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Assessment of Different Modified POEM for Achalasia

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ClinicalTrials.gov Identifier: NCT04578769
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Tao Guo, Peking Union Medical College Hospital

Brief Summary:
The aims of this study are 1) to compare the efficacy and safety of conventional myotomy (long myotomy) and modified myotomy (short myotomy) in the treatment of type I/II achalasia patients diagnosed according to Chicago Classification; 2) to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of type I/II achalasia patients; 3) to compare the efficacy and safety of conventional myotomy (non-tailored myotomy) and modified myotomy (tailored myotomy) in the treatment of type III achalasia patients.

Condition or disease Intervention/treatment Phase
Esophageal Achalasia Procedure: conventional myotomy Procedure: short myotomy Procedure: full-thickness myotomy Procedure: tailored myotomy Not Applicable

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), but there is no guideline or expert consensus with regard to minimal myotomy length recommended in POEM.

Based on the facts that achalasia is a primary motor disorder of LES dysfunction, patients with type I/II achalasia may achieve a satisfactory outcome with shorter myotomy in procedure of modified POEM, which only focused on the forced relaxation of the LES. Recently, some retrospective studies have suggested that shorter myotomy is comparable with longer myotomy for treating achalasia with regard to clinical efficacy and has the advantage of shorter procedure time, which needs to be further confirmed by more prospective studies.

In terms with the International Peroral Endoscopic Myotomy Survey, a longer myotomy is recommended for patients with type III achalasia. The length of myotomy in type III achalasia can be gauged by high-resolution manometry (HRM). Recent research showed that postoperative Eckardt score was significantly improved in the tailored group (myotomy length informed by HRM) versus non-tailored for type III achalasia, but this study was limited by its retrospective nature.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Study of Conventional Peroral Endoscopic Myotomy (POEM) and Different Modified Procedures of POEM for Achalasia
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: conventional myotomy
conventional myotomy for achalasia type I, II and III
Procedure: conventional 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.
Other Names:
  • long myotomy
  • circular myotomy
  • non-tailored myotomy

Experimental: short myotomy
modified myotomy (short myotomy) for achalasia type I and II
Procedure: short myotomy
  1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 6 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.
Other Name: modified myotomy

Experimental: full-thickness myotomy
modified myotomy (full-thickness myotomy) for achalasia type I and II
Procedure: full-thickness 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.
Other Name: modified myotomy

Experimental: tailored myotomy
modified myotomy (tailored myotomy) for achalasia type III
Procedure: tailored myotomy
  1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 2 cm proximal to the spastic segment within the esophageal body, which is identified based on information gained from high-resolution manometry (HRM).
  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.
Other Name: modified myotomy




Primary Outcome Measures :
  1. Therapeutic success of short term [ Time Frame: 6 months after the procedure ]
    Therapeutic success is defined as a reduction in the Eckardt score to ≤3. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 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) (Eckardt, V. Gastroenterology, 1992. 103(6): 1732-8.

  2. Therapeutic success of long term [ Time Frame: 2 years after the procedure ]
    Therapeutic success is defined as a reduction in the Eckardt score to ≤3.

  3. 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.)

  4. Rate of GERD [ Time Frame: 2 years after the procedure ]
    Gastro-esophageal reflux disease (GERD) is identified by positive results of esophageal pH-impedance/pH-monitoring (DeMeester score), gastro-esophageal reflux symptom assessment (GerdQ questionnaire) or esophagogastroduodenoscopy (reflux esophagitis).


Secondary Outcome Measures :
  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: 2 years after the procedure ]
    Basal lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP)

  3. Change in barium column height by barium esophagogram [ Time Frame: 2 years after the procedure ]
    Barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes



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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects diagnosed as achalasia type I, II, or III on the basis of the results of established methods (barium swallow, manometry, esophagogastroduodenoscopy)
  • Candidate for a POEM
  • No contra-indication to general anesthesia
  • Their age is ≥14years and ≤70 years
  • Able to give written consent

Exclusion Criteria:

  • Previous myotomy for achalasia: any of previous Heller myotomy, endoscopic myotomy
  • Previous mediastinal surgery
  • Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow, esophageal diverticula or hiatal hernia.
  • Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
  • Pregnant or lactating female
  • Subjects with coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578769


Contacts
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Contact: Tao Guo, MD 8610-69155017 guoqiong990@126.com

Locations
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China, Beijing
Department of Gastroenterology, Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Tao Guo, MD    8610-69155017    guoqiong990@126.com   
Principal Investigator: Tao Guo, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Tao Guo, MD Peking Union Medical College Hospital
Publications:

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Responsible Party: Tao Guo, Associated professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04578769    
Other Study ID Numbers: PUMCH-POEM-1
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tao Guo, Peking Union Medical College Hospital:
peroral endoscopic myotomy
Achalasia
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases