Randomized Clinical Trial Comparing Short Versus Long Oesophageal Myotomy in POEM for Achalasia Cardia.

NCT03186248 | Completed DMC

• 1 other identifier: AIG- 09/05
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3 cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM procedures. Principle of POEM is to reduce pressure gradient across LES by Myotomy. Hypothesis is that performing short myotomy will result in similar efficacy in achalasia cardia while reducing the total time taken for the procedure and ultimately will result in less complications.

Conditions

Achalasia Cardia

Keywords

Achalasia cardia; myotomy; Per oral endoscopic myotomy; laparoscopic fundoplication

Outcome Measures

Primary Outcomes (1)

• Comparison of clinical efficacy between short and long myotomy groups

  Clinical success defined as Eckardt score≤3 compared between the two groups

  1 year

Secondary Outcomes (6)

• Difference in operating time between short and long esophageal myotomy during POEM

  Intra-opeartive

• Intraoperative adverse events

  At the time of index procedure

• LES pressure reduction

  1 and 3 months

• Comparison of changes in Eckardt score

  1, 3 and 12 months

• Comparison of gastroesophageal Reflux disease (GERD) Rates

  3 months

Study Arms (2)

Short myotomy

EXPERIMENTAL

Per oral endoscopic myotomy extending from 3 cm cephalad to 3 cm distal to EGJ

Procedure: Per oral endoscopic myotomy

Long myotomy

ACTIVE COMPARATOR

Per oral endoscopic myotomy extending from 6-8cm cephalad to and 3 cm distal to EGJ.

Procedure: Per oral endoscopic myotomy

Interventions

Per oral endoscopic myotomy PROCEDURE

General anesthesia will be administered and an esophagogastroduodenoscopy will be performed. Mucosal incision proximal to the gastroesophageal junction (GEJ) will be identified depending on short or long myotomy. A 1.5- to 2-cm mucosal incision will be performed after raising a submucosal wheal. The endoscope will be inserted to create a submucosal tunnel with a combination of blunt dissection, carbon dioxide insufflation, hydro dissection and careful electrocautery. The tunnel will be extended past the GEJ, 3 cm onto the gastric cardia. after myotomy, the mucosal incision will then be closed using standard endoscopic clips.

Long myotomy; Short myotomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 and 2 achalasia with eckerd score \>3 (0-12 scale achalasia) -.
• Age 18-75 years.
• Treatment naïve or history of pneumatic balloon dilatation.
• Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.

You may not qualify if:

• Type 3 achalasia cardia or any other esophageal motility disorder
• Previous surgery of the esophagus or stomach
• Active severe esophagitis
• Large lower esophageal diverticula
• Large \> 3cm hiatal hernia
• Sigmoid esophagus
• Known gastroesophageal malignancy
• Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
• Cirrhosis with portal hypertension, varices, and/or ascites

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Mohan Ramchandani

Hyderabad, Telangana, 500082, India

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

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

Study Officials

• mahiboob sayyed, MD

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind randomized clinical trial
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Double blind randomized clinical trial

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: June 1, 2017
• Primary Completion: February 15, 2018
• Study Completion: March 20, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)