Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

NCT ID: NCT01649843

Last Updated: 2012-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Esophageal Achalasia

Keywords

Peroral endoscopic myotomy; Esophageal Achalasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EA

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)).

Group Type: EXPERIMENTAL

POEM

Intervention Type: PROCEDURE

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.

Interventions

POEM

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping-Hong Zhou, MD,PhD

Role: STUDY_DIRECTOR

Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China

Locations

Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ping-Hong Zhou, MD,PhD

Role: CONTACT

Email: zhou1968@yahoo.cn

Facility Contacts

Ping-Hong Zhou, MD,PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 21522116 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20354937 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22068665 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22609984 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25492452 (View on PubMed)

Other Identifiers

Endoscopycenter-POEM

Identifier Type: -

Identifier Source: org_study_id