Per-oral Endoscopic Myotomy With Fundoplication for Achalasia - an International Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Other Locations
China
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Hong Kong Special Administrative Region
The Chinese University of Hong Kong
RECRUITING
Hong Kong
India
Post Graduate Institute of Medical Education and Research
NOT_YET_RECRUITING
Chandigarh
Asian Institute of Gastroenterology
NOT_YET_RECRUITING
Hyderabad
Baldota Institute of Digestive Sciences
NOT_YET_RECRUITING
Mumbai
Deenanath Mangeshkar Hospital & Research Center
NOT_YET_RECRUITING
Pune
Contact Information
Primary
Hon Chi Yip, FRCSEd
hcyip@surgery.cuhk.edu.hk
35052627
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 81
Treatments
Experimental: Per-oral endoscopic myotomy with fundoplication
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.
Active_comparator: Conventional POEM
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
Sponsors
Collaborators: Deenanath Mangeshkar Hospital and Research Centre, Asian Institute of Gastroenterology, India, Nanfang Hospital, Southern Medical University, Northwestern University Feinberg School of Medicine, Johns Hopkins University, Post Graduate Institute of Medical Education and Research, Chandigarh
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov