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CTRI Number  CTRI/2024/07/071519 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Placement of the AXIOS stent to manage symptoms of Gastric Outlet Obstruction. 
Scientific Title of Study   A Prospective Multi-Center Single Arm Study of Endoscopic Ultrasound Guided Gastroenterostomy with Lumen Apposing Metal Stent for Gastric Outlet Obstruction from Malignant Unresectable Disease  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
96996418  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sundeep Lakhtakia 
Designation  Assistant Professor 
Affiliation  Asian Institute of Gastroenterology 
Address  1 66 AIG 2 to 5 Mindspace Rd P Janardhan Reddy Nagar Gachibowli

Hyderabad
TELANGANA
500032
India 
Phone  9182645727  
Fax    
Email  drsundeeplakhtakia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sundeep Lakhtakia 
Designation  Assistant Professor 
Affiliation  Asian Institute of Gastroenterology 
Address  1 66 AIG 2 to 5 Mindspace Rd P Janardhan Reddy Nagar Gachibowli

Hyderabad
TELANGANA
500032
India 
Phone  9182645727  
Fax    
Email  drsundeeplakhtakia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sundeep Lakhtakia 
Designation  Assistant Professor 
Affiliation  Asian Institute of Gastroenterology 
Address  1 66 AIG 2 to 5 Mindspace Rd P Janardhan Reddy Nagar Gachibowli

Hyderabad
TELANGANA
500032
India 
Phone  9182645727  
Fax    
Email  drsundeeplakhtakia@gmail.com  
 
Source of Monetary or Material Support  
Boston Scientific 300 Boston Scientific Way Marlborough, MA 01752-1234 USA 
 
Primary Sponsor  
Name  Boston Scientific Corporation 
Address  300 Boston Scientific Way Marlborough, MA 01752-1234 USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Boston Scientific   300 Boston Scientific Way Marlborough, MA 01752-1234 USA 
 
Countries of Recruitment     Belgium
Brazil
Canada
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 Sundeep Lakhtakia  Asian Institute of Gastroenterology   1-66/AIG/2 to 5, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad Telangana, India 500032
Hyderabad
TELANGANA 		 9182645727

drsundeeplakhtakia@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Asian Institute of Gastroenterology  Approved 
Asian Institute of Gastroenterology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K315||Obstruction of duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endoscopic Ultrasound Guided Gastroenterostomy EUS-GE   EUS-guided gastroenterostomy EUS GE using the AXIOSTM lumen apposing Metal Stent also known as LAMS for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm. This allows the passage of food due to its larger diameter and avoid the risk of tumor ingrowth as the placement of the stent is outside the location of obstruction. This could result in a faster resolution of GOO symptoms with fewer reinterventions. 
Comparator Agent  Surgical Gastrojejunostomy or placement of a Self-Expanding Metal Stent (SEMS).   Surgical Gastrojejunostomy is an Invasive treatment that changes the anatomy to restore oral intake. Placement of a Self-Expanding Metal stent is a less invasive than a surgical gastrojejunostomy and opens the obstructed site to allow treatment for GOO symptoms. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Gastric outlet obstruction from unresectable malignant neoplasm

Eligible for endoscopic intervention

GOOS of 0 or 1
0 no oral intake
1 liquids only
2 soft solids only
3 low-residue or full diet

18 years of age or older

Willing and able to comply with the study procedures or legally authorized representative LAR must provide written informed consent form ICF to participate in the study

The distance between the gastric lumen and jejunal lumen must be no more than 1 cm
 
 
ExclusionCriteria 
Details  Patients with baseline ECOG greater than 2 and or Karnofsky Performance score less than 30

Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent

Abnormal coagulation INR greater than 1.5 and not correctable per the discretion of the physician or who require continuous complete anticoagulation, and or any underlying condition associated with high risk of bleeding

Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage

Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography

Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1 cm at the proposed site of AXIOSTM stent insertion

Gastric varices located within a 2 cm radius of the device insertion location on the gastric wall

Ascites Grade greater than or equal to 2 confirmed by cross-sectional imaging

Vessels located within a 2 cm radius of the device insertion location

History of multiple abdominal surgeries and/or evidence of small bowel adhesions

Allergic to any of the device materials

Contraindications to use of electrical devices

Pregnancy

Prisoners and other vulnerable populations

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
AXIOS stent related or AXIOS endoscopic and/or study procedure related Serios Adverse Events through 30 days post stent placement  At the time of the stent placement through study completion, an average of 1-year. 
 
Secondary Outcome  
Outcome  TimePoints 
Transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS stent lumen. Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement  During the Procedure 
Improvement of GOOS by 1 point from baseline to any point during 14 days after AXIOS stent placement & GOOS remaining at 1 or more without the need for reintervention due to loss of stent function at 30 days post index procedure or death whichever comes first.  Through 14 days after procedure 
Clinical success over time defined as improvement of GOOS by 1 point from baseline at any time during 14 days after AXIOS stent placement & GOOS remaining at 1 or more. This endpoint will be evaluated at 3 months, 6 months, & 12 months
A patient undergoing reintervention for GOO is considered a failure of clinical success 		 Through study completion, an average of 1 year 
Time to resumption of oral intake after stent placement.  Immediately after the procedure 
Time to start or resume chemotherapy after AXIOSTM stent placement (where applicable)  Immediately after the procedure 
Change in Quality-of-Life score (SF-12 questionnaire) from baseline to 30 days, 3 months, 6 months, & 12 months  through study completion, an average of 1 year 
Incidence of Device Deficiencies. Including but not limited to stent migration & misplacement, stent occlusion, leakage at site of stent placement  Immediately after the procedure 
Incidence of Reintervention for GOO. Need for repeat treatment for persistent or recurrent GOO symptoms  Immediately after the procedure 
 
Target Sample Size   Total Sample Size="59"
Sample Size from India="12" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Suspended 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

To investigate the safety and technical success of EUS-guided gastroenterostomy EUS-GE using the AXIOSTM lumen apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.  Gastric outlet obstruction is the mechanical impediment to gastric emptying, a complication seen frequently in patients with benign or malignant pancreatic or upper gastrointestinal tumors. The most common occurrence of GOO in malignant etiologies is seen in pancreatic malignancies, reported up to 15 to 20 percent, and is associated with significant morbidity and poor survival rates. Patients are often presented with nausea, vomiting, malnutrition, weight loss, and reduced quality of life. When the normal emptying of the stomach becomes mechanically impeded, palliation by the management of oral intake is most commonly treated through two treatment modalities the traditional gold standard of surgical bypass or the endoscopic placement of a duodenal Self-Expanding Metallic Stent.

 
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