- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04798547
Short Vs Standard Length Myotomy in Achalasia
Outcomes of Short-length vs Standard-length Myotomy Using Per-Oral Endoscopic Myotomy (POEM) for Achalasia: A Randomized Controlled Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND:
Achalasia is a disorder of esophageal dysmotility characterized by dysfunctional peristalsis and increased lower esophageal sphincter (LES) tone. Achalasia is further divided into three subtypes using high-resolution manometry (HRM) following the Chicago Classification. Type I, or classic achalasia, and Type II achalasia are both characterized by aperistalsis and increased LES tone and are thought to be a spectrum of the same disease process with Type II evolving into Type I.
Per-oral Endoscopic Myotomy (POEM) was first developed in 2008 as a treatment for achalasia. The technique involves a trans-oral approach with a flexible endoscope. An endoscopic incision is made in the esophagus and a submucosal tract is created towards the LES and gastric cardia to expose the underlying muscle of the LES and distal esophagus. The inner circular muscle is then dissected to create a myotomy and the tract is then closed with endoscopic clips. By creating a myotomy, the increased LES tone is improved, allowing food to pass into the stomach in order to relieve the dysphagia caused by achalasia.
Unlike Type III achalasia, where POEM myotomy length is determined by HRM, the standard myotomy length in Type I/Type II achalasia is typically 8 cm. The rationale for the 8 cm myotomy is derived from the Heller myotomy procedure which is a laparoscopic surgery approach in which the teaching has been to perform at least a 5 cm myotomy in the esophagus and an additional 2-3 cm myotomy in the gastric cardia. However, the purpose of the myotomy in POEM, is to reduce the LES tone. The clinical efficacy of the procedure comes from the myotomy of the high pressure zone within the LES, which is only 2-3cm in length. This is much shorter than the current standard POEM myotomy length. There are a few potential pitfalls regarding longer myotomy lengths in the esophagus and in the gastric cardia. A longer esophageal myotomy may result in esophageal wall strain in the area weakened by esophageal myotomy resulting in a blown out myotomy which is identified by the presence of a pseudo-diverticulum endoscopically. Longer gastric cardia myotomy has been thought to lead to an increased rate of gastroesophageal reflux in patients undergoing POEM. There are no data looking at shorter myotomy lengths in POEM for Type I and Type II achalasia. Our anecdotal experience at Northwestern when performing short myotomy during POEM has not resulted in any difference in procedural efficacy.
STUDY ENDPOINTS:
Upon enrollment, patients will complete the Eckardt study questionnaire and the GERDQ questionnaire on the initial visit. Enrolled subjects will complete POEM as per clinical standard of care with the following specifications. Patients will be randomized to receive a short myotomy of 4 cm or standard myotomy of 8 cm. Following POEM, patients will be followed in clinic per standard of care and study questionnaires will be administered at follow-up visits. The Eckardt Symptom score is validated for research use in achalasia and is the tool with which we monitor success rates for treatment of achalasia. We will also monitor GERD symptoms with the GERDQ questionnaire. The endpoints for this study following randomization and completion of 30 POEM procedures are:
- 3, 12 and 24-months of follow-up to monitor Eckardt score for all 30 participants
- 3, 12 and 14-months of follow-up to monitor safety and GERD for all 30 participants
PROCEDURES INVOLVED:
Patients will be recruited from the pool of patients seen in esophageal clinics and endoscopy centers at Northwestern's Digestive Health Center who are specifically consented to undergo POEM for Type I or Type II achalasia and also in patients with EGJ outflow obstruction that demonstrate features of achalasia. Involvement with the study will not determine or affect eligibility or recommendation for POEM in the treatment of achalasia. Upon enrollment, patients will complete all study questionnaires on the initial visit - these include our GERDQ questionnaire and our Northwestern Esophageal Quality of Life Survey.
Following enrollment, 30 patients will be randomized to receive either a 4 cm or 8 cm myotomy. Randomization will occur via computer randomization software. At the time of the procedure, the endoscopist will be given the randomized grouping in an opaque envelope (either 4 cm or 8 cm myotomy). Participants will then undergo Per-Oral Endoscopic Myotomy as per standard of care with flexible endoscope using an anterior approach. The only difference in the procedure will be the length of the muscle layer dissection (myotomy). Fifteen subjects will undergo the standard 8 cm myotomy, which includes 7 cm myotomy of the esophagus and 1 cm myotomy of the gastric cardia. Fifteen subjects will undergo a short 4 cm myotomy, which includes 3 cm myotomy in the esophagus and a 1 cm myotomy of the gastric cardia. All participants will undergo intra-operative functional monitoring as is standard of care at Northwestern to ensure adequate response to myotomy. If the shorter myotomy is insufficient, the patient can undergo standard-length myotomy.
Participants will be monitored as per standard care before, during and after POEM procedure. Post-procedure follow-up for both groups will adhere to standard of care. Data will be collected on a prospective data from EPIC electronic health care records. Data collected will include demographic information, imaging results, functional studies (specifically EndoFlip and HRM) as well as questionnaire data.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients aged 18+ diagnosed with Type I or Type II achalasia, and patients with EGJ Outflow Obstruction with features of achalasia based on HRM or Endoscopic Functional Lumen Imaging Probe (EndoFLIP)
- All subjects must have given signed, informed consent prior to registration in the study
Exclusion Criteria:
- Patient with Type III achalasia or spastic esophageal dysmotility disorders requiring long myotomy as determined by HRM
- All patients who are unable or unwilling to give consent will not be included in the study
- Patients who are pregnant, vulnerable populations such as prisoners, life expectancy < 1 year based on concurrent comorbidities, coagulopathy with INR > 1.5 that cannot be reversed, thrombocytopenia with platelets < 50,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope.
- Patients who have already undergone treatment with POEM or Heller Myotomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Standard Length Myotomy
Patients randomized to received 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for achalasia
|
Standard Length Myotomy
|
Experimental: Short Length Myotomy
Patients randomized to received 4 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for achalasia
|
Evaluation of short length myotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare symptomatic improvement of achalasia based on Eckardt Score following POEM with 4 cm myotomy vs 8 cm myotomy
Time Frame: 2 years
|
At 1, 6 and 12 months, patient reported outcome of achalasia symptoms will be assessed.
The Eckardt Score is a validated research tool for achalasia symptoms.
Scores range from 0-12.
A higher score indicates worse symptoms.
We will compare Eckardt Score pre-POEM and post-PEM at various time points.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare procedure complications after 4 cm myotomy with POEM compared to 8 cm myotomy with POEM
Time Frame: 1 year
|
We will monitor for any evidence of complications post-procedure including bleeding, perforation and blown-out myotomy.
|
1 year
|
Compare procedural time and intra-procedural findings between 4 cm myotomy with POEM compared to 8 cm myotomy with POEM
Time Frame: 1 year
|
We will record procedure times and procedural findings including submucosal tunnel length, position of myotomy, cautery settings for myotomy, need for revision of myotomy and endoclips used for tunnel closure.
|
1 year
|
Compare post-POEM gastro-esophageal reflux between 4 cm myotomy and 8 cm myotomy using GERDQ assessment.
Time Frame: 2 years
|
At 1, 6 and 12 months, patient reported outcome of acid reflux will be assessed.
The GERDQ is a validated survey tool to assess acid reflux symptoms.
Scores range from 0-18 with a higher score indicating worse symptoms.
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.
- Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
- Chen WF, Li QL, Zhou PH, Yao LQ, Xu MD, Zhang YQ, Zhong YS, Ma LL, Qin WZ, Hu JW, Cai MY, He MJ, Cui Z. Long-term outcomes of peroral endoscopic myotomy for achalasia in pediatric patients: a prospective, single-center study. Gastrointest Endosc. 2015 Jan;81(1):91-100. doi: 10.1016/j.gie.2014.06.035. Epub 2014 Aug 1.
- Hungness ES, Sternbach JM, Teitelbaum EN, Kahrilas PJ, Pandolfino JE, Soper NJ. Per-oral Endoscopic Myotomy (POEM) After the Learning Curve: Durable Long-term Results With a Low Complication Rate. Ann Surg. 2016 Sep;264(3):508-17. doi: 10.1097/SLA.0000000000001870.
- Laurino-Neto RM, Herbella F, Schlottmann F, Patti M. EVALUATION OF ESOPHAGEAL ACHALASIA: FROM SYMPTOMS TO THE CHICAGO CLASSIFICATION. Arq Bras Cir Dig. 2018;31(2):e1376. doi: 10.1590/0102-672020180001e1376. Epub 2018 Jul 2.
- Taft TH, Carlson DA, Triggs J, Craft J, Starkey K, Yadlapati R, Gregory D, Pandolfino JE. Evaluating the reliability and construct validity of the Eckardt symptom score as a measure of achalasia severity. Neurogastroenterol Motil. 2018 Jun;30(6):e13287. doi: 10.1111/nmo.13287. Epub 2018 Jan 8.
- Kahrilas PJ, Boeckxstaens G. The spectrum of achalasia: lessons from studies of pathophysiology and high-resolution manometry. Gastroenterology. 2013 Nov;145(5):954-65. doi: 10.1053/j.gastro.2013.08.038. Epub 2013 Aug 21.
- Boeckxstaens GE, Zaninotto G, Richter JE. Achalasia. Lancet. 2014 Jan 4;383(9911):83-93. doi: 10.1016/S0140-6736(13)60651-0. Epub 2013 Jul 17.
- Pandolfino JE, Kwiatek MA, Nealis T, Bulsiewicz W, Post J, Kahrilas PJ. Achalasia: a new clinically relevant classification by high-resolution manometry. Gastroenterology. 2008 Nov;135(5):1526-33. doi: 10.1053/j.gastro.2008.07.022. Epub 2008 Jul 22.
- Spechler SJ, Castell DO. Classification of oesophageal motility abnormalities. Gut. 2001 Jul;49(1):145-51. doi: 10.1136/gut.49.1.145.
- Pandolfino JE, Kahrilas PJ; American Gastroenterological Association. AGA technical review on the clinical use of esophageal manometry. Gastroenterology. 2005 Jan;128(1):209-24. doi: 10.1053/j.gastro.2004.11.008. No abstract available.
- Kahrilas PJ, Katzka D, Richter JE. Clinical Practice Update: The Use of Per-Oral Endoscopic Myotomy in Achalasia: Expert Review and Best Practice Advice From the AGA Institute. Gastroenterology. 2017 Nov;153(5):1205-1211. doi: 10.1053/j.gastro.2017.10.001. Epub 2017 Oct 6.
- Kane ED, Budhraja V, Desilets DJ, Romanelli JR. Myotomy length informed by high-resolution esophageal manometry (HREM) results in improved per-oral endoscopic myotomy (POEM) outcomes for type III achalasia. Surg Endosc. 2019 Mar;33(3):886-894. doi: 10.1007/s00464-018-6356-0. Epub 2018 Jul 27.
- Li QL, Chen WF, Zhou PH, Yao LQ, Xu MD, Hu JW, Cai MY, Zhang YQ, Qin WZ, Ren Z. Peroral endoscopic myotomy for the treatment of achalasia: a clinical comparative study of endoscopic full-thickness and circular muscle myotomy. J Am Coll Surg. 2013 Sep;217(3):442-51. doi: 10.1016/j.jamcollsurg.2013.04.033. Epub 2013 Jul 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00212053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Achalasia
-
Zeng ChanghaoRecruitingCricopharyngeal AchalasiaTaiwan
-
Copka SonpashanNot yet recruitingCricopharyngeal Achalasia
-
Germans Trias i Pujol HospitalActive, not recruiting
-
Govind Ballabh Pant HospitalActive, not recruitingAchalasia CardiaIndia
-
Asian Institute of Gastroenterology, IndiaUnknown
-
University Hospital, Strasbourg, FranceCompleted
-
Hospices Civils de LyonCompleted
-
Cairo UniversityRecruitingAchalasia | Achalasia CardiaEgypt
-
Mayo ClinicTerminatedAchalasia | Esophageal Achalasia | Achalasia, EsophagealUnited States
-
Federico II UniversityCompleted
Clinical Trials on Standard Length Myotomy
-
Northwestern UniversityCompleted
-
Nanfang Hospital of Southern Medical UniversityUnknownEsophageal Motility Disorders | Esophageal AchalasiaChina
-
Peking Union Medical College HospitalRecruiting
-
Massachusetts General HospitalCompleted
-
The Oregon ClinicCompleted
-
Karolinska University HospitalErsta Hospital, SwedenCompleted
-
The Oregon ClinicUnknownEsophageal Motility DisordersUnited States
-
Hillel Yaffe Medical CenterUnknown
-
Asan Medical CenterUnknown