Back to resultsto Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)
Primary Purpose
Esophageal Achalasia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
POEM preserving longitudinal muscle
POEM involving longitudinal muscle
Sponsored by
About this trial
This is an interventional other trial for Esophageal Achalasia
Eligibility Criteria
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
Sites / Locations
- Zhongshan Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
POEM preserving longitudinal muscle
POEM involving longitudinal muscle
Arm Description
participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03733756
First Posted
November 6, 2018
Last Updated
November 11, 2018
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03733756
Brief Title
to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)
Official Title
to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Achalasia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POEM preserving longitudinal muscle
Arm Type
Experimental
Arm Description
participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
Arm Title
POEM involving longitudinal muscle
Arm Type
Active Comparator
Arm Description
participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle
Intervention Type
Procedure
Intervention Name(s)
POEM preserving longitudinal muscle
Intervention Description
participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
Intervention Type
Procedure
Intervention Name(s)
POEM involving longitudinal muscle
Intervention Description
participants are operated POEM involving both circular and longitudinal muscle
Primary Outcome Measure Information:
Title
efficacy of POEM treatment
Description
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.
Time Frame
4 weeks after POEM
Secondary Outcome Measure Information:
Title
complications(GERD) of POEM treatment
Description
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.
Time Frame
4 weeks after POEM
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan-lin Li, MD
Phone
+86-021-64041990
Email
liquanlin321@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jia-qi Xu, MD
Phone
+86-15221901085
Email
15221901085@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Hong Zhou, MD,PhD
Organizational Affiliation
Zhongshan Hospital, Fudan University, Shanghai, China
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20381493
Citation
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.
Results Reference
background
PubMed Identifier
7828966
Citation
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.
Results Reference
background
PubMed Identifier
30261536
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. 2019 Apr;51(4):307-316. doi: 10.1055/a-0658-5783. Epub 2018 Sep 27. Erratum In: Endoscopy. 2019 Apr;51(4):C8.
Results Reference
background
PubMed Identifier
15685559
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. doi: 10.1053/j.gastro.2004.08.004.
Results Reference
background
Learn more about this trial
to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)
We'll reach out to this number within 24 hrs