Clinical trial NCT01649843: Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia
Official title: Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Achalasia
Keywords: Peroral endoscopic myotomy
Esophageal Achalasia
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus. Unfortunately, no therapy returns normal esophageal function. Treatment is therefore directed at lowering the LES pressure, with the aim of reducing the functional obstruction to bolus transit at this site. Current treatments can be endoscopic or surgical. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers. The investigators purpose was to further evaluate the efficacy and the feasibility of POEM for patients with achalasia in a prospective larger study.

Detailed description: 1. Patients were eligible for enrollment in the study if they had an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)). Exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of \> 7 cm).
2. All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry. Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.
3. The primary outcome of the study was therapeutic success (a reduction in the Eckardt score to ≤3) at the follow-up assessment. The secondary outcomes included procedure-related adverse events, LES pressure on manometry pre- and post POEM, reflux symptoms and medication use before and after POEM, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.

Eligibility criteria: Inclusion Criteria:

* with an Eckardt symptom score ≥ 4
* The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)
* Informed patient consent was obtained

Exclusion Criteria:

* Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
* Pseudoachalasia
* megaesophagus (diameter of \> 7 cm)

Primary outcomes:
measure: Therapeutic success (a reduction in the Eckardt score to ≤3)
timeFrame: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires during follow-up, an expected average of 2 years.
Secondary outcomes:
measure: Procedure-related adverse events
timeFrame: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD.
measure: Lower esophageal sphincter (LES) pressure on manometry
timeFrame: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry
measure: Reflux symptoms and medication use before and after POEM
timeFrame: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires during follow-up, an expected average of 2 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University
Study officials:
affiliation: Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China
name: Ping-Hong Zhou, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Eckardt AJ, Eckardt VF. Treatment and surveillance strategies in achalasia: an update. Nat Rev Gastroenterol Hepatol. 2011 Jun;8(6):311-9. doi: 10.1038/nrgastro.2011.68. Epub 2011 Apr 26.
citation: Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
citation: von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
citation: Ren Z, Zhong Y, Zhou P, Xu M, Cai M, Li L, Shi Q, Yao L. Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases). Surg Endosc. 2012 Nov;26(11):3267-72. doi: 10.1007/s00464-012-2336-y. Epub 2012 May 19.
citation: Hu JW, Li QL, Zhou PH, Yao LQ, Xu MD, Zhang YQ, Zhong YS, Chen WF, Ma LL, Qin WZ, Cai MY. Peroral endoscopic myotomy for advanced achalasia with sigmoid-shaped esophagus: long-term outcomes from a prospective, single-center study. Surg Endosc. 2015 Sep;29(9):2841-50. doi: 10.1007/s00464-014-4013-9. Epub 2014 Dec 10.