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NCT Number: NCT04578769

Assessment of Different Modified POEM for Achalasia

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.

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Key information

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Tao Guo, MD

CONTACT

[email protected]

8610-69155017

Tao Guo, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional myotomy

Procedure
  • Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ).
  • Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ.
  • 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.
  • Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.

Other names: circular myotomy, non-tailored myotomy

full-thickness myotomy

Procedure
  • Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ).
  • Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ.
  • 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.
  • Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.

Other names: modified myotomy

Primary outcomes

  1. Therapeutic success of short term

    Time frame: 6 months after the procedure

    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.

Secondary outcomes

  1. Procedure time

    Time frame: During the endoscopic procedure

    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.

  2. Pressure changes by high-resolution manometry (HRM)

    Time frame: 6 month after the procedure

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

  3. barium esophagogram

    Time frame: 6 month after the procedure

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

  4. Rate of intra-procedure complications

    Time frame: During the endoscopic procedure

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

  5. the rate and severity of oesophagitis

    Time frame: 6 months after the procedure

    oesphagitis was identified under esophagogastroduodenoscopy, and was classified according to the Los Angeles Classification

  6. (4) Esophagogastroduodenoscopy (EGD) with the novel Endoscopic Scoring for Achalasia (CARS)

    Time frame: 6-month after the procedure

    Endoscopic evaluation was performed using the Contents, Anatomy, Resistance, and Stasis (CARS) score. This scoring system was developed and validated through video-based reliability assessments and initially demonstrated strong clinical utility for predicting achalasia. The score assigns 0 to 2 points each for Contents, Anatomy, and Resistance at the lower esophageal sphincter, and 1 point for each component of Stasis. The total score ranges from 0 to 8, with higher scores indicating a worse endoscopic outcome.

  7. POEM difficulty evaluation

    Time frame: During the endoscopic procedure

    ① Peroral Endoscopic Myotomy (POEM) difficulty score (PDS). The score consists of five variables: Fibrosis, Oozing, Orientation, Distension of tunnel, and Spastic contractions ("FOODS"). Each variable was arbitrarily weighted equally and assigned values ranging from 0 to 2. The PDS was completed immediately post-procedure in the operating room. The total score ranges from 0 to 10, with higher scores indicating greater technical difficulty. ② bleeding episodes, classified into (1) none to minimal (2) moderate to diffuse

  8. perioperative hospitalization

    Time frame: perioperative period

    perioperative hospitalization length

  9. post-POEM persistent pain

    Time frame: postoperative period

    Post-POEM persistent pain was defined as pain requiring level 2 or 3 analgesics.

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Guo, MD

CONTACT

[email protected]

8610-69155017

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Comparison Study of Conventional Peroral Endoscopic Myotomy (POEM) and Different Modified Procedures of POEM for Achalasia

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2020
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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