Anterior Orientation vs Posterior Orientation in Per Oral Endoscopic Myotomy POEM for the Treatment of Achalasia

NCT03228758 | Completed

• 2 other identifiers: WUH 1700818-01666
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and efficacy of the anterior versus posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of narcotics. The secondary outcomes focus on safety which includes technical procedure duration time; tunneling time, myotomy time, and closure time; incidence of mucosotomy (transmural and non-transmural injury), capnoperitoneum, and the postoperative sequelae of gastrointestinal reflux disease (GERD). Periprocedural pain data collection will include post POEM procedure pain scores, administrations of analgesia until discharge. The final analysis will focus on determining whether there is a statistically significant difference in the amount and severity of pain in the Anterior versus Posterior myotomy subject populations. Additional analysis will be the collection of analgesic type (narcotic versus non-narcotic), dosage, frequency, and duration of treatment from post POEM procedure in the endoscopy recovery suite until the subjects are discharged.

Conditions

Achalasia

Keywords

POEM

Outcome Measures

Primary Outcomes (1)

• Periprocedural pain requiring the use of narcotics.

  Pain related to the endoscopic myotomy requiring the use of narcotic pain medication.

  Within the first 48 hours after the procedure.

Secondary Outcomes (1)

• Incidence of Gastrointestinal Reflux Disease (GERD)

  Within 3 months after the procedure.

Study Arms (2)

Anterior Orientation

ACTIVE COMPARATOR

The anterior endoscopic myotomy of the lower esophageal sphincter will be performed between the 11 o'clock to 3 o'clock position in the esophagus determined by the usual endoscopic convention of 12 o'clock representing the most anterior aspect of the esophagus on endoluminal view. Intervention is the endoscopic myotomy of the lower esophageal sphincter.

Procedure: Per Oral Endoscopic Myotomy

Posterior Orientation

ACTIVE COMPARATOR

The posterior endoscopic myotomy of the lower esophageal sphincter will be performed between the 5 o'clock to 6 o'clock position in the esophagus determined by the usual endoscopic convention of 12 o'clock representing the most anterior aspect of the esophagus on endoluminal view. Intervention is the endoscopic myotomy of the lower esophageal sphincter.

Procedure: Per Oral Endoscopic Myotomy

Interventions

Per Oral Endoscopic Myotomy PROCEDURE

The Per Oral Endoscopic Myotomy procedure is the cutting of the lower esophageal sphincter. This procedure is a natural orifice transluminal endoscopic surgery (NOTES)

Anterior Orientation; Posterior Orientation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have been diagnosed with Achalasia Type I, II, or III by positive manometric findings and supporting findings by timed barium esophagram and endoscopy.
• Subjects who are willing and competent to sign Informed Consent and to comply with study related visits and procedures.

You may not qualify if:

• Subjects who are under 18 years of age
• Subjects with Achalasia Type I, II, or III who have had a prior failed open or laparoscopic Heller myotomy; or have an esophageal diverticula, or anatomical variant dictating the approach of the myotomy
• Subjects diagnosed with other motility disorders such as distal esophageal spasm (DES), hypertensive peristalsis (Nutcracker), or hypercontractile esophagus (Jackhammer)
• Subjects with coagulopathy
• Pregnant females
• Subjects who in the investigators' opinion, are medically unstable , are unable to give informed consent, or whose risks outweigh the benefits of participating in the study
• Subjects with decisional incapacity who are unable to comply with study related visits and procedures

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

Related Publications (12)

• Nguyen NQ, Holloway RH. Recent developments in esophageal motor disorders. Curr Opin Gastroenterol. 2005 Jul;21(4):478-84.

  PMID: 15930992 RESULT

• Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49; quiz 1250. doi: 10.1038/ajg.2013.196. Epub 2013 Jul 23.

  PMID: 23877351 RESULT

• Walzer N, Hirano I. Achalasia. Gastroenterol Clin North Am. 2008 Dec;37(4):807-25, viii. doi: 10.1016/j.gtc.2008.09.002.

  PMID: 19028319 RESULT

• Ruffato A, Mattioli S, Lugaresi ML, D'Ovidio F, Antonacci F, Di Simone MP. Long-term results after Heller-Dor operation for oesophageal achalasia. Eur J Cardiothorac Surg. 2006 Jun;29(6):914-9. doi: 10.1016/j.ejcts.2006.03.044. Epub 2006 May 3.

  PMID: 16675239 RESULT

• Ujiki MB, Yetasook AK, Zapf M, Linn JG, Carbray JM, Denham W. Peroral endoscopic myotomy: A short-term comparison with the standard laparoscopic approach. Surgery. 2013 Oct;154(4):893-7; discussion 897-900. doi: 10.1016/j.surg.2013.04.042.

  PMID: 24074429 RESULT

• 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.

  PMID: 20354937 RESULT

• Richter JE. Update on the management of achalasia: balloons, surgery and drugs. Expert Rev Gastroenterol Hepatol. 2008 Jun;2(3):435-45. doi: 10.1586/17474124.2.3.435.

  PMID: 19072391 RESULT

• Stavropoulos SN, Harris MD, Hida S, Brathwaite C, Demetriou C, Grendell J. Endoscopic submucosal myotomy for the treatment of achalasia (with video). Gastrointest Endosc. 2010 Dec;72(6):1309-11. doi: 10.1016/j.gie.2010.04.016. No abstract available.

  PMID: 21111876 RESULT

• Stavropoulos SN, Modayil RJ, Friedel D, Savides T. The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Surg Endosc. 2013 Sep;27(9):3322-38. doi: 10.1007/s00464-013-2913-8. Epub 2013 Apr 3.

  PMID: 23549760 RESULT

• Stavropoulos, SN, Modayil, R, and Brathwaite, et al. Anterior vs. posterior per oral endoscopic myotomy (POEM): Is there a difference in outcome? Gastrointest Endosc 2016; 83 (5S): AB145

  RESULT

• Friedel D, Modayil R, Stavropoulos SN. Per Oral Endoscopic Myotomy (POEM): review of current techniques and outcomes (including postoperative reflux). Curr Surg Rep 2013; 1: 203-213.

  RESULT

• Stranding, S. (2016) Mediastinum, In Gray's anatomy: the anatomical basis of clinical practice. (41st Ed.). (pp. 976-993) Elsevier Limited in Clinical Key Flex

  RESULT

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Stavros Stavropoulos, MD

  NYU Langone Winthrop

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will not be made aware of the orientation approach to the endoscopic myotomy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either the anterior or posterior orientation approach to the endoscopic myotomy.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 25, 2017
• Study Start: July 24, 2017
• Primary Completion: May 18, 2018
• Study Completion: May 24, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

US (1)