Assessment of Different Modified POEM for Achalasia

Peking Union Medical College Hospital52 enrolled

Overview

The aims of this study is to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of achalasia patients.

Peroral endoscopic myotomy (POEM) is a novel clinical technique used to treat achalasia. The conventional POEM myotomy length averages 8 to 10 cm (4-6 cm in the esophagus, 2-4cm in the LES, 2cm in the cardia \& 6-8 cm above and 2 cm below the gastroesophageal junction \[GEJ\]) for typical achalasia (Chicago classification I, II), with only the inner circular muscle layer incised. There is still no conclusion on the thickness of muscle bundle dissection recommended during POEM. Selective circular muscle myotomy is designed to avoid gastroesophageal reflux (GER) postoperatively and decrease morbidity during POEM. But one meta-analysis showed that Heller's surgery could keep patients in long-time remission, mainly because of its full-thickness muscle bundle dissection to make sure of persist relaxation of LES. A retrospective study comparing the outcomes of full-thickness and circular muscle myotomy showed no differences in efficacy, GER or adverse events, although the procedural time was shorter in the full thickness myotomy group. Further randomized controlled trials are warranted to assess the efficacy and safety of different modified myotomy approaches in POEM for patients with achalasia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Esophageal Achalasia

Interventions

conventional myotomyPROCEDURE

1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ. 3. Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 2 cm distal to the GEJ. 4. Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.

full-thickness myotomyPROCEDURE

1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ. 3. Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 4 cm proximal to the GEJ, and a full-thickness muscle myotomy is continually carried out from 4cm proximal to the GEJ down to 2 cm distal to the GEJ. 4. Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosed as achalasia type I or II according to the Chicago Classification Version 4.0, with an Eckardt score \>3 * Their age is ≥14years and ≤70 years * Able to give written consent Exclusion Criteria: * undergone previous surgical treatments * had contra-indication to general anesthesia * previous surgery of the mediastinum, stomach, or esophagus; * Pregnant or lactating female * type III achalasia * current alcohol or drug addiction, mental retardation, severe congenital or acquired coagulopathy (international normalized ratio \>1.6) * hepatic cirrhosis with or without portal hypertension, eosinophilic esophagitis (biopsies were performed at index endoscopy), or confirmed Barrett's esophagus * esophageal diverticula or hiatal hernia based on findings from the index barium esophagram, or other conditions that the investigator believed not appropriate for POEM procedure

Locations (1)

Department of Gastroenterology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Therapeutic success of short term

Clinical severity was assessed using the Eckardt score. This score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of \<5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of \>10 kg). The total score ranges from 0 to 12, with higher scores indicating more severe disease symptomatology. (Eckardt, V. Gastroenterology, 1992. 103(6): 1732-8.

Time frame: 6 months after the procedure

Secondary Outcomes

Procedure time

The duration of the endoscopic procedures for each patients will be calculated, in minutes, since the mucosal incision until the endoscopic closure of the mucosal entry with the last endoscopic clip.

Time frame: During the endoscopic procedure

Pressure changes by high-resolution manometry (HRM)

Basal lower esophageal sphincter (LES) pressure, Distal contractile integral (DCI) and integrated relaxation pressure (IRP)

Time frame: 6 month after the procedure

barium esophagogram

Barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes and esophageal distortion

Time frame: 6 month after the procedure

Rate of intra-procedure complications

Complications encountered during the procedure will be noted. (perforation, delayed bleeding, pneumothorax, subcutaneous emphysema, anastomotic leak etc.)

Time frame: During the endoscopic procedure

the rate and severity of oesophagitis

Central Contacts

Tao Guo, MD

CONTACT

8610-69155017 guoqiong990@126.com

Data from ClinicalTrials.gov

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