to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)

to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy

Achalasia is a disease characterized by lack of peristalsis and lower esophageal sphincter failing to relax. Longitudinal muscle, outer layer of esophageal smooth muscle, is recently found to be responsible for emptying of esophagus for achalasia patients, especially for those type Ⅱcases. Clinical observations also conclude that type Ⅱ achalasia which still preserve longitudinal muscle response best to treatment, among the 3 types. Thus, with high frequent intraluminal ultrasound, clinically applied as endoscopic ultrasound, to measure the function of longitudinal muscle in achalasia patients, the current research aims to explore the influence of longitudinal muscle on the prognosis of achalasia patients after peroral endoscopic myotomy, a routine treatment.

Study Overview

• Status: Unknown
• Conditions: Esophageal Achalasia
• Intervention / Treatment: Procedure: POEM preserving longitudinal muscle; Procedure: POEM involving longitudinal muscle

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed of esophageal achalasia
• Patients or legal surrogates willing and competent to give informed consent

Exclusion Criteria:

• postoperative or post-POEM
• post-pneumatic dilation or post-stenting
• fail to go through high frequency intraluminal ultrasound （HFIUS)
• Patients with American Society of Anesthesiologists （ASA） score ≥3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POEM preserving longitudinal muscle; participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact	Procedure: POEM preserving longitudinal muscle; participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
Active Comparator: POEM involving longitudinal muscle; participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle	Procedure: POEM involving longitudinal muscle; participants are operated POEM involving both circular and longitudinal muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of POEM treatment	Eckardt score ≤3; Eckardt scale includes 4 items: dysphagia, weight loss, poststernal pain and esophageal reflux, each item ranging from 0-3. The higher the score reaches, the more severe the disease is. It is considered to be efficient if the Eckardt score is ≤3 after POEM.	4 weeks after POEM

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications(GERD) of POEM treatment	gastroesophageal reflux disease questionnaire （GERD-Q） score≥2; GERD-Q scale includes 4 items: post-sternal pain, esophageal reflux, proton pump inhibitor applied, endoscopy identified, each item scoring 0 or 1. The higher the score reaches, the more likely the patient has GERD. It is considered to have a complication as GERD if the GERD-Q ≥2.	4 weeks after POEM

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Ping-Hong Zhou, MD,PhD, Zhongshan Hospital, Fudan University, Shanghai, China

Publications and helpful links

General Publications

• Hong SJ, Bhargava V, Jiang Y, Denboer D, Mittal RK. A unique esophageal motor pattern that involves longitudinal muscles is responsible for emptying in achalasia esophagus. Gastroenterology. 2010 Jul;139(1):102-11. doi: 10.1053/j.gastro.2010.03.058. Epub 2010 Apr 8.
• Schoeman MN, Holloway RH. Secondary oesophageal peristalsis in patients with non-obstructive dysphagia. Gut. 1994 Nov;35(11):1523-8. doi: 10.1136/gut.35.11.1523.
• Liu ZQ, Li QL, Chen WF, Zhang XC, Wu QN, Cai MY, Qin WZ, Hu JW, Zhang YQ, Xu MD, Yao LQ, Zhou PH. The effect of prior treatment on clinical outcomes in patients with achalasia undergoing peroral endoscopic myotomy. Endoscopy. 2019 Apr;51(4):307-316. doi: 10.1055/a-0658-5783. Epub 2018 Sep 27. Erratum In: Endoscopy. 2019 Apr;51(4):C8.
• Mittal RK, Liu J, Puckett JL, Bhalla V, Bhargava V, Tipnis N, Kassab G. Sensory and motor function of the esophagus: lessons from ultrasound imaging. Gastroenterology. 2005 Feb;128(2):487-97. doi: 10.1053/j.gastro.2004.08.004.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 11, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: LM for achalasia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No