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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01405469
Other study ID # UKE Hamburg Endoscopy PV3725
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date November 2016

Study information

Verified date October 2019
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date November 2016
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- 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.

Exclusion criteria:

- 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

- Barrett's esophagus

- Pregnancy

- Stricture of the esophagus

- Malignant or premalignant esophageal lesion

- Candida esophagitis

- Hiatal hernia > 2cm

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Peroral Endoscopic Myotomy
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

Locations

Country Name City State
Germany Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rösch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3) — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. 3 months after treatment
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 manometry at 3 month after therapy
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 during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment
Secondary Number of Participants With Procedure-related Adverse Events procedure-related adverse events per protocol procedure to 3 months post procedure
Secondary Medication 3 Months After POEM proton pump inhibitor (PPI) use at 3 months after POEM procedure 3 months
Secondary Duration Time Procedure duration time of POEM procedures in minutes procedure
Secondary 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
Secondary cm Myotomy Length myotomy length in 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. 3 months after treatment
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