An interventional study of Transmural Plastic stenting in Acute Pancreatitis Necrotizing, sponsored by Asian Institute of Gastroenterology, India. Completed at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Treatment
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.
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.
74 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.
This study's enrollment of 90 is above the median of 70 across 47 interventional studies indexed under Pancreatitis, Acute Necrotizing.
Browse Pancreatitis, Acute Necrotizing studies →Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
In patients of walled off necrosis with disconnected pancreatic duct syndrome, metal stent will be removed at 3-4 weeks without any further intervention.
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.
Recurrence of PFC
In the study will see the re-ccurence of fluid collection in control and study arm
Time frame: 3 months
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
Time frame: 24 Months
Plan to share: No
Ran from Oct 2017 to primary completion in Mar 2020, 29 months.
Of 20 interventional studies with no phase under Pancreatitis, Acute Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 36. This study's 29 months is close to that.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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