Clinical trial · Interventional
The Role of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Pancreatic Fluid Collections.
The Assessment of Effectiveness and Safety of Double Pigtail Plastic Stents During Endoscopic Transmural Drainage of Post-inflammatory Pancreatic and Peripancreatic Fluid Collections With Use of Lumen-apposing Metal Stents (LAMS).
NCT06134024CI-TRIAL-00071483unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn about clinical usefulness of double pigtail plastic stents during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of lumen-apposing metal stents (LAMS). The main question it aims to answer is: Does introduction of double pigtail plastic stents through the LAMS increases efficacy and safety of endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections?
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Necrosis | — | UNRESOLVED | — |
| Pancreatic Pseudocyst | — | UNRESOLVED | — |
| Pancreatitis, Acute | — | UNRESOLVED | — |
| Pancreatitis, Acute Necrotizing | — | UNRESOLVED | — |
| Pancreatitis, Chronic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only | Procedure | — | UNRESOLVED |
| Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LAMS with Double Pigtail Plastic Stents
- description
- The group of participants with post-inflammatory pancreatic and peripancreatic fluid collections with double pigtail plastic stents introduced through the LAMS during endoscopic transmural drainage.
- interventionNames
- Procedure: Introduction of double pigtail plastic stents through the LAMS during endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections
- type
- ACTIVE_COMPARATOR
- label
- LAMS without Double Pigtail Plastic Stents
- description
- The group of participants with post-inflammatory pancreatic and peripancreatic fluid collections without double pigtail plastic stents introduced through the LAMS during endoscopic transmural drainage.
- interventionNames
- Procedure: Endoscopic transmural drainage of post-inflammatory pancreatic and peripancreatic fluid collections with use of LAMS only
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * participants of both sexes aged above 18 years * participants, who provided informed consent for such treatment * eligibility for transmural endoscopic drainage of post-inflammatory pancreatic and peripancreatic fluid collections procedure according to current medical knowledge based on evidence-based medicine. Exclusion Criteria: * pregnancy, breastfeeding, or intention to become pregnant during the study * contraindications to electrosurgical instruments * allergy to any of the materials used in the study * participants ineligible for endoscopic treatment * participants ineligible for general anesthesia
References
Publications (12)
- BACKGROUNDThoeni RF. The revised Atlanta classification of acute pancreatitis: its importance for the radiologist and its effect on treatment. Radiology. 2012 Mar;262(3):751-64. doi: 10.1148/radiol.11110947. PMID 22357880
- BACKGROUNDSarr MG. 2012 revision of the Atlanta classification of acute pancreatitis. Pol Arch Med Wewn. 2013;123(3):118-24. doi: 10.20452/pamw.1627. Epub 2013 Jan 25. PMID 23396317
- BACKGROUNDManrai M, Kochhar R, Gupta V, Yadav TD, Dhaka N, Kalra N, Sinha SK, Khandelwal N. Outcome of Acute Pancreatic and Peripancreatic Collections Occurring in Patients With Acute Pancreatitis. Ann Surg. 2018 Feb;267(2):357-363. doi: 10.1097/SLA.0000000000002065. PMID 27805963
- BACKGROUNDFreeman ML, Werner J, van Santvoort HC, Baron TH, Besselink MG, Windsor JA, Horvath KD, vanSonnenberg E, Bollen TL, Vege SS; International Multidisciplinary Panel of Speakers and Moderators. Interventions for necrotizing pancreatitis: summary of a multidisciplinary consensus conference. Pancreas. 2012 Nov;41(8):1176-94. doi: 10.1097/MPA.0b013e318269c660. PMID 23086243
- BACKGROUNDArvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyokeres T, Hritz I, Hucl T, Milashka M, Papanikolaou IS, Poley JW, Seewald S, Vanbiervliet G, van Lienden K, van Santvoort H, Voermans R, Delhaye M, van Hooft J. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018 May;50(5):524-546. doi: 10.1055/a-0588-5365. Epub 2018 Apr 9. PMID 29631305
- BACKGROUNDBaron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31. PMID 31479658