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NCT03733756 Clinical Trial

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

Esophageal Achalasia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03733756
Other study ID # LM for achalasia
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date August 31, 2020

Study information
Verified date November 2018
Source Shanghai Zhongshan Hospital
Contact Quan-lin Li, MD
Phone +86-021-64041990
Email liquanlin321@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 308
Est. completion date August 31, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• POEM preserving longitudinal muscle
participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
• POEM involving longitudinal muscle
participants are operated POEM involving both circular and longitudinal muscle

Locations
Country Name City State
China Zhongshan Hospital, Fudan University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. 2018 Sep 27. doi: 10.1055/a-0658-5783. [Epub ahead of print] — View Citation

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. — View Citation

Schoeman MN, Holloway RH. Secondary oesophageal peristalsis in patients with non-obstructive dysphagia. Gut. 1994 Nov;35(11):1523-8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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