Clinical trial · Interventional
Clinical Evaluation of Enteral-extended Anti-reflux Stents for Pancreatic Pseudocyst
- 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)
At present, endoscopic therapy is the preferred method to solve biliary or pancreatic diseases. And EUS-guided stent implantation and drainage of pancreatic pseudocyst is the main method in Endoscopic treatment of pancreatic pseudocyst. However, blockage of stent is a problem that has puzzled endoscopists for a long time. The mechanism of stent blockage is related to the reflux of gastrointestinal contents into the stent. Although plastic stents are widely used in patients who needed drainage. However, the average free time for stent is only 77 to 126 days, leading to the need for stent replacement in most patients within 3 months. As one end of the double pigtail stent used for drainage of pancreatic pseudocyst may be located in the stomach, it may cause the stent to be blocked by the contents of the stomach. Therefore, multiple stents or additional stents or drainage tube are often needed to further strengthen the drainage. It seems that the mechanism of stent blockage are associated with gastrointestinal contents reflux. And stents required be replaced again by endoscopic approach when jamming. However, EUS and ERCP are difficult, costly, and may be with complications. Additional operations will increase the risks and costs. Therefore, a stent that can effectively prevent reflux, solve clinical problems, and effectively prolong stent patency time is urgently needed.
Conditions
Conditions (1)
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 Pseudocyst | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plant enteral-extended anti-reflux stents | Combination Product | — | UNRESOLVED |
| Plant traditional stents | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enteral-extended Anti-reflux Stents Group
- description
- Patients are going to implant enteral-extended anti-reflux stents
- interventionNames
- Combination Product: Plant enteral-extended anti-reflux stents
- type
- ACTIVE_COMPARATOR
- label
- Traditional Stents Group
- description
- Patients are going to implant traditional stents
- interventionNames
- Combination Product: Plant traditional stents
Primary outcomes (1)
- measure
- Disappearance rate of pseudocyst（PDR） after stent implantation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Pancreatic pseudocyst by a variety of causes, including acute pancreatitis, chronic pancreatitis, drug-induced pancreatitis * Pseudocyst compressed gastrointestinal or bile duct and causes obstruction symptoms or causes other symptoms * Diameter of pseudocyst \>6 cm with no compression symptoms, but progressively increases and is failed to conservatively treat Exclusion Criteria: * Wall-off necrosis with liquidation mimics pseudocyst * Pseudocyst formation ≤8 weeks, cyst wall is immature * Cannot puncture by EUS-guided approach for any reason * Patients with serious cardiovascular or cerebrovascular diseases or other diseases which are not fitted to anaesthetize * Severe coagulopathy or thrombocytopenia
References
Publications (6)
- BACKGROUNDReddy DN, Banerjee R, Choung OW. Antireflux biliary stents: are they the solution to stent occlusions? Curr Gastroenterol Rep. 2006 Apr;8(2):156-60. doi: 10.1007/s11894-006-0012-x. PMID 16533479
- BACKGROUNDPedersen FM, Lassen AT, Schaffalitzky de Muckadell OB. Randomized trial of stent placed above and across the sphincter of Oddi in malignant bile duct obstruction. Gastrointest Endosc. 1998 Dec;48(6):574-9. doi: 10.1016/s0016-5107(98)70038-0. PMID 9852446
- BACKGROUNDvan Berkel AM, Boland C, Redekop WK, Bergman JJ, Groen AK, Tytgat GN, Huibregtse K. A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction. Endoscopy. 1998 Oct;30(8):681-6. doi: 10.1055/s-2007-1001388. PMID 9865556
- BACKGROUNDWalter D, Will U, Sanchez-Yague A, Brenke D, Hampe J, Wollny H, Lopez-Jamar JM, Jechart G, Vilmann P, Gornals JB, Ullrich S, Fahndrich M, de Tejada AH, Junquera F, Gonzalez-Huix F, Siersema PD, Vleggaar FP. A novel lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections: a prospective cohort study. Endoscopy. 2015 Jan;47(1):63-7. doi: 10.1055/s-0034-1378113. Epub 2014 Sep 30. PMID 25268308
- BACKGROUNDAburajab M, Smith Z, Khan A, Dua K. Safety and efficacy of lumen-apposing metal stents with and without simultaneous double-pigtail plastic stents for draining pancreatic pseudocyst. Gastrointest Endosc. 2018 May;87(5):1248-1255. doi: 10.1016/j.gie.2017.11.033. Epub 2017 Dec 9. PMID 29233670
- BACKGROUNDBrimhall B, Han S, Tatman PD, Clark TJ, Wani S, Brauer B, Edmundowicz S, Wagh MS, Attwell A, Hammad H, Shah RJ. Increased Incidence of Pseudoaneurysm Bleeding With Lumen-Apposing Metal Stents Compared to Double-Pigtail Plastic Stents in Patients With Peripancreatic Fluid Collections. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1521-1528. doi: 10.1016/j.cgh.2018.02.021. Epub 2018 Feb 21. PMID 29474970