To Assess the Feasibility of Same Day Discharge Following a POEM Procedure

Esophageal Achalasia Clinical Trial

— POEM2  

Official title:

To Assess the Feasibility of Same Day Discharge Following a POEM Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02572193
• Other study ID #: 2015H1
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2015
• Last updated: December 15, 2016
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: McMaster University
• Contact: Dennis Hong, MD
• Phone: 905-522-1155
• Email: dennishong70[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is being performed to determine if patients can go home on the same day as their procedure.

Description:

This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus.

Standard care for participants includes Heller Myotomy, a laparoscopic procedure that includes cutting the muscle layers in the lower esophageal sphincter (LES) the valve at the bottom of your esophagus. A second procedure is then required to prevent reflux (acid entering the esophagus from the stomach) called fundoplication. Patients with the Heller myotomy will typically stay overnight in hospital. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This procedure uses endoscopy and no incisions to cut one muscle layer. A fundoplication is not required with this method. This study treatment works by entering the surgical area through the mouth and then making an incision (cut) through the esophagus and placing flexible instruments along the outside of the esophagus and down to the LES through a tunnel. The instruments used in this procedure are standard endoscopic instruments that will be provided by one of the leading endoscopic instrument manufacturers, Olympus. The investigators have recently completed a small study showing this procedure is safe and feasible. One observation from this pilot study was that most patients had no pain and didn't need any pain medications. Due to this reason, the investigators think patient's may go home on the same day as their procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Participants must meet ALL of the following inclusion criteria:

• Candidate for a Heller myotomy

• Their age is =18 years and =80 years

• Able to give written consent

Exclusion Criteria:

Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:

• Previous Heller myotomy or POEM procedure

• contra-indication to general anesthesia

• Previous mediastinal surgery hiatal hernia greater than 2 cm

• Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia > 2cm.

• Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure

• Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Achalasia

Intervention

Procedure:
• POEM
To determine the feasibility of same-day discharge following a POEM procedure

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Barbieri LA, Hassan C, Rosati R, Romario UF, Correale L, Repici A. Systematic review and meta-analysis: Efficacy and safety of POEM for achalasia. United European Gastroenterol J. 2015 Aug;3(4):325-34. doi: 10.1177/2050640615581732. — View Citation

Inoue H, Sato H, Ikeda H, Onimaru M, Sato C, Minami H, Yokomichi H, Kobayashi Y, Grimes KL, Kudo SE. Per-Oral Endoscopic Myotomy: A Series of 500 Patients. J Am Coll Surg. 2015 Aug;221(2):256-64. doi: 10.1016/j.jamcollsurg.2015.03.057. — View Citation

Patel K, Abbassi-Ghadi N, Markar S, Kumar S, Jethwa P, Zaninotto G. Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus. 2016 Oct;29(7):807-819. doi: 10.1111/dote.12387. Review. — View Citation

Shiwaku H, Inoue H, Sasaki T, Yamashita K, Ohmiya T, Takeno S, Nimura S, Yamashita Y. A prospective analysis of GERD after POEM on anterior myotomy. Surg Endosc. 2016 Jun;30(6):2496-504. doi: 10.1007/s00464-015-4507-0. — View Citation

Stavropoulos SN, Modayil R, Friedel D. Per oral endoscopic myotomy for the treatment of achalasia. Curr Opin Gastroenterol. 2015 Sep;31(5):430-40. doi: 10.1097/MOG.0000000000000206. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent of patients leaving on post-operative day 0		1 year	No
Secondary	percent of patients who experience post-operative reflux		1 year	No