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Do plastic stents placed for necrotic collection due to pancreatitis need to be kept indefinitely if there is disruption in the pancreatic duct?

Does indefinite trans-mural plastic stent prevent recurrence of pancreatic fluid collection in patients with walled-off-necrosis with disconnected pancreatic duct syndrome ?: A Randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033700
Enrollment
40
Registered
2021-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified

Interventions

Intervention1: Stent removal group: In this arm, the plastic stents/ metal stent will be removed at 3-4 weeks, post resolution of the primary collection, without any further intervention. Control Inte

Sponsors

Department of Gastroenterology PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All cases who have undergone a EUS guided drainage of a WON and diagnosed with DPDS on ERCP and/or MRCP. 2.Patients who will give informed consent for participation in the study. 3.Age = 18 years

Exclusion criteria

Exclusion criteria: 1.Presence of bleeding diathesis (thrombocytopenia/coagulopathy) 2.Underlying pancreatic malignancy 3.Pregnant/lactating female 4.Lack of informed consent

Design outcomes

Primary

MeasureTime frame
1.Recurrence of pancreatic fluid collection. 2.Occurrence of new onset symptoms requiring intervention secondary to recurrence of pancreatic fluid collection (PFC) Timepoint: At 3, 6 and 12 months

Secondary

MeasureTime frame
1.Technical success of the procedure (replacing metal with plastic stent) at baseline. 2.Adverse events related to presence of underlying plastic stent (bleeding/migration/perforation/fistula) 3.New onset diabetes mellitus 4.Complications associated with the deployment of the plastic stent at baseline 5.Development of left sided portal hypertensionTimepoint: 1. At baseline: assess technical success of the procedure and complications related to deployment of plastic stent. 2. At 3, 6 and 12 months: adverse events related to presence of plastic stents, new onset diabetes mellitus, left sided portal hypertension

Countries

India

Contacts

Public ContactDr Jayanta Samanta

Post Graduate Institute of Medical Education and Research (P.G.I.M.E.R), Chandigarh

dj_samanta@yahoo.co.in9855319529

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026