ENDOSCOPIC ULTRASONOGRAPHYBFMSPNCT05632900

COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS - A PROSPECTIVE RANDOMISED CONTROLLED STUDY.

A study testing Endoscopic ultrasound guided drainage of walled off pancreatic necrosis in people with ENDOSCOPIC ULTRASONOGRAPHY, run by Asian Institute of Gastroenterology, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management. But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration . Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: ENDOSCOPIC ULTRASONOGRAPHY
What is being tested?: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteIndia
Study dates: 17 Jul 2021to 20 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic Walled-off pancreatic necrosis (WON)
Eligible for EUS guided BFMS placement
Signed informed consent .
Age >18 Years

Who cannot join

Types of pancreatic collections other than WON .
Drainage with stents other than BFMS
Previous attempts at drainage of WON
Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.
Pregnancy
Not willing to give informed consent

Trial locations and contacts

1 site in 1 country.

India1 site

Dr Rajesh Gupta
Hyderabad, Telangana, 500082

Other trials in India

About this study

Official title: COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS

Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management.

But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration .

This study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not.

There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone.

one study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS .

But there has been no prospective RCT to assess the utility of DPS to date

Read the detailed description

Inclusion Criteria: -

Symptomatic Walled-off pancreatic necrosis (WON)
Eligible for EUS guided BFMS placement
Signed informed consent .
Age >18 Years

Exclusion Criteria: -

Types of pancreatic collections other than WON .
Drainage with stents other than BFMS
Previous attempts at drainage of WON
Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.
Pregnancy
Not willing to give informed consent

Conditions: ENDOSCOPIC ULTRASONOGRAPHY
Being tested: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endoscopic ultrasound guided drainage of walled off pancreatic necrosisProcedure or surgery
It is Therapeutic procedure to treat walled off pancreatic necrosis.

Study groups in NCT05632900
Study group	Role	What they receive
NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.	Experimental	Endoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long with co Axial double pig tail stent used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection. Receives: Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.	Active comparator	Endoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection. Receives: Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).
To monitor the adverse events like bleeding, stent clogging and stent migration.
Measured: 4 weeks

Secondary outcomes (3)

re-intervention rates
Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent
Measured: 4 weeks
Technical success rate
Deployment of Stent
Measured: 4 weeks
Clinical success rate
Resolution of symptoms Resolution of size of walled of necrosis
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 202120 Dec 2022

First posted1 Dec 2022
Study start17 Jul 2021
Primary completion22 Oct 2022
Study completion20 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ENDOSCOPIC ULTRASONOGRAPHYStudies of the same condition, open and under way.
More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05632900
Sponsor's protocol ID: BFMSP -001
Acronym: BFMSP
Status last verified: Feb 2023
First submitted: 21 Nov 2022
Last updated: 24 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ENDOSCOPIC ULTRASONOGRAPHY trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS
ClinicalTrials.gov ID: NCT05632900
Acronym / sponsor ID: BFMSP / BFMSP -001
Conditions: ENDOSCOPIC ULTRASONOGRAPHY
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
Study start: 17 Jul 2021 (actual)
Primary completion: 22 Oct 2022 (actual)
Study completion: 20 Dec 2022 (actual)
First posted: 1 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management.

But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration .

This study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not.

There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone.

one study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS .

But there has been no prospective RCT to assess the utility of DPS to date

Detailed description

Inclusion Criteria: -

Symptomatic Walled-off pancreatic necrosis (WON)
Eligible for EUS guided BFMS placement
Signed informed consent .
Age >18 Years

Exclusion Criteria: -

Types of pancreatic collections other than WON .
Drainage with stents other than BFMS
Previous attempts at drainage of WON
Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.
Pregnancy
Not willing to give informed consent

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.	Experimental	Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosisEndoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long with co Axial double pig tail stent used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection.
NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.	Active comparator	Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosisEndoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Symptomatic Walled-off pancreatic necrosis (WON)
Eligible for EUS guided BFMS placement
Signed informed consent .
Age >18 Years

Key exclusion criteria (6 listed)

Types of pancreatic collections other than WON .
Drainage with stents other than BFMS
Previous attempts at drainage of WON
Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endoscopic ultrasound guided drainage of walled off pancreatic necrosisIt is Therapeutic procedure to treat walled off pancreatic necrosis.	Procedure or surgery	NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN., NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.

Primary outcome

Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).
Time frame: 4 weeks
To monitor the adverse events like bleeding, stent clogging and stent migration.

3 secondary outcomes

re-intervention rates
Time frame: 4 weeks
Technical success rate
Time frame: 4 weeks
Clinical success rate
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Individual participant dataSharing planned: No

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Lung Cancer, Lung; Node
Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
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An Artificial Intelligence System for Multimodal, Multi-class Diagnosis of Pancreatic Cystic Lesions Based on Endoscopic Ultrasonography
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Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rajesh Dr Gupta, MBBS MD DM principal investigator

Asian Institute of Gastroenterology, India

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05632900.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.