Endoscopic Peroral Myotomy for Treatment of Achalasia

Achalasia Clinical Trial

— POEM  

Official title:

Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405469
• Other study ID #: UKE Hamburg Endoscopy PV3725
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

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

External Links

•   University Hospital Hamburg-Eppendorf, Endoscopy Department