| CTRI Number |
CTRI/2017/07/008956 [Registered on: 03/07/2017] Trial Registered Prospectively |
| Last Modified On: |
03/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Endoscopy guided pancreatic fluid drainage and pancreatic duct stenting for pancreatic fluid collections |
|
Scientific Title of Study
|
EUS Guided Pseudocyst drainage: Prospective evaluation of short term placement of fully covered self expanding metal stents followed by pancreatic ductal stenting (The BIDS Protocol)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Dhir |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02267670308 |
| Fax |
|
| Email |
vinaydhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Dhir |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02267670308 |
| Fax |
|
| Email |
vinaydhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Dhir |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02267670308 |
| Fax |
|
| Email |
vinaydhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Endoscopy Research foundation, 3rd floor,Global Hospital, Ernest Borges Road, Mumbai, 12 |
|
|
Primary Sponsor
|
| Name |
Endoscopy Research foundation |
| Address |
3rd floor, Global Hospital , Mumbai, 400012 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vinay Dhir |
Global Hospital |
Room 301/302, Department of Gastroenterology.
Mumbai (Suburban)
MAHARASHTRA |
9819920266
vinaydhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Global Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pancreatic Pseudocyst, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NAGI FULLY COVERED STENT - TAEWOONG MEDICAL |
This is a fully covered stent which has been specially designed for pseudocyst drainage and has been licensed in India. Safe, efficacious and proven in various articles published internationally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Symptomatic pancreatic fluid collection.
|
|
| ExclusionCriteria |
| Details |
1) Pancreatic fluid collection > 1 cm away from stomach wall
2) Previous history of ERP and PD stenting.
3) Patients for whom endoscopic techniques are contraindicated
4) Participation in another investigational trial within 180 days
5) Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the safety and efficacy of short duration FCSEMS placement for symptomatic pancreatic fliud collection.
2. For formation of algorithm for management pancreatic fluid collection.
|
3 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the technical & clinical success and immediate complications of pancreatic fluid collection drainage by FCSEMS. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
10/07/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This was a single-center prospective evaluation. All patients with symptomatic pancreatic fluid collection with a well-defined wall will be included in the study for placement of SEMS into the pancreatic pseudocyst followed by pancreatic ductal stenting via ERCP if MRCP demonstrates pancreatic ductal leak.The patient will be kept under observation for 72 hours. Oral liquids will be allowed after 4 hours if the patient was asymptomatic. Intravenous antibiotics will be continued for 72 hours. Ultrasound for assessment will be done at 24 hr followed by Gastroscopy after 72 hours for necrosectomy. Cyst cavity will be cleaned of any debris by lavage (100 ml normal saline, 10 ml Hydrogen peroxide 6% and povidone-iodine 10% w/v), necrosectomy and suction if debris is present. Follow-up: Patients will be followed-up at 3 monthly intervals with clinical examination and abdominal ultrasonography for one year.
Definitions Technical success will defined as successful stent placement. Functional success will be defined as a residual cyst size of <2 cm on abdominal USG 24 hours after the procedure. The Lexicon criteria7 will be used to grade the adverse events. Recurrence will be defined as symptomatic recurrent fluid collection after complete resolution, in the same location as prior pseudocyst on follow-up abdominal ultrasonography. |