilling one or more of the criteria: 1. Endoscopic erosive esophagitis, LA grade B or above 2. Long segment Barrett's esophagus 3. Peptic esophageal stricture 4. 24-hour pH study with acid exposure time \>6% Both endoscopy and pH study to be performed with proton pump inhibitor stopped for 4 weeks

  1 year

Secondary Outcomes (18)

• Clinical success rate of procedure

  1 year

• Adverse event of procedure

  30 day

• Technical success rate of procedure

  1 day

• Procedure time

  1 day

• Erosive esophagitis on post-procedure endoscopy

  1 year

Study Arms (2)

Per-oral endoscopic myotomy with fundoplication

EXPERIMENTAL

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.

Procedure: POEM-F

Conventional POEM

ACTIVE COMPARATOR

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

Procedure: Conventional POEM

Interventions

POEM-F PROCEDURE

POEM-F would be performed as described in the arms section

Per-oral endoscopic myotomy with fundoplication

Conventional POEM PROCEDURE

Anterior POEM performed as described in the arms section

Conventional POEM

Eligibility Criteria

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

You may qualify if:

• Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II.
• Capability of understanding and complying with the study requirements, including filling the Eckardt Score, GERD-HRQL and RSI questionnaire and signing the informed consent form.
• Patients with achalasia type I, II or III who are one of the following:
• Treatment naïve, or
• Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation

You may not qualify if:

• Patients unable or unwilling to provide consent.
• Previous esophageal or gastric surgery.
• Prior achalasia treatment including Heller myotomy, POEM.
• Sigmoid achalasia, or significant esophageal dilatation \>6cm in lower esophagus
• Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc
• Patients with large hiatal hernias (axial length \> 2 cm and Hill grade \>2).
• Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.
• Patients with obesity (Body Mass Index (BMI) ≥ 30).
• Pregnant women or those planning pregnancy or breastfeeding women.
• Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Deenanath Mangeshkar Hospital and Research Centre: collaborator
• Johns Hopkins University: collaborator
• Northwestern University Feinberg School of Medicine: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Asian Institute of Gastroenterology, India: collaborator
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator

Study Sites (7)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, China

NOT YET RECRUITING

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Post Graduate Institute of Medical Education and Research

Chandigarh, India

NOT YET RECRUITING

Asian Institute of Gastroenterology

Hyderabad, India

NOT YET RECRUITING

Baldota Institute of Digestive Sciences

Mumbai, India

NOT YET RECRUITING

Deenanath Mangeshkar Hospital & Research Center

Pune, India

NOT YET RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia; Gastroesophageal Reflux

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 18, 2023
• Study Start: December 1, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); US (1); IN (4); CN (1)