| CTRI Number |
CTRI/2024/11/077427 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the performance of two different metal stents used for endoscopic drainage of fluid collections that develops after acute pancreatitis |
|
Scientific Title of Study
|
Comparison of two different lumen-apposing metal stents for endoscopic ultrasound-guided drainage of pancreatic fluid collections: A randomized controlled trial |
| Trial Acronym |
Nil |
|
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 |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Gastroenterology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayanta Samanta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Gastroenterology, PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jayanta Samanta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Gastroenterology, PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh
Sector - 12,
Chandigarh - 160012 |
|
|
Primary Sponsor
|
| Name |
Jayanta Samanta |
| Address |
Room no 20, Level I, Block F
Nehru Hospital,
Department of Gastroenterology,
PGIMER, Chandigarh,
Sector - 12,
Chandigarh - 160012 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sundeep Lakhtakia |
Asian Institute of Gastroenterology |
Division of Interventional EUS, Department Of Gastroenterology,
AIG, Hyderabad
Mindspace Road, Gachibowli,
Hyderabad
Hyderabad
TELANGANA |
9848040629
drsundeeplakhtakia@gmail.com |
| Dr Jayanta Samanta |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Room No 20, Block F, Department of Gastroenterology, Nehru Hospital, PGIMER, Chandigarh
Sector-12
Chandigarh - 160012
Chandigarh
CHANDIGARH |
9855319529
dj_samanta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Asian Institute of Gastroenterology, Hyderabad |
Submittted/Under Review |
| Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EUS-guided drainage using Hot-AXIOS system |
After informed consent, EUS-guided drainage of WON will be carried out using a linear array echoendoscope either with or without fluoroscopy. Drainage of WON will be done using free-hand technique in most cases, unless the operator feels for wire-guided technique. The cysts will be punctured using the electrocautery enhanced Hot-AXIOS system and the stent will be deployed in the desired location, with distal flange in the cavity and proximal in the GI lumen.
The subsequent procedures such as need for DEN and removal of stents on follow-up will be done as per the clinical scenario and standard institute protocol. The follow-up will be for a period of 6 months for the same. |
| Intervention |
EUS-guided drainage using Hot-SPAXUS system |
After informed consent, EUS-guided drainage of WON will be carried out using a linear array echoendoscope either with or without fluoroscopy. Drainage of WON will be done using free-hand technique in most cases, unless the operator feels for wire-guided technique. The cysts will be punctured using the electrocautery enhanced Hot-SPAXUS system and the stent will be deployed in the desired location, with distal flange in the cavity and proximal in the GI lumen.
The subsequent procedures such as need for DEN and removal of stents on follow-up will be done as per the clinical scenario and standard institute protocol. The follow-up will be for a period of 6 months for the same. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of WON
Symptomatic patients with WON requiring drainage
Amenable for EUS-guided drainage
Informed consent |
|
| ExclusionCriteria |
| Details |
ANC less than 4 weeks
Pancreatic pseudocyst
Previous intervention or drainage
Asymptomatic collections
bleeding diathesis, uncorrectable coagulopathy or thrombocytopenia precluding drainage
underlying malignancy
pregnant female
|
|
|
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 |
| Number of patients who experienced overall bleeding events post index EUS-drainage of WON |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Overall adverse events post EUS-D
2. Technical success
3. Clinical success
4. Need for reintervention
5. Hospital stays, ICU stay, ventilatory stay (post index drainage procedure)
6. Mortality rates
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
01/01/2025 |
| 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="2"
Months="1"
Days="1" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dj_samanta@yahoo.co.in].
- For how long will this data be available start date provided 31-12-2027 and end date provided 31-12-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Endoscopic
ultrasound (EUS)-guided drainage represents the standard of care for the
treatment of symptomatic pancreatic fluid collections (PFCs), i.e., pseudocysts
(PC) and walled-off necrosis (WON).The introduction of
lumen apposing metal stents (LAMSs) has substantially increased the ability to
treat these collections, particularly necrotic collections. Indeed,
LAMSs allow quick drainage of large collections and the creation of a window
through which necrotic content can more easily be drained as compared to double
plastic pigtail stents or, when needed, direct endoscopic necrosectomy
(DEN) can be done. The two cautery enhanced LAMS currently available are the Hot-AXIOS and Hot-SPAXUS system. The
concern for bleeding-related AEs after AXIOS placement has been shown by recent data from post-marketing surveillance from the Food and Drug
Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE),
which highlighted the relatively high number of reports of EC-AXIOS-related
bleeding (32% cases). Recently,
a retrospective multi-centre propensity matched comparison of AXIOS vs SPAXUS
stents for treatment of PFCs has been published which revealed
SPAXUS stents to have a lower overall bleeding rates and
overall adverse events. Since
there is no head-to-head prospective comparison to address this gap, this
randomized-controlled trial (RCT) has been designed to compare the occurrence
of overall bleeding rates between the Hot-Axios and the Hot-Spaxus stent, in
patients with WON. In addition, the technical and clinical success and overall
adverse event rates of the two stents will be also analysed and compared. |