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

Not Applicable

Completed

• Conditions: Achalasia Cardia
• Interventions: Procedure: Per oral endoscopic myotomy

• Registration Number: NCT03186248
• Lead Sponsor: Asian Institute of Gastroenterology, India

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Primary Completion: 2018-02-15
• Study Completion: 2019-03-20
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-25
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short myotomy	Per oral endoscopic myotomy	Per oral endoscopic myotomy extending from 3 cm cephalad to 3 cm distal to EGJ
Long myotomy	Per oral endoscopic myotomy	Per oral endoscopic myotomy extending from 6-8cm cephalad to and 3 cm distal to EGJ.

Primary Outcome Measures

Name	Time	Method
Comparison of clinical efficacy between short and long myotomy groups	1 year	Clinical success defined as Eckardt score≤3 compared between the two groups

Secondary Outcome Measures

Name	Time	Method
Difference in operating time between short and long esophageal myotomy during POEM	Intra-opeartive	Operating time defined as time taken from mucosal incision to closure of incision after completion of the procedure. Procedure duration was calculated in both the groups and compared
Comparison of gastroesophageal Reflux disease (GERD) Rates	3 months	Both the groups will under go clinical evaluation, esophagograstroscopy and ph metry
Intraoperative adverse events	At the time of index procedure	Adverse events encountered during the procedure will be noted. Clinical success with reference to improvement in eckerd score. Change in LES pressure by Manometry ( Assessed at 1and 3 months) Assessment of Gastro Esophageal Reflux Disease (GERD) by Potential of Hydrogen (pH) -impedance and Endoscopy (Assessed at 1 and 3 months) Change in barium column height on timed barium Esophagogram (Assessed at pre procedure at 1 and 3 months).
LES pressure reduction	1 and 3 months	In both the arms reduction in mean LES pressure will be compared at 1 and 3 months
Change in barium column height on barium esophagogram	1 and 3 months	In both the groups time barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes.
Comparison of changes in Eckardt score	1, 3 and 12 months	In both the groups Eckardt score ( based on symptoms of Dysphagia, Chest pain, regurgitation and weight loss) will be compared

Trial Locations

Locations (1)

Mohan Ramchandani; 🇮🇳 Hyderabad, Telangana, India