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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03186248
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Mohan Ramchandani, 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.

Condition or disease Intervention/treatment Phase
Achalasia Cardia Procedure: Per oral endoscopic myotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized clinical trial
Masking: Double (Participant, Investigator)
Masking Description: Double blind randomized clinical trial
Primary Purpose: Other
Official Title: Comparison of Short Versus Long Oesophageal Myotomy in Cases With Idiopathic Achalasia: A Randomized Single Blinded Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short myotomy
Per oral endoscopic myotomy extending from 3 cm cephalad to 3 cm distal to EGJ
Procedure: 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.

Active Comparator: Long myotomy
Per oral endoscopic myotomy extending from 6-8cm cephalad to and 3 cm distal to EGJ.
Procedure: 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.




Primary Outcome Measures :
  1. Comparison of clinical efficacy between short and long myotomy groups [ Time Frame: 1 year ]
    Clinical success defined as Eckardt score≤3 compared between the two groups


Secondary Outcome Measures :
  1. Difference in operating time between short and long esophageal myotomy during POEM [ Time Frame: 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

  2. Intraoperative adverse events [ Time Frame: 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).

  3. LES pressure reduction [ Time Frame: 1 and 3 months ]
    In both the arms reduction in mean LES pressure will be compared at 1 and 3 months

  4. Comparison of changes in Eckardt score [ Time Frame: 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

  5. Comparison of gastroesophageal Reflux disease (GERD) Rates [ Time Frame: 3 months ]
    Both the groups will under go clinical evaluation, esophagograstroscopy and ph metry

  6. Change in barium column height on barium esophagogram [ Time Frame: 1 and 3 months ]
    In both the groups time barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186248


Locations
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India
Mohan Ramchandani
Hyderabad, Telangana, India, 500082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Principal Investigator: mahiboob sayyed, MD Asian Institute of gastroenterology
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Responsible Party: Mohan Ramchandani, Principal investigator, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT03186248    
Other Study ID Numbers: AIG- 09/05
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohan Ramchandani, Asian Institute of Gastroenterology, India:
Achalasia cardia
myotomy
Per oral endoscopic myotomy
laparoscopic fundoplication
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases