| CTRI Number |
CTRI/2019/06/019819 [Registered on: 24/06/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Endoscopic Full Thickness Plication for esophageal abnormal acid exposure post Peroral endoscopic myotomy |
|
Scientific Title of Study
|
A randomised study comparing Endoscopic Full Thickness Plication (GERD-X) vs. Sham for esophageal abnormal acid exposure post Peroral endoscopic myotomy in patients with achalasia cardia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Patil |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 302, Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9650355454 |
| Fax |
|
| Email |
gauravkpatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Patil |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 302, Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9650355454 |
| Fax |
|
| Email |
gauravkpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Patil |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 302, Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9650355454 |
| Fax |
|
| Email |
gauravkpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Endoscopy Research Foundation, Om Chambers, 123 August Kranti Marg, Mumbai, Maharashtra 400036 |
|
|
Primary Sponsor
|
| Name |
Endoscopy Research Foundation |
| Address |
Om Chambers, August Kranti Marg, Mumbai 400036 |
| Type of Sponsor |
Other [Research Foundation] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Maydeo |
Baldota Institute of Digestive Sciences |
Room No 1, Chairmans Chamber, Baldota Institute of Digestive Sciences, 3rd floor, Global Hospitals, Parel
Mumbai
MAHARASHTRA |
02267670311
amitmaydeo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K220||Achalasia of cardia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GERD-X group |
Endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under anesthesia. Guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the GERD-X device. |
| Comparator Agent |
SHAM group |
In sham group, identical technique will be followed by positioning the plicator inside the stomach but sutures will not be applied. All procedures will be performed under anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged 18-70 years and above
2. Aachalasia cardia patients minimum 3 months post POEM with abnormal 24hr pH metry, regardless of symptoms
3. Abnormal esophageal acid exposure defined as percentage time esophageal pH less than 4 of more than 4.2% on pH-metry during 24-h period while off PPI for atleast 1 week
4. Patients agreeing to informed consent |
|
| ExclusionCriteria |
| Details |
1. Failed POEM – elevated integrated relaxation pressure and lower esophageal sphincter pressure
2. Hiatus hernia hills 3 or more
3. Patients with significant renal or liver disease
4. Grade D esophagitis
5. Barrett’s esophagus
6. ASA physical status >II
7. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of abnormal acid exposure by 24 hr ph study |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in GERD-Q |
1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/06/2019 |
| 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="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In patients who undergo POEM develop GERD who need to be managed with PPI. Of late trials have evaluated the efficacy of endoscopic plication technique for GERD and reported encouraging results. Endoscopic plication (GERD-X) is an alternative and less invasive procedure compared to laparoscopic fundoplication for the treatment of GERD. In endoscopic plication, transmural sutures are applied at the gastro-esophageal (GE) junction thereby reconstructing the gastric cardia and accentuating the valvular mechanism to prevent acid reflux. In this study we aim to evaluate the outcomes of GERD-X and compare it with Sham for esophageal abnormal acid exposure post Peroral endoscopic myotomy in patients with achalasia cardia in a randomized manner. |