POEM-F for Achalasia International Study
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ClinicalTrials.gov Identifier: NCT06042127 |
Recruitment Status :
Not yet recruiting
First Posted : September 18, 2023
Last Update Posted : September 22, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Achalasia | Procedure: POEM-F Procedure: Conventional POEM | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 81 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomised controlled trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Per-oral Endoscopic Myotomy With Fundoplication for Achalasia - an International Multicenter Randomized Controlled Trial |
Estimated Study Start Date : | November 1, 2023 |
Estimated Primary Completion Date : | October 31, 2025 |
Estimated Study Completion Date : | October 31, 2026 |
Arm | Intervention/treatment |
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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.
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Procedure: POEM-F
POEM-F would be performed as described in the arms section |
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
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Procedure: Conventional POEM
Anterior POEM performed as described in the arms section |
- Post-procedure rate of gastroesophageal reflux [ Time Frame: 1 year ]
Defined by updated Lyon 2.0 consensus as fulfilling one or more of the criteria:
- Endoscopic erosive esophagitis, LA grade B or above
- Long segment Barrett's esophagus
- Peptic esophageal stricture
- 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
- Clinical success rate of procedure [ Time Frame: 1 year ]Post-treatment Eckhardt score <=3
- Adverse event of procedure [ Time Frame: 30 day ]frequency of severe adverse events with probable or definite attribution to the procedure based on the American Society of Gastrointestinal Endoscopy (ASGE) lexicon as well as Clavien Dindo classification
- Technical success rate of procedure [ Time Frame: 1 day ]Completing all steps of the intended procedure successfully in the same session
- Procedure time [ Time Frame: 1 day ]Procedure time of the intended procedure in minutes
- Erosive esophagitis on post-procedure endoscopy [ Time Frame: 1 year ]The presence of erosive esophagitis as well as the grading on post-procedure endoscopy
- Fundoplication wrap integrity on post-procedure endoscopy [ Time Frame: 1 year ]
Endoscopic appearance of fundoplication wrap on retroflexion in the stomach.
- Intact - wrap is completely visualised
- Indistinct - wrap is visualised but appears to be loosened
- Absent - the wrap is completely not visible
- Distensibility index on EndoFLIP, premyotomy [ Time Frame: During index procedure, before myotomy ]Distensibility index (mm2/mmHg) using EndoFLIP
- Distensibility index on EndoFLIP, post myotomy [ Time Frame: During index procedure, after myotomy ]Distensibility index (mm2/mmHg) using EndoFLIP
- Distensibility index on EndoFLIP, post fundoplication [ Time Frame: During index procedure, after fundoplication ]Distensibility index (mm2/mmHg) using EndoFLIP
- Distensibility index on EndoFLIP, on follow-up [ Time Frame: 1 year ]Distensibility index (mm2/mmHg) using EndoFLIP, at follow-up endoscopy
- Maximum diameter on EndoFLIP, premyotomy [ Time Frame: During index procedure, before myotomy ]Maximum diameter (mm) on EndoFLIP
- Maximum diameter on EndoFLIP, post-myotomy [ Time Frame: During index procedure, after myotomy ]Maximum diameter (mm) on EndoFLIP
- Maximum diameter on EndoFLIP, post-fundoplication [ Time Frame: During index procedure, after fundoplication ]Maximum diameter (mm) on EndoFLIP
- Maximum diameter on EndoFLIP, on follow-up [ Time Frame: 1 year ]Maximum diameter (mm) on EndoFLIP, at follow-up endoscopy
- GERD-HRQL score [ Time Frame: 1 month, 3 month, 6 month and 1 year ]Symptom and quality of life score relating to GERD The score ranged from 0-50 with higher score signifying more severe GERD symptom / worse quality of life
- GERD-RSI score [ Time Frame: 1 month, 3 month, 6 month and 1 year ]Symptom and quality of life score relating to GERD The score ranged from 0-45 with higher score signifying more severe GERD symptom
- GERD-Q score [ Time Frame: 1 month, 3 month, 6 month and 1 year ]Symptom and quality of life score relating to GERD The score is ranged from 0-18 with the higher score signifying more symptom of GERD
- Use of proton pump inhibitor post-procedure [ Time Frame: 1 month, 3 month, 6 month, and 1 year ]Number of participants who are on regular / as required / not on PPI
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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.
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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
Exclusion criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06042127
Contact: Hon Chi Yip, FRCSEd | 35052627 | hcyip@surgery.cuhk.edu.hk |
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
Contact: Mouen Khashab mkhasha1@jhmi.edu | |
Sub-Investigator: Farimah Fayyaz | |
Principal Investigator: Mouen Khashab | |
China | |
Nanfang Hospital, Southern Medical University | |
Guangzhou, China | |
Contact: Xiaobei Luo luoxiaobei63@126.com | |
Principal Investigator: Xiaobei Luo | |
Hong Kong | |
The Chinese University of Hong Kong | |
Hong Kong, Hong Kong | |
India | |
Post Graduate Institute of Medical Education and Research | |
Chandigarh, India | |
Contact: Jayanta Samanta dj_samanta@yahoo.co.in | |
Principal Investigator: Jayanta Samanta | |
Asian Institute of Gastroenterology | |
Hyderabad, India | |
Contact: Mohan Ramchandani ramchandanimohan@gmail.com | |
Principal Investigator: Mohan Ramchandani | |
Sub-Investigator: Nabi Zaheer | |
Baldota Institute of Digestive Sciences | |
Mumbai, India | |
Contact: Amit Maydeo amitmaydeo@gmail.com | |
Principal Investigator: Amit Maydeo | |
Sub-Investigator: Gaurav Patil | |
Sub-Investigator: Amat Nagesh | |
Deenanath Mangeshkar Hospital & Research Center | |
Pune, India | |
Contact: Amol Bapaye amolbapaye@gmail.com | |
Principal Investigator: Amol Bapaye |
Principal Investigator: | Hon Chi Yip, FRCSEd | Chinese University of Hong Kong |
Responsible Party: | Hon Chi Yip, Assistant Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT06042127 |
Other Study ID Numbers: |
2023 145-T |
First Posted: | September 18, 2023 Key Record Dates |
Last Update Posted: | September 22, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
POEM Fundoplication GERD |
Esophageal Achalasia Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |