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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  
SMS medical college 
 
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  
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 
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  
Status 
Not Applicable 
 
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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