Esophageal AchalasiaNCT03733756
to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)
A study testing POEM preserving longitudinal muscle and POEM involving longitudinal muscle in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- POEM preserving longitudinal muscle and POEM involving longitudinal muscle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed of esophageal achalasia
- Patients or legal surrogates willing and competent to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: 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.
- Conditions
- Esophageal Achalasia
- Being tested
- POEM preserving longitudinal muscle, POEM involving longitudinal muscle
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POEM preserving longitudinal muscleProcedure or surgery
participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
POEM involving longitudinal muscleProcedure or surgery
participants are operated POEM involving both circular and longitudinal muscle
| Study group | Role | What they receive |
|---|---|---|
| POEM preserving longitudinal muscle | Experimental | participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact Receives: Procedure: POEM preserving longitudinal muscle |
| POEM involving longitudinal muscle | Active comparator | participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle Receives: Procedure: POEM involving longitudinal muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after POEM
Secondary outcomes (1)
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.
Measured: 4 weeks after POEM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping-Hong Zhou, MD,PhD, Study chair, Zhongshan Hospital, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733756
- Sponsor's protocol ID
- LM for achalasia
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 20381493Schoeman 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.
PubMed 7828966Liu 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.
PubMed 30261536Mittal 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.
PubMed 15685559
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy
- ClinicalTrials.gov ID
- NCT03733756
- Acronym / sponsor ID
- LM for achalasia
- Conditions
- Esophageal Achalasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POEM preserving longitudinal muscle | Experimental | Procedure: POEM preserving longitudinal muscleparticipants are operated POEM only involving circular muscle, leaving longitudinal muscle intact |
| POEM involving longitudinal muscle | Active comparator | Procedure: POEM involving longitudinal muscleparticipants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed of esophageal achalasia
- Patients or legal surrogates willing and competent to give informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POEM preserving longitudinal muscleparticipants are operated POEM only involving circular muscle, leaving longitudinal muscle intact | Procedure or surgery | POEM preserving longitudinal muscle |
| POEM involving longitudinal muscleparticipants are operated POEM involving both circular and longitudinal muscle | Procedure or surgery | POEM involving longitudinal muscle |
Primary outcome
efficacy of POEM treatment
Time frame: 4 weeks after POEM
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.
1 secondary outcome
complications(GERD) of POEM treatment
Time frame: 4 weeks after POEM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Background: PubMed 20381493Hong 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.
- Background: PubMed 7828966Schoeman 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.
- Background: PubMed 30261536Liu 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.
- Background: PubMed 15685559Mittal 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.
- Individual participant dataSharing planned: Undecided
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Hong Zhou, MD,PhD study chair
Zhongshan Hospital, Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POEM preserving longitudinal muscle and POEM involving longitudinal muscle in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quan-lin Li, MD (+86-021-64041990, liquanlin321@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of POEM treatment (time frame: 4 weeks after POEM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733756, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.