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

NCT ID: NCT03186248

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-03-20

Brief Summary

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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.

Detailed Description

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The primary goal of treatment of achalasia cardia (either LHM or POEM) is to divide the muscle at LES to reduce the pressure so that food bolus can pass down into the esophagus. However, there is little evidence regarding the optimal length of this myotomy for either procedure. During LHM the proximal length of myotomy is extended upto 6-8 cm in esophagus and distally to 3 cm in stomach. There are no data on long term outcomes between differential proximal myotomy lengths. The conventionally the esophageal myotomy is extended to 6-8 cm, this is based on technical considerations, as it is the maximum length that can safely be achieved via a laparoscopic, transhiatal approach. High pressure zone of Esophago gastric junction (EGJ) complex extends for 4 cm on an average with 2 cm on esophageal side. It is hypothesized that If shorter proximal myotomy that ablates just the EGJ complex could achieve the same normalization of EGJ physiology as a longer one, there could be several advantages to this modification. It will take less mediastinal dissection of the esophagus, potentially reducing the chances of esophageal perforation, vagal injury and pleural tears. During POEM, a shorter myotomy would allow for creation of a shorter submucosal tunnel, decreasing operative time along with potentially decreasing the incidence of mucosal perforations, pneumothorax and pneumoperitoneum. Additionally, there is chance that many patients regain some esophageal peristalsis after both LHM and POEM. Patients undergoing POEM for type 1 and type 2 Achalasia cardia will be randomised into 2 groups of short oesophageal (3 cm) and long oesophageal ( 6-8 cm) myotomy.

Conditions

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Achalasia Cardia

Keywords

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Achalasia cardia myotomy Per oral endoscopic myotomy laparoscopic fundoplication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double blind randomized clinical trial

Study Groups

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Short myotomy

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

Group Type EXPERIMENTAL

Per oral endoscopic myotomy

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Per oral endoscopic myotomy

Intervention Type 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.

Interventions

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Per oral endoscopic myotomy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asian Institute of Gastroenterology, India

OTHER

Sponsor Role lead

Responsible Party

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Mohan Ramchandani

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mahiboob sayyed, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Institute of Gastroenterology

Locations

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Mohan Ramchandani

Hyderabad, Telangana, India

Site Status

Countries

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India

Other Identifiers

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AIG- 09/05

Identifier Type: -

Identifier Source: org_study_id