| 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
|
|
|
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
|
|
|
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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