CTRI Number |
CTRI/2020/07/026501 [Registered on: 10/07/2020] Trial Registered Prospectively |
Last Modified On: |
21/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
It is the study to compare non surgical treatment modality for gastroduodenal obstruction |
Scientific Title of Study
|
NOVEL NON SURGICAL TREATMENT MODALITY FOR GASTRODUODENAL OUTLET OBSTRUCTION - RANDOMIZED CONTROLLED TRIAL |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Gireesh kumar Dhaked |
Designation |
Senior Resident |
Affiliation |
SMS medical college, jaipur |
Address |
108, department of gastroenterology, SMS medical college, Jaipur
Jaipur RAJASTHAN 302004 India |
Phone |
9013952349 |
Fax |
|
Email |
dr.gireeshdhaked2210@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Prachis Ashdhir |
Designation |
Associate Professor |
Affiliation |
SMS medical college, jaipur |
Address |
108, department of gastroenterology, SMS medical college, Jaipu
Jaipur RAJASTHAN 302004 India |
Phone |
9829966420 |
Fax |
|
Email |
pa894@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Gireesh kumar Dhaked |
Designation |
Senior Resident |
Affiliation |
SMS medical college, jaipur |
Address |
108, Department Of Gastroenterology, SMS Medical college, Jaipur
Jaipur RAJASTHAN 302004 India |
Phone |
9013952349 |
Fax |
|
Email |
dr.gireeshdhaked2210@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
SMS Hospital and medical college |
Address |
108, Department Of Gastroenterology, SMS Medical COllege |
Type of Sponsor |
Government medical college |
|
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 |
Gireesh dhaked |
SMS medical college |
108, Department Of Gastroenterology, SMS Medical college,Jaipur 302004
Jaipur RAJASTHAN |
9013952349
dr.gireeshdhaked2210@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SMS Medical college |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Misoprostol (400 mg TDS) Plus Pantoprazole (40 mg BD |
misoprostol (400 mg TDS) plus pantoprazole 40 mg BD, Oral, For 14 Weeks with CRE dilatation |
Comparator Agent |
Pantoprazole 40 mg BD |
PPI( Pantoprazole 40 mg BD), Oral For 14 weeks with CRE dilatation |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
1- Patients aged more than 18 years
2- With benign gastroduodenal stricture related to NSAIDs, opiods, caustic and peptic |
|
ExclusionCriteria |
Details |
1- Previous poor compliance with pharmacologic treatment.
2- Refused to give consent for participation in study
3- Contraindication for misoprostol therapy
4- Patient with other causes of benign GOO such as chronic pancreatitis, Crohn’s and tuberculosis and fibrotic(healed) stricture will also excluded.
5- Patient who continue to take NSAIDs, opiods and smoke will also excluded.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1-Symptoms resolution ( heart burn, vomiting, abdomen pain and post prandial fullness)
2-Need for CRE dilatataion( number of CRE dilatation session)
3-Need for surgery |
14 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improvement in nutritional status (Hemoglobin, serum albumin, bodyweight |
14 weeks |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
10/07/2020 |
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="3" Days="15" |
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
|
Gastric outlet obstruction (GOO) includes obstruction in the antropyloric area or in the bulbar or post bulbar duodenal segments. Though malignancy remains a common cause of GOO in adults, a significant number of patients with GOO have benign causes. Among the latter are peptic ulcer disease, caustic ingestion, post-operative anastomotic state, drugs induced and inflammatory causes such as Crohn’s disease and tuberculosis.
Current management of benign GOO begins with conservative measures such as IV PPIs, sucralfate, cessation of NSAIDs use, treatment of H. pylori when applicable, and gastric decompression. Recent research has shown the use of endoscopic balloon dilation and medical therapy to be associated with favorable long-term outcomes and is considered to be first-line treatment of benign GOO but one-third of patients may ultimately require surgical intervention. Still these strictures are difficult to manage conservatively and they usually require intervention to treat the stricture related complications. Although the surgical procedures are potentially curative, they are associated with high rates of morbidity and mortality. Several non-surgical, minimally invasive options are available to treat benign strictures of the gastric outlet. These procedures, which can be performed endoscopically or fluoroscopically, include balloon dilation, temporary stent placement, intralesional steroid injection and incisional therapy with proton pump inhibitor. There is high prevelence of recurrence after treatment with PPI and CRE dilatation with unsatisfactory results. Objective of the study- To assess the novel non surgical treatment modality for gastroduodenal ulcerative stricture
. Inclusion criteria -Patients aged more than 18 years, with benign gastroduodenal stricture related to NSAIDs, opiods, caustic and peptic.
Study methodology - Patients of benign ulcerated gastrotroduodenal stricture will be randomized (1:1) to PPI( Pantoprazole 40 mg BD) with CRE dilatation and misoprostol (400 mg TDS) plus pantoprazole 40 mg BD with CRE dilatation for 14 weeks. Outcome - Symptoms resolution ( heart burn, vomiting, abdomen pain and post prandial fullness), Need for CRE dilatataion( number of CRE dilatation session), Need for surgery, Improvement in nutritional status.
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