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Esophageal AchalasiaNCT04578769

Assessment of Different Modified POEM for Achalasia

A study testing conventional myotomy and full-thickness myotomy in people with Esophageal Achalasia, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
Esophageal Achalasia
What is being tested?
conventional myotomy and full-thickness myotomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteChina
Study dates
2 Sep 2020to 30 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Gastroenterology, Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Comparison Study of Conventional Peroral Endoscopic Myotomy (POEM) and Different Modified Procedures of 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.

Read the detailed description

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.

Being tested
conventional myotomy, full-thickness myotomy
Keywords
peroral endoscopic myotomy, Achalasia, thickness of myotomy
Medical subject headings
Esophageal Achalasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional myotomyProcedure or surgery

    Also called circular myotomy, non-tailored myotomy

    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 or surgery

    Also called modified myotomy

    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.
Study groups in NCT04578769
Study groupRoleWhat they receive
conventional myotomyActive comparatorconventional myotomy for achalasia type I or II
Receives: Procedure: conventional myotomy
full-thickness myotomyExperimentalmodified myotomy (full-thickness myotomy) for achalasia type I or II
Receives: Procedure: full-thickness myotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months after the procedure

Secondary outcomes (9)

  1. 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.

    Measured: During the endoscopic procedure

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

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

    Measured: 6 month after the procedure

  3. barium esophagogram

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

    Measured: 6 month after the procedure

  4. Rate of intra-procedure complications

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

    Measured: During the endoscopic procedure

  5. the rate and severity of oesophagitis

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

    Measured: 6 months after the procedure

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

    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.

    Measured: 6-month after the procedure

  7. POEM difficulty evaluation

    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

    Measured: During the endoscopic procedure

  8. perioperative hospitalization

    perioperative hospitalization length

    Measured: perioperative period

  9. post-POEM persistent pain

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

    Measured: postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start2 Sep 2020
  3. Primary completion30 Dec 2025
  4. Study completion30 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04578769
Sponsor's protocol ID
PUMCH-POEM-1
Status last verified
Dec 2025
First submitted
26 Sep 2020
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25469569

  • Inoue H, Shiwaku H, Kobayashi Y, Chiu PWY, Hawes RH, Neuhaus H, Costamagna G, Stavropoulos SN, Fukami N, Seewald S, Onimaru M, Minami H, Tanaka S, Shimamura Y, Santi EG, Grimes K, Tajiri H. Statement for gastroesophageal reflux disease after peroral endoscopic myotomy from an international multicenter experience. Esophagus. 2020 Jan;17(1):3-10. doi: 10.1007/s10388-019-00689-6. Epub 2019 Sep 26.

    PubMed 31559513

  • Inoue H, Shiwaku H, Iwakiri K, Onimaru M, Kobayashi Y, Minami H, Sato H, Kitano S, Iwakiri R, Omura N, Murakami K, Fukami N, Fujimoto K, Tajiri H. Clinical practice guidelines for peroral endoscopic myotomy. Dig Endosc. 2018 Sep;30(5):563-579. doi: 10.1111/den.13239.

    PubMed 30022514

  • Wang J, Tan N, Xiao Y, Chen J, Chen B, Ma Z, Zhang D, Chen M, Cui Y. Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study. Dis Esophagus. 2015 Nov-Dec;28(8):720-7. doi: 10.1111/dote.12280. Epub 2014 Sep 12.

    PubMed 25214469

  • Li L, Chai N, Linghu E, Li Z, Du C, Zhang W, Zou J, Xiong Y, Zhang X, Tang P. Safety and efficacy of using a short tunnel versus a standard tunnel for peroral endoscopic myotomy for Ling type IIc and III achalasia: a retrospective study. Surg Endosc. 2019 May;33(5):1394-1402. doi: 10.1007/s00464-018-6414-7. Epub 2018 Sep 5.

    PubMed 30187204

  • 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.

    PubMed 30054739

  • Wang XH, Tan YY, Zhu HY, Li CJ, Liu DL. Full-thickness myotomy is associated with higher rate of postoperative gastroesophageal reflux disease. World J Gastroenterol. 2016 Nov 14;22(42):9419-9426. doi: 10.3748/wjg.v22.i42.9419.

    PubMed 27895430

  • 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.

    PubMed 23891074

Questions about this trial

What is this clinical trial studying?

A study testing conventional myotomy and full-thickness myotomy in people with Esophageal Achalasia, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic success of short term (time frame: 6 months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04578769, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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