Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Disconnected Pancreatic Duct
Condition: Acute Pancreatitis Necrotizing
MeSH terms: Pancreatitis; Pancreatitis, Acute Necrotizing; Recurrence
Study type: Interventional

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.
    

Intervention name(s): Transmural Plastic stenting
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Walled of necrosis