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Esophageal Mucosal Changes in Achalasia Cardia and Reversibility After Per Oral Endoscopic Myotomy - A Pilot Study

NCT04463095 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-04-16

No results posted yet for this study

Summary

Esophageal mucosal changes in long standing achalasia cardia and reversibility after per oral endoscopic myotomy - A pilot study

Aims and Objectives:

* To study mucosal changes in patients with achalasia cardia
* To study potential malignant histopathological findings in long standing achalasia cardia
* To assess reversibility of mucosal changes after POEM
* To study co-relation of mucosal histopathology with predictors of sub-mucosal fibrosis
* To study muscle biopsy by light microscopy and electron microscopy for viral inclusions

Materials and Methods:

* Study Area - Patients of achalasia cardia undergoing POEM in Asian Institute of Gastroenterology.
* Study Design - Cross sectional study

Inclusion Criteria:

•All patients of achalasia cardia who will undergo POEM and an esophageal mucosal biopsy at 3 months of follow up

Exclusion Criteria:

* Patients of achalasia cardia not undergoing POEM or an esophageal mucosal biopsy at 3 months of follow up
* Upper gastro-intestinal surgically altered anatomy ( apart from previous Heller Myotomy )
* Pregnancy
* Patients not giving consent for participation
* End Point( Length of follow up )- 3 months after POEM - single follow up.

Study Procedure:

Before POEM, all patients will undergo symptom evaluation, esophagogastroduodenoscopy (EGD), high resolution esophageal manometry and timed barium esophagogram.The diagnosis of achalasia will be based on a combination of clinical presentation, esophagogastroduodenoscopy, barium esophagogram and high resolution manometric findings.

Symptoms will be classified by using the Eckardt score.Type of Achalasia will be classified according to the Chicago classification. Esophagus shape (sigmoid vs nonsigmoid), presence of hiatus hernia, presence of esophagitis will be assessed on esophagogastroduodenoscopy. Duration since first symptoms of achalasia will be recorded.

All patients fulfilling the inclusion criteria will undergo Per Oral Endoscopic Myotomy (POEM). During POEM, a mucosal biopsy and a muscle biopsy of the Esophagus will be taken. Patients will be followed up at a single time, 3 months after POEM. During the follow up visit, patients will undergo esophagogastroduodenoscopy guided mucosal biopsy of the Esophagus. Patients will be divided into two groups based on the duration of symptoms of achalasia- Those having symptoms for 1 year or less and those having symptoms for more than 5 years. Histopathological changes in the Esophagus and reversibility of these changes after POEM will be compared between the two study groups to draw a conclusion.

Conditions

  • Histopathology

Interventions

PROCEDURE

PER ORAL ENDOSCOPY MYOTOMY (POEM)

Peroral endoscopic myotomy (POEM)combines thelong-term efficacy of a myotomy with the benefits of an endoscopic, minimally invasive procedure.Other therapeutic options include endoscopic balloon dilatation and surgical myotomy. Endoscopic balloon dilatation is still widely performed because of its relative non-invasiveness and simplicity, but it has a relatively lower success rate and often requires multiple treatment sessions. Surgical myotomy has been thought to be the curative therapeutic choice for symptomatic achalasia. However, it requires skin incisions and additional anti-reflux surgical intervention.Unlike surgical myotomy, POEM preserves the anatomical integrity of the LES and possibly minimizes postoperative reflux.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Dr Pranav Milind Ambardekar, MBBS MD · Asian institute of Gastroenterology/AIG Hospitals

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-01-01
Completion
2021-09-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04463095 on ClinicalTrials.gov