Esophageal AchalasiaNCT01742494
Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
A study testing Water-jet POEM and Conventional POEM in people with Esophageal Achalasia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- Water-jet POEM and Conventional POEM
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Dec 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
- Pseudoachalasia
- Megaesophagus (diameter of > 7 cm)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ping-Hong Zhou, MD,PhD
About this study
Official title: Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique
Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.
Read the detailed description
Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).
Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)
- Conditions
- Esophageal Achalasia
- Being tested
- Water-jet POEM, Conventional POEM
- Keywords
- Esophageal Achalasia,, Peroral endoscopic myotomy,, Water-jet assisted
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-jet POEMProcedure or surgery
Water-jet assisted POEM procedure was performed
Conventional POEMProcedure or surgery
POEM were performed by the use of conventional technique using injection and triangle tip knife.
| Study group | Role | What they receive |
|---|---|---|
| Water-jet POEM | Active comparator | POEM were performed by the use of Erbe Hybrid knife (WJ group) Receives: Procedure: Water-jet POEM |
| Conventional POEM | Active comparator | POEM were performed by the conventional technique using injection and triangle tip knife (C group). Receives: Procedure: Conventional POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time in both groups
Measured: during POEM procedure
Secondary outcomes (1)
clinical efficacy and safety
bleeding complications, pneumothorax or pleural effusion requiring intervention
Measured: during hospital stay and up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping-Hong Zhou, M.D., PhD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742494
- Sponsor's protocol ID
- Hybrid POEM
- Status last verified
- Dec 2012
- First submitted
- 20 Nov 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cai MY, Zhou PH, Yao LQ, Xu MD, Zhong YS, Li QL, Chen WF, Hu JW, Cui Z, Zhu BQ. Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique. Surg Endosc. 2014 Apr;28(4):1158-65. doi: 10.1007/s00464-013-3300-1.
PubMed 24232052
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique
- ClinicalTrials.gov ID
- NCT01742494
- Acronym / sponsor ID
- Hybrid POEM
- Conditions
- Esophageal Achalasia
- Keywords
- Esophageal Achalasia,, Peroral endoscopic myotomy,, Water-jet assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Dec 2012 (estimated)
- 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.
Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.
Detailed description
Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).
Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water-jet POEM | Active comparator | Procedure: Water-jet POEMPOEM were performed by the use of Erbe Hybrid knife (WJ group) |
| Conventional POEM | Active comparator | Procedure: Conventional POEMPOEM were performed by the conventional technique using injection and triangle tip knife (C group). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
- Pseudoachalasia
- Megaesophagus (diameter of > 7 cm)
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 |
|---|---|---|
| Water-jet POEMWater-jet assisted POEM procedure was performed | Procedure or surgery | Water-jet POEM |
| Conventional POEMPOEM were performed by the use of conventional technique using injection and triangle tip knife. | Procedure or surgery | Conventional POEM |
Primary outcome
Procedure time in both groups
Time frame: during POEM procedure
1 secondary outcome
clinical efficacy and safety
Time frame: during hospital stay and up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Derived from this study: PubMed 24232052Cai MY, Zhou PH, Yao LQ, Xu MD, Zhong YS, Li QL, Chen WF, Hu JW, Cui Z, Zhu BQ. Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique. Surg Endosc. 2014 Apr;28(4):1158-65. doi: 10.1007/s00464-013-3300-1.
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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, M.D., PhD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-jet POEM and Conventional POEM 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 3 inclusion and 3 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 5 Dec 2012. 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 Ping-Hong Zhou, M.D, PhD (86-13681971063, zhou1968@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time in both groups (time frame: during POEM procedure). 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 NCT01742494, which also lists 1 linked publication.
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 5 Dec 2012.