NCT04229342

Brief Summary

In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. This is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

April 19, 2024

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

January 7, 2020

Last Update Submit

April 18, 2024

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

  • Significant Reflux Esophagitis, Los Angeles grade (≥grade B)

    Assessment of reflux esophagitis will be done at 8 weeks post procedure using Los Angeles grading system (grade A to D)

    8 weeks

Secondary Outcomes (7)

  • Clinical Success, Eckardt Score (minimum: 0, maximum: 12), Eckardt Score≤3: success, >3: failure

    8 weeks

  • Clinical success using Eckardt Score (minimum:0, maximum: 12)

    6 months

  • Esophageal manometry

    8 weeks

  • Barium column height on Timed barium swallow; Success: >50% reduction in barium column height

    2 months

  • Esophageal acid exposure, Acid exposure time>6 abnormal, <4: normal, 4-6: inconclusive

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Conventional

ACTIVE COMPARATOR

In the "conventional group", standard posterior myotomy will be performed and the sling or the oblique fibers will not be spared beyond the gastroesophageal junction.

Procedure: Per-oral endoscopic myotomy

Oblique or sling fiber sparing group

EXPERIMENTAL

In the oblique or sling fiber group, only the circular muscle fibers will be severed selectively and the sling fibers will be spared

Procedure: Per-oral endoscopic myotomy

Interventions

Per-oral endoscopic myotomyPROCEDURE

Per-oral endoscopic myotomy (POEM) is an endoscopic modality for the management of achalasia cardia. In this study, we will evaluate the impact of two different techniques of posterior POEM on the incidence of gastroesophageal reflux disease (GERD). Posterior POEM will be performed using the standard technique. The myotomy beyond the GEJ will be different in the two groups. In one group, the sling fibers will not be spared from dissection and in the second group, the sling fibers will be selectively spared from myotomy.

ConventionalOblique or sling fiber sparing group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 1 and 2 achalasia with Eckardt score \>3 (0-12 scale achalasia).
  • Patients with age 18-75 years.
  • Patients who are treatment naïve or have a history of pneumatic balloon dilatation.
  • Patients who are 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:

  • Patients with type 3 achalasia cardia or any other esophageal motility disorder,
  • Patients who have undergone previous surgery of the esophagus or stomach,
  • Patients with active severe esophagitis,
  • Patients with large lower esophageal diverticula,
  • Patients with large ( \> 3cm ) hiatal hernia,
  • Patients with sigmoid oesophagus,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500082, India

Location

Related Publications (1)

  • Nabi Z, Chandran V, Basha J, Ramchandani M, Inavolu P, Kalpala R, Goud R, Jagtap N, Darisetty S, Gupta R, Tandan M, Lakhtakia S, Kotla R, Devarasetty R, Rao GV, Reddy DN. Conventional versus oblique fiber-sparing endoscopic myotomy for achalasia cardia: a randomized controlled trial (with videos). Gastrointest Endosc. 2024 Jan;99(1):1-9. doi: 10.1016/j.gie.2023.08.007. Epub 2023 Aug 19.

    PMID: 37598863DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dr. Vincy Chandran, MBBS,MD

    Asian Institute of Gastroenterology Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 18, 2020

Study Start

January 6, 2020

Primary Completion

July 16, 2020

Study Completion

October 6, 2020

Last Updated

April 19, 2024

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)