| CTRI Number |
CTRI/2017/07/009181 [Registered on: 31/07/2017] Trial Registered Prospectively |
| Last Modified On: |
27/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To perform a shorter dissection vs. longer during endoscopic surgery for achalasia cardia |
|
Scientific Title of Study
|
A prospective comparative evaluation of short length myotomy versus standard normal myotomy in patients undergoing per oral endoscopic myotomy for achalasia cardia type 1
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Maydeo |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 302, Department of Gastroenterology, Baldota Institute of digestive sciences, Global Hospital, Ernest Borges road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022267670312 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Maydeo |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 302, Department of Gastroenterology, Baldota Institute of digestive sciences, Global Hospital, Ernest Borges road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022267670312 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Maydeo |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 302, Department of Gastroenterology, Baldota Institute of digestive sciences, Global Hospital, Ernest Borges road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022267670312 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Endoscopy Research foundation, 3rd floor, Global hospital, Ernest Borges road, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Endoscopy Research foundation |
| Address |
Baldota Institute of digestive sciences, Global Hospital, Ernest Borges road, Parel, Mumbai |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amit Maydeo |
Global Hospital |
Room 302, Department of Gastroenterology, Ernest Borges road, Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
022267670312
amitmaydeo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Global Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Achalasia cardia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Short myotomy |
Instead of a long 8-10 cm esophageal myotomy a shorter 4-5 cm myotomy would be performed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients with type 1 achalasia cardia |
|
| ExclusionCriteria |
| Details |
1>Patients who are below 18 years age
2>Patients who are pregnant or breast feeding
3>Patients who are unable to give consent
4>Patients with indeterminate type of achalasia or patients not fit for general anaesthesia.
5>Patients with advanced sigmoid type 2 oesophagus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is symptom resolution with Eckardt score normalizing to 3/12 with basal LES pressures below 20 mm of mercury and IRP values 15 mm of mercury.
|
This will be assessed at week 4, 12 and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1Technical success- This is defined as an adequate length myotomy on the oesophageal and gastric side has been achieved
2Treatment success- Relief from the symptoms of achalasia with the Eckardt score normalizing, IRP and basal LES pressures normalizing on HRM
3Technical failure- Failure to form a sub mucosal tunnel and adequate myotomy
4Procedural duration – Time taken for a short myotomy
5Length of hospital stay for any complications
6HRM and OGD findings on Month 1, 12
|
Month 1, 12 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Per-oral endoscopic myotomy (POEM) was developed from this technique and
features the creation of a submucosal tunnel enabling the LES myotomy to be
performed away from the mucosal entry site which is closed at the end of the
procedure.
This is an internationally well recognised and established procedure to treat patients with achalasia cardia.
we only seek to modify the procedure which will reduce operative time and complications.
As the patients in type 1 achalasia have no peristalsis and no motility
in the oesophagus a longer length myotomy often does not add any extra
therapeutic benefit to the patient.
As such there is no difference in the procedure hence the adverse events
are comparable in both groups of patients. |