Clinical trial NCT02454335: POEM Anterior Versus Posterior Approach
Official title: Comparison of Outcome and Complications of Anterior Versus Posterior Myotomy in Per-oral Endoscopic Myotomy (POEM) Endoscopic Procedure for Treatment of Achalasia: Randomized Single Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achalasia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal achalasia, performed by GI endoscopist without cutting any surface of the human body. The main constituent of the procedure is the myotomy part, through which the endoscopist cuts the muscle fibers in the submucosa. Since this procedure is completely new to the area of treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be followed up for symptoms and complications; data will be extracted and the appropriate analysis will be employed to determine if there is any difference of outcome between the two techniques of myotomy.

Detailed description: Peroral Endoscopic Myotomy (POEM) is an effective, minimally-invasive treatment for achalasia that has been adopted over the past few years. As more programs attempt to adopt the novel technique, there is an increased need for trials to help guide the growth of the procedure. Review of the current literature reveals that most endoscopists prefer an anterior approach, with an incision in the anterior/ anterolateral wall of the esophagus. This approach has been used with tremendous success in decreasing the symptoms of dysphagia and lowering esophageal sphincter (LES) pressure since the first description of the procedure in humans in 2010. However, it can be technically challenging in patients with anterior scarring from prior surgery or radiation, in whom a posterior approach has typically been used. Alternatively, the posterior approach, with incision in the posterolateral wall of the esophagus, has been adopted with great success by several endoscopists as the primary approach to myotomy. Reports involving the posterior approach have also shown significant symptom relief as defined by symptoms score (Eckardt score) \< 3, decreased LES pressure, and low complication rates.

However, despite high rates of technical and clinical success, the posterior approach has not been as widely adopted as the anterior approach. Without comparison of the two approaches in terms of efficacy and safety, the optimal technique to myotomy for POEM is yet to be defined. The investigators main hypothesis is that the posterior myotomy is as efficacious as the anterior myotomy in terms of improvement of achalasia symptoms as indicated by reduction in the Eckardt score and LES pressure. Adaptation of both techniques may increase options in approach for routine POEM and increase the number of patients that are able to undergo the procedure, thereby promoting its applicability.

Eligibility criteria: Inclusion Criteria for Participants

* Adult patient age greater than 18 years old
* Confirmed diagnosis of achalasia via high resolution esophageal manometry (HREM)

Exclusion Criteria

* Previous surgery of the esophagus or stomach
* Active severe esophagitis
* Large lower esophageal diverticula
* Large \> 3cm hiatal hernia
* Sigmoid esophagus
* Known gastroesophageal malignancy
* Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
* Cirrhosis with portal hypertension, varices, and/or ascites
* Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
* Acute gastrointestinal bleeding
* Uncorrectable coagulopathy defined by INR \> 1.5 or platelet \< 50

Primary outcomes:
measure: Change in Eckardt Score
timeFrame: up to 24 months
Secondary outcomes:
measure: Rate of GERD by pH-impedance
timeFrame: up to 24 months
measure: Quality of Life by QoL S36 questionnaire
timeFrame: up to 2 years
measure: Dysphagia by the Dysphagia Score
timeFrame: up to 24 months
measure: Postoperative pain by VAS analogue scale
timeFrame: 2 years
measure: Analgesic use by Analgesic Quantification Algorithm
timeFrame: up to 24 months
measure: Operative and post-operative complications
timeFrame: up to 2 years
measure: Hospital stay in days
timeFrame: up to 24 months
measure: LES pressure by Manometry
timeFrame: up to 2 years
measure: Total procedure time and times of different steps
timeFrame: up to 24 months
measure: Technical success
timeFrame: up to 24 months
measure: Ease of procedure measured by the Lickerdt scale
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References:
citation: Khashab MA, Sanaei O, Rivory J, Eleftheriadis N, Chiu PWY, Shiwaku H, Ogihara K, Ismail A, Abusamaan MS, El Zein MH, Wong VW, Billioux VG, Kumbhari V, Kalloo AN, Ponchon T, Pioche M. Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial. Gastrointest Endosc. 2020 Feb;91(2):288-297.e7. doi: 10.1016/j.gie.2019.07.034. Epub 2019 Aug 10.