Assessment of Different Modified POEM for Achalasia
ConditionEsophageal Achalasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-70
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
undergone previous surgical treatments
had contra-indication to general anesthesia
previous surgery of the mediastinum, stomach, or esophagus;
Pregnant or lactating female
Trial design
Design model
Parallel
Treatments tested in this trial
conventional myotomy
Procedure/Surgery1. 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 myotomy
Procedure/Surgery1. 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: conventional myotomyActive comparator 1 intervention
Group B: full-thickness myotomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
6 months after the procedureSecondary outcomes
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.
Time frame
During the endoscopic procedure2
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 procedure3
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 procedure4
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 procedureSponsors and contacts
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Source ClinicalTrials.gov