Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peroral Endoscopic Myotomy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | manometry at 3 month after therapy |
| Number of Participants With Reflux Symptoms |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Roesch, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20354937 | Background | 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. | |
| 22068665 | Result | von 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. |
| Label | URL |
|---|---|
| University Hospital Hamburg-Eppendorf, Endoscopy Department | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
16 patients were included as per protocol, no patient was lost during follow-up over a 2 year period
Patients with symptomatic achalasia
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | POEM Patients | pilot group of achalasia patients who received POEM Treatment: Endoscopic Myotomy of the Lower Esophageal Sphincter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | POEM Patients | pilot study, first 16 patients who received POEM for treatment of achalasia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included. | Posted | Mean | Standard Deviation | mmHg | manometry at 3 month after therapy |
|
2 days after POEM
1 cm superficial ulcer (Forrest III) at the cardia
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POEM Patients | pilot group of achalasia patients who received POEM treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 1 cm superficial ulcer (Forrest III) | Gastrointestinal disorders | Systematic Assessment | a 1 cm superficial ulcer (Forrest III) at the cardia was detected on routine EGD, 2 days after POEM. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| treatment failure | Gastrointestinal disorders | Systematic Assessment | eckhardt score 9 three months after POEM |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Thomas Rösch, Principal Investigator | University Hospital Hamburg-Eppendorf | +49 40 7410 50098 | t.roesch@uke.de |
Not provided
| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment |
| 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 | procedure to 3 months post procedure |
| Medication 3 Months After POEM | proton pump inhibitor (PPI) use at 3 months after POEM procedure | 3 months |
| Duration Time Procedure | duration time of POEM procedures in minutes | procedure |
| Days Duration Hospitalization | participants were followed for the duration of hospital stay, an average of 4 days | days of hospitalization for POEM procedure, an average of 4 days |
| cm Myotomy Length | myotomy length in cm | 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. | 3 months after treatment |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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 | Posted | Number | participants | during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment |
|
|
|
| Primary | 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. | Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included. | Posted | Mean | Standard Deviation | Eckardt Score | 3 months after treatment |
|
|
|
|
| Secondary | Number of Participants With Procedure-related Adverse Events | procedure-related adverse events per protocol | Posted | Count of Participants | Participants | procedure to 3 months post procedure |
|
|
|
| Secondary | Medication 3 Months After POEM | proton pump inhibitor (PPI) use at 3 months after POEM procedure | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Duration Time Procedure | duration time of POEM procedures in minutes | Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included. | Posted | Mean | Standard Deviation | minutes | procedure |
|
|
|
| Secondary | Days Duration Hospitalization | participants were followed for the duration of hospital stay, an average of 4 days | Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included. | Posted | Mean | Standard Deviation | days | days of hospitalization for POEM procedure, an average of 4 days |
|
|
|
| Secondary | cm Myotomy Length | myotomy length in cm | Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included. | Posted | Mean | Standard Deviation | cm | POEM procedure |
|
|
|
| Secondary | 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. | Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included. | Posted | Number | percentage of treated patients | 3 months after treatment |
|
|
|
| 2 |
| 16 |
| 1 |
| 16 |
|
| ulcer in the distal esophagus | Gastrointestinal disorders | Non-systematic Assessment | retrosternal pain 3 weeks after POEM. EGD demonstrated an ulcer in the distal esophagus(FIII). The ulcer was clipped |
|
|
Not provided
Not provided
Not provided
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |