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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis Necrotizing
• Intervention / Treatment: Device: Transmural Plastic stenting

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500082
      • Asian Institute of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transmural stenting; 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; 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.
No Intervention: No stenting; In patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks without any further intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of PFC	In the study will see the re-ccurence of fluid collection in control and study arm	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 Months

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 10, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Walled of necrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pancreatic Diseases; Recurrence; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: AIG-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No