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

NCT04463095 | Completed DMC

• 1 other identifier: POEM EM
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 1.To study mucosal changes in patients with achalasia cardia

  Number of ganglion cells will be measured in the mucosal biopsy (normal number of ganglion cells are 2 to 12 per mm on Histopathological examination). The size of the ganglion cells will be measured.(normal size of ganglion cells is 10 to 40 microns). Median number of neurons will be measured.(normal median number of neurons are 2 to 6 on histopathological examination).

  12 weeks

• 2. To study potential malignant histopathological findings in long standing achalasia cardia

  The mean Ki-67 and mean p53 positive ratio will be measured in the histopathological examination.

  12 weeks

Secondary Outcomes (2)

• 3.To study co-relation of mucosal histopathology with predictors of sub-mucosal fibrosis

  12 weeks

• 4. To evaluate reversibility of mucosal changes after per oral endoscopic myotomy (POEM )

  12 weeks

Interventions

PER ORAL ENDOSCOPY MYOTOMY (POEM) PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Since the present study is pilot based in assessing the primary outcome, it has been decided to cover 30 patients and follow up at 3 months. Hence no power calculation is used to estimate the sample size.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500082, India

Location

Study Officials

• Dr Pranav Milind Ambardekar, MBBS MD

  Asian institute of Gastroenterology/AIG Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: July 9, 2020
• Study Start: June 30, 2020
• Primary Completion: January 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 16, 2024

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)