NCT03436043

Brief Summary

Walled of necrosis (WON) is severe local complication of acute necrotizing pancreatitis. Disconnected pancreatic duct syndrome(DPDS) is commonly seen (50-60%) after necrotizing pancreatitis and has long term implication like recurrent pancreatic fluid collections (PFC)\] requiring re-intervention. Incidence of recurrent PFC is more common in patients with DPDS (17-50%) compared to others. Studies has shown permanent in-dwelling transmural stent reduces recurrence of PFC (1.7% vs 17.4%, p\<0.001). Nowadays,WON is effectively managed with endoscopic step up approach (96%). Several studies showed dedicated self-expandable metal stent (SEMS) are effective compared to the plastic stents in management of WON with decreased need of re-intervention. However, SEMS cannot be kept for longer duration because of associated adverse events. So, experts recommend to remove SEMS within 4-6 weeks of placement. Considering this background, study is planned with aim to see the effect of transmural plastic stenting on recurrence of PFC after SEMS removal in walled off necrosis with DPDS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

June 30, 2021

Status Verified

February 1, 2018

Enrollment Period

2.4 years

First QC Date

February 10, 2018

Last Update Submit

June 28, 2021

Conditions

Acute Pancreatitis Necrotizing

Keywords

Walled of necrosis

Outcome Measures

Primary Outcomes (1)

  • Recurrence of PFC

    In the study will see the re-ccurence of fluid collection in control and study arm

    3 months

Secondary Outcomes (1)

  • Technical Success

    24 Months

Study Arms (2)

Transmural stenting

EXPERIMENTAL

In patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks followed by transmural plastic stenting in the residual cavity.

Device: Transmural Plastic stenting

No stenting

NO INTERVENTION

In patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks without any further intervention.

Interventions

Transmural Plastic stentingDEVICE

After metal stent removal in patients of disconnected pancreatic duct syndrome, transmural plastic- double pig tail stent will be placed into the residual necrotic cavity with the standard duodenoscope.

Transmural stenting

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patient who underwent EUS guided drainage with metal stent DPDS on MRCP \& ERCP

You may not qualify if:

  • Unwillingness to give written informed consent MRCP/ERCP-PD stricture ? (mimics DPD), leak Bleeding diathesis (Coagulopathy \& thrombocytopenia) chronic pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, 500082, India

Location

Related Publications (1)

  • Chavan R, Nabi Z, Lakhtakia S, Gupta R, Jahangeer B, Talukdar R, Singh AP, Karyampudi A, Yarlagadda R, Ramchandani M, Kalapala R, Jagtap N, Reddy M, Tandan M, Rao GV, Reddy ND. Impact of transmural plastic stent on recurrence of pancreatic fluid collection after metal stent removal in disconnected pancreatic duct: a randomized controlled trial. Endoscopy. 2022 Sep;54(9):861-868. doi: 10.1055/a-1747-3283. Epub 2022 Feb 18.

    PMID: 35180798DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gastroenterologist

Study Record Dates

First Submitted

February 10, 2018

First Posted

February 19, 2018

Study Start

October 20, 2017

Primary Completion

March 27, 2020

Study Completion

November 5, 2020

Last Updated

June 30, 2021

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)