| CTRI Number |
CTRI/2024/05/066804 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Endoscopic ultrasound guided] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EUS-Guided vs. Surgical Gastrojejunostomy for Gastric Outlet Obstruction |
|
Scientific Title of Study
|
Randomized trial comparing endoscopic ultrasound-guided gastrojejunostomy and surgical gastrojejunostomy in gastric outlet obstruction. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Puri |
| Designation |
Vice Chairman Interventional Gastroenterology Medanta Institute of Dig & Hepato Sciences |
| Affiliation |
Medanta The Medicity |
| Address |
11th Floor Gastro Department Medanta The Medicity Sector 38 Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
9999411125 |
| Fax |
|
| Email |
purirajesh1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Puri |
| Designation |
Vice Chairman Interventional Gastroenterology Medanta Institute of Dig & Hepato Sciences |
| Affiliation |
Medanta The Medicity |
| Address |
11th Floor Gastro Department Medanta The Medicity Sector 38 Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
9999411125 |
| Fax |
|
| Email |
purirajesh1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bimal Kumar Sahu |
| Designation |
Consultant Gastroenterology Medanta Institute of Dig & Hepato Sciences |
| Affiliation |
Medanta The Medicity |
| Address |
11th Floor Gastro Department Medanta The Medicity Sector 38 Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
7982076322 |
| Fax |
|
| Email |
bimal.sahu@medanta.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ji Young Bang |
| Address |
Orlando, Florida, United States,32806 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Germany
India
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Puri |
Medanta |
Room number 5, Institute of Digestive & Hepatobiliary Sciences
Gurgaon
HARYANA |
9999411125
purirajesh1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K315||Obstruction of duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EUS-guided gastrojejunostomy |
AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.
Duration of procedure: 20-30 minutes. |
| Comparator Agent |
Surgical gastrojejunostomy |
A surgical gastrojejunostomy will be created via laparoscopic (preferred) or open technique, as clinically appropriate.
Duration of procedure: 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥ 18 years
2. Presence of gastric outlet obstruction on any imaging or endoscopy from known
or suspected malignancy
3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as
maximum oral intake of liquids only)
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Intrauterine pregnancy
Use of anticoagulants that cannot be discontinued for the procedure
Unable to obtain consent for the procedure from either the patient or LAR |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients unable to tolerate a solid diet (defined as gastric outlet obstruction scoring system)
and overall rate of adverse event |
1. Pre index procedure
2. Post index procedure
3. Day of Discharge
4. 1 month post index procedure
5. 3 month post index procedure
6. 6 month post index procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN). |
At 1-month post-procedure |
| Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 3-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN). |
At 3-month post-procedure |
| Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN). |
At 6-month post-procedure |
| Rate of technical success |
24 hours |
| Procedure duration |
24 hours |
| Time to diet advancement |
During 1 month |
| Time to recurrence of obstructive symptoms |
After achieving GOOSS ≥ 2 for at least 7 days at any time during follow-up. |
| Rate of persistence of symptoms |
Up to 2 weeks after index procedure. |
| Rate of reintervention |
During 6 months after Index procedure |
| Total number of readmissions |
During 6 months after Index procedure |
| Rate of adverse events due to procedures performed |
From index procedure to upto 6 months |
| Rate of adverse events due to underlying disease |
From index procedure to upto 6 months |
| Total length of hospital stay |
From the date of the procedure to the date of discharge. |
| Length of survival |
post-procedure. |
| Quality of life measurement |
At baseline, discharge, 1 months and 6 months post procedure. |
| Overall treatment costs from index procedure until 6 months post-index procedure. |
At 6 months post procedure |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="10"
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)
|
13/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction. |