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CTRI Number  CTRI/2017/07/009182 [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   A study to assess a new endoscopy guided procedure to ameliorate acid reflux 
Scientific Title of Study   A prospective pilot study to assess safety and feasibility of anti reflux mucosectomy for gastroesophageal reflux disease 
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  Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Parel, Mumbai
Room 302, 3rd floor, Ernest Borges Road, Parel, Mumbai
Mumbai (Suburban)
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  Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Parel, Mumbai
Room 302, 3rd floor, Ernest Borges Road, Parel, Mumbai
Mumbai (Suburban)
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  Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Parel, Mumbai
Room 302, 3rd floor, Ernest Borges Road, Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  022267670312  
Fax    
Email  amitmaydeo@gmail.com  
 
Source of Monetary or Material Support  
Endoscopy research foundation, 3rd floor, Global Hospital, Mumbai , 400012 
 
Primary Sponsor  
Name  Endoscopy Research foundation 
Address  Global Hospital, Ernest Borges Road, Parel, Mumbai 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Gastro esophageal reflux disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anti reflux mucosectomy  Standard endoscopic mucosectomy techniques are followed to resect the mucosa of the fundus on the lesser curve 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients with gastroesophageal reflux disease 
 
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 hiatus hernia, patients not fit for general anaesthesia.

5>Patients with NERD, Hypersensitive oesophagus

6>Patients with oesophageal dysmotility

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To alleviate GERD symptoms without any adverse effects to the patient  week 4, 12 
 
Secondary Outcome  
Outcome  TimePoints 
Technical success- This is defined as an adequate mucosectomy on the oesophageal and gastric side has been achieved

Treatment success- Relief from the symptoms of GERD, stopping of PPI therapy with normalizing of 24 pH test.

Technical failure- Failure to perform a adequate mucosectomy

Procedural duration – Time taken for the mucosectomy

Length of hospital stay for any complications

24 hour pH and OGD findings on week 8.
 
week 4, 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   Inoue H, Takeshita K, Hori H, Muraoka Y, Yoneshima H, Endo M. Endoscopic mucosal resection with a cap-fitted panendoscope for esophagus, stomach, and colon mucosal lesions. Gastrointest Endosc.1993;39:58–62. [PubMed 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Crescentic ARMS of the esophagogastric junctional (EGJ) mucosa will be conducted with the now standardized techniques of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD), of at least 3 cm length (1 cm in the esophagus and 2 cm in the stomach), with the length of mucosal resection at the cardia measured in retroflexion from the gastric side. ARMS was conducted along the side of the lesser curve of the stomach, thus preserving a sharp mucosal valve at gastric cardia.

 Results suggest a potential anti-reflux effect of ARMS. The mechanism is presumed to be due to scar formation after healing of the mucosal defect . On the gastric side, this induces narrowing of the gastric cardia opening, while preserving and/or re-creating a robust his angle. We also postulate some remodeling of mucosal flap valve as an effective antireflux mechanism at this anatomical level.

As demonstrated in , after ARMS, the lesser curve of the gastric cardia takes on an almost “mechanically-stitched” appearance. The mucosal flap is rebuilt and looks well-defined. Furthermore, the lesser curve side of the EGJ is shortened with scar formation, and greater curve of EGJ (his angle side) is kept non-scarred and therefore retains its flexibility as a mucosal flap valve. Another major advantage of this procedure is that it requires no proprietary equipment and leaves no artificial prostheses in situ (which could generate a foreign body reaction in the future).

Although possible complications may include perforation or bleeding, the techniques of EMR/ESD used in this procedure have become standardized and popularized. These risks are likely to be minimal in “expert” hands and, even if experienced, can be resolved using standardized endoscopic recovery techniques such as coagulation forceps or clips for bleeding and perforation . Furthermore, piecemeal EMR could be a less time-consuming and acceptable (sole) technique in this procedure, particularly if the specimen involves no dysplasia.


 
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