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CTRI Number  CTRI/2022/11/047173 [Registered on: 10/11/2022] Trial Registered Prospectively
Last Modified On: 03/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to compare the safety and efficacy of surgical bypass versus endoscopic bypass for patients having gastric outflow block due to malignancy 
Scientific Title of Study   Endoscopic ultrasound guided gastrojejunostomy versus laparoscopic gastrojejunostomy for palliative management of malignant gastric outlet obstruction: a 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  Jayanta Samanta 
Designation  Associate Professor  
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Room 20, Nehru Hospital, F Block Department of Gastroenterology, PGIMER, Chandigarh Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  09855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Jayanta Samanta 
Designation  Associate Professor  
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Room 20, Nehru Hospital, F Block Department of Gastroenterology, PGIMER, Chandigarh Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  09855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Jayanta Samanta 
Designation  Associate Professor  
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Room 20, Nehru Hospital, F Block Department of Gastroenterology, PGIMER, Chandigarh Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  09855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Gastroenterology, PGIMER, Chandigarh. Sector-12, Chandigarh 
 
Primary Sponsor  
Name  Dr Jayanta Samanta 
Address  Department of Gastroenterology, PGIMER, Chandigarh 
Type of Sponsor  Other [Self] 
 
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 
Jayanta Samanta  Post Graduate Institute of Medical Education and Research, Chandigarh, India  Department of Gastroenterology, PGIMER, Chandigarh Sector -12 Chandigarh - 160012
Chandigarh
CHANDIGARH 		 9855319529

dj_samanta@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EUS Guided Gastrojejunostomy  EUS guided gastrojejunostomy will be done by the standard water-immersion technique. Fluid would be infused through the nasojejunal tube placed endoscopically and the jejunal loops will be inflated. Using a cautery mounted lumen apposing metal stent, GJ will be completed under EUS and fluoroscopic guidance. After the procedure, the patients would be followed up at the various time points of 3 days, 1 and 3 months for the assessment of the various outcomes.  
Comparator Agent  Surgical gastrojejunostomy  Surgical GJ would be performed using the standard laparoscopic gastrojejunostomy technique under general/spinal anesthesia. After the procedure, the patients would be followed up at the various time points of 3 days, 1 and 3 months for the assessment of the various outcomes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients ≥ 18 years of age with malignant symptomatic gastric outlet obstruction (GOO) requiring intervention with an unresectable malignant lesion (biopsy proven) or borderline/ locally advanced planned for neo-adjuvant therapy prior to surgery.
2. GOO confirmed endoscopically or radiologically.
3. GOOS (gastric outlet obstruction score) 0 (no oral intake) or 1 (only liquids).
4. The patient who gives informed consent for participation in the study.
 
 
ExclusionCriteria 
Details  1. Lack of informed consent
2. Pregnancy
3. Coagulation disorder (INR >1.5 or platelet count <50000/ul)
4. Multiple level bowel obstruction confirmed radiologically (contrast study or computed tomography scans)
5. Prior endoscopic or surgical treatment for GOO.
6. Severe comorbidities precluding endoscopic treatment (cardiorespiratory instability, severe pulmonary disease, bleeding disorder)
7. Previous gastric, periampullary or duodenal surgery
8. Complete GOO evidenced by inability to either pass a wire/nasojejunal tube across the stricture and/or inability to opacify small bowel distal to the malignant stricture
9. Malignant conditions involving the stomach such as Linitis plastica, malignancy of the proximal stomach etc.
10. Life expectancy of less than 1 month
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Adverse events between EUS-GJ versus surgical GJ for management of malignant GOO.  At 3 days and 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
1. Technical success
2. Clinical success
3. Time taken for the procedure
4. GOOS (gastric outlet obstruction score)
5. Time to initiate of oral diet
6. Time to full oral diet (GOOS 3) starting from the day of the procedure
7. Quality of life assessment scores [EORTC QLQ-C30, SF-36 module] at baseline, 1 and 3 months
8. Patency of gastro-jejunal anastomosis at 1 and 3 months
9. Duration of gastro-jejunal patency
10. Reintervention rates for recurrent GOO at 1, and 3 months
11. Dysfunction rates at 1, and 3 months
12. Overall survival rates
13. Rate of recurrent GOO visualised endoscopically/radiologically at 1, and 3 months
14. Time to recurrent GOO
15. Mortality (due to any cause)
 		 3 days, 1 mon, 3 months
 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   Phase 3 
Date of First Enrollment (India)   14/11/2022 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dj_samanta@yahoo.co.in].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 31-12-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Endoscopic ultrasound guided gastrojejunostomy (EUS-GJ) using lumen apposing metal stent  (LAMS) is a relatively newer modality for palliation of malignant GOO. It is minimally invasive, provides rapid relief of symptoms, with long term patency of the anastomosis created (leading to lower reinterventions), it has gained widespread recognition as a first line choice for GOO. Few multicentre studies exist comparing EUS-GJ with surgical GJ. EUS-GJ has been shown to have performed as well as a surgical GJ with lower adverse event rates and shorter recovery time. But there are no prospective randomised controlled studies for the same. Hence this study has been designed as an open-label randomized controlled trial (RCT) to compare EUS-GJ with laparoscopic GJ for  malignant GOO.

 
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