AchalasiaPOEMNCT01405469
Endoscopic Peroral Myotomy for Treatment of Achalasia
A study testing Peroral Endoscopic Myotomy in people with Achalasia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia
- What is being tested?
- Peroral Endoscopic Myotomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy which are consistent with the diagnosis
- persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
- Signed written informed consent.
Who cannot join
- Patients with previous surgery of the stomach or esophagus
- Patients with known coagulopathy
- Previous achalasia-treatment with surgery
- Patients with liver cirrhosis and/or esophageal varices
- Active esophagitis
- Eosinophilic esophagitis
Show all 12Show fewer
- Barrett's esophagus
- Pregnancy
- Stricture of the esophagus
- Malignant or premalignant esophageal lesion
- Candida esophagitis
- Hiatal hernia > 2cm
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
Hamburg, 20246
About this study
Official title: Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
Read the detailed description
This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy.
Primary outcome:
-eckhardt symptom score 3 month after therapy.
Secondary outcomes:
- Lower esophageal sphincter pressure at 3 month after therapy.
- Reflux symptoms at 3 month after therapy.
For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophagal-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.
- Conditions
- Achalasia
- Being tested
- Peroral Endoscopic Myotomy
- Keywords
- Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy
- Medical subject headings
- Esophageal Achalasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroral Endoscopic MyotomyOther
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips
| Study group | Role | What they receive |
|---|---|---|
| Peroral Endoscopic Myotomy | Experimental | Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxin injection, or to have surgical intervention (Heller myotomy)for treatment Receives: Other: Peroral Endoscopic Myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms.
Measured: 3 months after treatment
Secondary outcomes (8)
mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure
esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure
Measured: manometry at 3 month after therapy
Number of Participants With Reflux Symptoms
Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
Measured: during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
Number of Participants With Procedure-related Adverse Events
procedure-related adverse events per protocol
Measured: procedure to 3 months post procedure
Medication 3 Months After POEM
proton pump inhibitor (PPI) use at 3 months after POEM procedure
Measured: 3 months
Duration Time Procedure
duration time of POEM procedures in minutes
Measured: procedure
Days Duration Hospitalization
participants were followed for the duration of hospital stay, an average of 4 days
Measured: days of hospitalization for POEM procedure, an average of 4 days
cm Myotomy Length
myotomy length in cm
Measured: POEM procedure
Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment
eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals.
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Roesch, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405469
- Sponsor's protocol ID
- UKE Hamburg Endoscopy PV3725
- Acronym
- POEM
- Status last verified
- Oct 2019
- First submitted
- 26 May 2011
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
PubMed 20354937von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
PubMed 22068665
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
- ClinicalTrials.gov ID
- NCT01405469
- Acronym / sponsor ID
- POEM / UKE Hamburg Endoscopy PV3725
- Conditions
- Achalasia
- Keywords
- Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Posted 2 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
Detailed description
This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy.
Primary outcome:
-eckhardt symptom score 3 month after therapy.
Secondary outcomes:
- Lower esophageal sphincter pressure at 3 month after therapy.
- Reflux symptoms at 3 month after therapy.
For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophagal-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peroral Endoscopic Myotomy | Experimental | Other: Peroral Endoscopic MyotomyPatients with achalasia who are designed to either get balloon dilatation or have botulinum toxin injection, or to have surgical intervention (Heller myotomy)for treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy which are consistent with the diagnosis
- persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
- Signed written informed consent.
Key exclusion criteria (12 listed)
- Patients with previous surgery of the stomach or esophagus
- Patients with known coagulopathy
- Previous achalasia-treatment with surgery
- Patients with liver cirrhosis and/or esophageal varices
- Active esophagitis
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 |
|---|---|---|
| Peroral Endoscopic MyotomyA forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips | Other | Peroral Endoscopic Myotomy |
Primary outcome
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3
Time frame: 3 months after treatment
eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms.
8 secondary outcomes
mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure
Time frame: manometry at 3 month after therapy
Number of Participants With Reflux Symptoms
Time frame: during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
Number of Participants With Procedure-related Adverse Events
Time frame: procedure to 3 months post procedure
Medication 3 Months After POEM
Time frame: 3 months
Duration Time Procedure
Time frame: procedure
Days Duration Hospitalization
Time frame: days of hospitalization for POEM procedure, an average of 4 days
cm Myotomy Length
Time frame: POEM procedure
Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment
Time frame: 3 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20354937Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
- Results publication: PubMed 22068665von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
- University Hospital Hamburg-Eppendorf, Endoscopy DepartmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Thomas Roesch, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peroral Endoscopic Myotomy in people with Achalasia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 12 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: finished, as of the sponsor's last update on 15 Oct 2019. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3 (time frame: 3 months after treatment). 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 NCT01405469, which also lists 2 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 15 Oct 2019.