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Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Disconnected Pancreatic Duct

Primary Purpose

Acute Pancreatitis Necrotizing

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Transmural Plastic stenting
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis Necrotizing focused on measuring Walled of necrosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Asian Institute of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transmural stenting

No stenting

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Technical Success
complication associated with deployment of transmural plastic, stent migration,recurrence of pancreatic fluid collection at 6 months and 1 year,new onset diabetes mellitus

Full Information

First Posted
February 10, 2018
Last Updated
June 28, 2021
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT03436043
Brief Title
Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Disconnected Pancreatic Duct
Official Title
Does Transmural Plastic Stenting Prevent the Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Walled Off Necrosis With Disconnected Pancreatic Duct Syndrome ? -Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Acute necrotizing pancreatitis (ANP) is lethal complication and account for 10-20% of total pancreatitis. Necrotic collection is seen in majority of ANP and >50% of necrotic collection transform into Walled of necrosis (WON). Management of WON is challenging and under progressive evolution. With the advent of "step up approach" WON is effectively managed with greater success. Various studies and meta-analysis proved the efficacy of dedicated self-expandable metal stents (SEMS) over plastic stent in WON management. Disconnected pancreatic duct syndrome (DPDS) is late complication of necrotizing pancreatitis and increasingly identified after necrosectomy. DPDS is defined as complete disruption of the main pancreatic duct, resulting in a variable portion of the upstream pancreatic gland becoming isolated from the main pancreatic duct downstream. Ductal disruption leads to accumulation of pancreatic juice forming pancreatic or peri-pancreatic fluid collection. Incidence of recurrence of PFC in DPD is ~ 50%. DPDS is a separate clinical entity which demands special strategic approach and requires frequent re-intervention (surgical/endoscopic). Treatment option for DPDS is controversial and not yet clearly defined. Studies have shown that long term transmural plastic stent placement can reduce the recurrence rate (Stent removed-17% vs stent left behind-1.7%). So, some experts recommend that transmural stents can be left in situ indefinitely to decrease recurrence of PFC. Nowadays, SEMS are widely used for management of WON. However, metal stents cannot be kept for longer period because of increasing adverse events associated with longer duration (impaction/burring of SEMS in gastric wall, bleeding). So, recommendation is to remove SEMS as early as possible (within 4-6 weeks of drainage). Considering this fact, study is planned to evaluate the effect of transmural plastic stenting on recurrence of PFC after SEMS removal in walled off necrosis with DPDS. This will be randomised control study in patients with WON with DPDS who underwent SEMS drainage. After removal of SEMS patients with documented DPDS (magnetic resonance pancreatography and endoscopic retrograde pancreatography) will be randomised into 2 arms. In study arm after SEMS removal transmural plastic stent will be placed in to the cavity and in control arm SEMS will be removed with no transmural stenting. Thereafter patients will be followed at 3 months,6 months and yearly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis Necrotizing
Keywords
Walled of necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single blind
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transmural stenting
Arm Type
Experimental
Arm Description
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.
Arm Title
No stenting
Arm Type
No Intervention
Arm Description
In patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks without any further intervention.
Intervention Type
Device
Intervention Name(s)
Transmural Plastic stenting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of PFC
Description
In the study will see the re-ccurence of fluid collection in control and study arm
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Technical Success
Description
complication associated with deployment of transmural plastic, stent migration,recurrence of pancreatic fluid collection at 6 months and 1 year,new onset diabetes mellitus
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All the patient who underwent EUS guided drainage with metal stent DPDS on MRCP & ERCP Exclusion Criteria: Unwillingness to give written informed consent MRCP/ERCP-PD stricture ? (mimics DPD), leak Bleeding diathesis (Coagulopathy & thrombocytopenia) chronic pancreatitis
Facility Information:
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35180798
Citation
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.
Results Reference
derived

Learn more about this trial

Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Disconnected Pancreatic Duct

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