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CTRI Number  CTRI/2024/09/073581 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Short and Long Fully Covered Self-Expanding Metal Stents for Pancreatic Duct Strictures in Patients with Chronic Pancreatitis 
Scientific Title of Study   E7179 Fully Covered Self-Expanding Metal Stents for Pancreatic Duct Strictures in Patients with Chronic Pancreatitis and Pain Reduction during Prior Single Pancreatic Plastic Stent Placement 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
92944787, Version A, 26Jun2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohan Ramchandani 
Designation  Professor 
Affiliation  Asian Institute of Gastroenterology 
Address  AIG Gachibowli Plot No 2,3,4,5, Survey No 136, 1, Mindspace Rd

Hyderabad
TELANGANA
500032
India 
Phone  914023378888  
Fax  0  
Email  ramchandanimohan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mohan Ramchandani 
Designation  Professor 
Affiliation  Asian Institute of Gastroenterology 
Address  AIG Gachibowli Plot No 2,3,4,5, Survey No 136, 1, Mindspace Rd

Hyderabad
TELANGANA
500032
India 
Phone  914023378888  
Fax  0  
Email  ramchandanimohan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mohan Ramchandani 
Designation  Professor 
Affiliation  Asian Institute of Gastroenterology 
Address  AIG Gachibowli Plot No 2,3,4,5, Survey No 136, 1, Mindspace Rd

Hyderabad
TELANGANA
500032
India 
Phone  914023378888  
Fax  0  
Email  ramchandanimohan@gmail.com  
 
Source of Monetary or Material Support  
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 USA 
 
Primary Sponsor  
Name  Boston Scientific 
Address  100 Boston Scientific Way Marlborough, MA 01752 USA 
Type of Sponsor  Other [Medical device industry-global] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Belgium  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohan Ramchandani  Asian Institute of Gastroenterology Gachibowli  Plot No 2,3,4,5, Survey No 136, 1, Mindspace Rd
Hyderabad
TELANGANA 		 919182645727

ramchandanimohan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K861||Other chronic pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fully covered self-expanding metal stent (FCSEMS)  The WallFlex Pancreatic FCSEMS consists of platinum-cored Nitinol wires wound together to form a cylinder, including a flare on the distal end to prevent migration into the pancreas and a straight, rounded, “soft” tip on the proximal end. The stent is available with outer diameters of 6mm or 8mm in the body and proximal end, and outer diameters of 9.3mm or 11.7mm, respectively, in the distal flare. The stent also features six different lengths, which are categorized into short lengths (i.e., 40mm, 50mm, 60mm) and long lengths (i.e., 80mm, 100mm, and 120mm). It is available fully covered with a Permalumeâ„¢ covering. The stent includes a retrieval loop at the distal end of the stent to aid in repositioning or removal during the initial stent placement procedure or for removal from the pancreatic duct following indwell. The integrated retrieval loop is formed from the stent mesh wires and may be grasped and pulled with rat-toothed forceps. This results in the collapse of the stent, allowing it to be removed. The long length WallFlex Pancreatic FCSEMS features three drainage channels that run the outer length of the stent body. The desired indication for use of the device is to facilitate drainage of the pancreatic duct to maintain pain reduction in patients with painful chronic pancreatitis and who experienced pain reduction upon pancreatic duct decompression using a single pancreatic plastic stent. Study devices are manufactured by Boston Scientific Corporation. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age 18 or older

2. Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study

3. Chronic pancreatitis-induced stricture of Cremer Type IV, namely distal dominant stricture with upstream ductal dilation prior to PPS placement

4. Minimum 5mm diameter of dilated duct immediately upstream of pancreatic duct stricture prior to PPS placement

5. Availability of narcotic dosage for at least one month prior to PPS placement

6. Prior clearance of pancreatic stones where needed
o If pancreatic duct stone clearance includes ESWL, then a single PPS may be placed immediately after the ESWL procedure at the discretion of the Investigator (e.g., if there is concern about fragments of stone sludge in the side branches of the pancreatic duct).
NOTE: Per exclusion criterion #10, the indwell duration of a single PPS or the cumulative duration of consecutive, single PPS immediately prior to FCSEMS placement may not exceed 90 days.
o If new pancreatic duct stones requiring ESWL have formed by the time of intended FCSEMS placement, then the patient will not receive the FCSEMS and be excluded from the study. Further treatment of the patient will be provided per standard of practice outside of the study.

7. History of documented pain relief during PPS indwell (assessed via Izbicki pain scale), defined as:
o Severity of pain prior to PPS placement: VAS pain score >20 (assessed via Izbicki pain scale)
o Frequency of pain prior to PPS placement: Several times a month or more frequently (assessed via Izbicki pain scale)
o Pain relief during PPS indwell: Primary endpoint pain score (i.e., mean of the scores of the severity and frequency sectors of the Izbicki pain scale) after PPS placement <10, or ˃10 but reduced by at least 50% compared to score prior to PPS placement

8. Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of FCSEMS placement as applicable 
 
ExclusionCriteria 
Details  1. Pancreatic or peri-ampullary cancer with or without pancreatic duct strictures caused by malignancy

2. Biliary strictures caused by chronic pancreatitis that are symptomatic and/or in need of therapeutic intervention

3. Perforated duct

4. Ansa pancreatica

5. Presence of pancreatic cysts suspected to be cystic tumor or requiring transmural drainage

6. Duodenal/groove pancreatitis

7. Autoimmune pancreatitis

8. Pancreatic duct stenoses not located in the head of the pancreas

9. Failed access during an attempted ERCP on a prior date at the investigational center

10. Duration of indwell of a single PPS or cumulative duration of consecutive single PPS immediately prior to FCSEMS placement exceeding 90 days

11. History of prior single PPS followed by a stent-free period shorter than 1 year before enrollment into the study

12. History of prior multiple side-by-side PPS up to one year prior to enrollment

13. Increase of average daily narcotic dose by ≥50% during single PPS indwell

14. History of prior pancreatic metal stent(s)

15. Reported recent history of acute relapsing pancreatitis in the absence of chronic pancreatitis

16. Patients for whom endoscopic techniques are contraindicated

17. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor

18. Inability or refusal to comply with the follow-up schedule, including patients living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome

19. Women who are, or plan to become, pregnant during the course of the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PRIMARY EFFECTIVENESS ENDPOINT
Maintenance of pain relief 6 months after study stent removal or observation of complete distal migration (CDM)

PRIMARY SAFETY ENDPOINT
Rate of related serious adverse events (SAEs) 		 Following the study device procedure, follow-up visits will occur at Month 1, Month 3, and Month 6. 
 
Secondary Outcome  
Outcome  TimePoints 
Stricture resolution  Time of study stent removal or observation of complete or partial study stent migration 
Stent functionality  Study stent placement until study stent removal or observation of complete or partial study stent migration 
Izbicki pain scale  Assessed at each study visit 
Average daily narcotic dose for the prior month  Assessed at each study visit 
Study stent placement success  Study stent placement 
Endoscopic study stent removal success  Study stent removal 
Device deficiencies  Study stent placement through end of study 
 
Target Sample Size   Total Sample Size="65"
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)   28/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="6"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This study is a global, prospective, single arm study. It will feature two subsequent enrollment cohorts:

     - Pilot cohort: Long lengths SEMS only, up to 12 patients at up to 3 investigational sites

     - Pivotal cohort: Short and long lengths SEMS, up to 53 patients at up to 10 investigational sites

The objective of this study is to prospectively document the performance of a fully covered self-expanding metal stent (FCSEMS) (“study stent”) for treatment of pancreatic duct (PD) strictures in patients with painful chronic pancreatitis (CP) and pain reduction during prior single pancreatic plastic stent (PPS) placement.

 
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