Personalized Peroral Endoscopic Myotomy for Achalasia

Postoperative Complications Clinical Trial

— POEM  

Official title:

Personalized Peroral Endoscopic Myotomy for Achalasia

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01570621
• Other study ID #: DrumTower206-01
• Status: Unknown status
• Phase: Phase 4
• First received: April 1, 2012
• Last updated: April 3, 2012
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy

• Age over 18 years old

• Signed written informed consent

Exclusion Criteria:

• Patients with previous surgery of the stomach or esophagus

• With known coagulopathy

• Active esophagitis,eosinophilic esophagitis or Barrett's esophagus

• Pregnancy

• Stricture of the esophagus

• Hiatal hernia > 2cm

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia
• Postoperative Complications

Intervention

Procedure:
• peroral endoscopic myotomy
A 3-cm incision is made into the mucosa after injection of saline and methylene blue. A submucosal tunnel is created from the mid-esophagus to the gastric cardia by a triangle-tip knife. The circular muscle fibers or full-thickness muscle are divided by the triangle-tip knife over a length of 6-20 cm on the esophagus, starting 3 cm below the initial mucosal incision, and extended 3-4cm onto the gastric cardia. The mucosal entry site is closed using standard endoscopic clips at last.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

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):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom relief	compare patients' symptoms before and after POEM at 1 month, 12 months.	1-12months
Primary	Lower esophageal sphincter pressure	compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.	1-12months
Primary	improvement of esophageal barium	compare esophageal barium before and after POEM at 1 months,12 months	1-12 months
Primary	Postoperative complications	postoperative complications	0-12months