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Clinical Evaluation of Enteral-extended Anti-reflux Stents for Pancreatic Pseudocyst

Primary Purpose

Pancreatic Pseudocyst

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Plant enteral-extended anti-reflux stents
Plant traditional stents
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Pseudocyst

Eligibility Criteria

12 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enteral-extended Anti-reflux Stents Group

Traditional Stents Group

Arm Description

Patients are going to implant enteral-extended anti-reflux stents

Patients are going to implant traditional stents

Outcomes

Primary Outcome Measures

Disappearance rate of pseudocyst(PDR) after stent implantation
PDR=1-(Postoperative pseudocyst area/Preoperative pseudocyst area)×100%

Secondary Outcome Measures

Time of disappearance of pseudocyst after stent implantation
Time of disappearance of pseudocyst after stent implantation

Full Information

First Posted
January 29, 2023
Last Updated
January 29, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05716594
Brief Title
Clinical Evaluation of Enteral-extended Anti-reflux Stents for Pancreatic Pseudocyst
Official Title
Clinical Evaluation of Enteral-extended Anti-reflux Stents for Pancreatic Pseudocyst
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. The extended enteral anti-reflux stent developed by our research team has potential advantages in prolonging the patency period of the stent and preventing secondary infection of pseudocysts. In this study, we aim to evaluate the effect of the stent on the drainage of pancreatic pseudocyst.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Pseudocyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enteral-extended Anti-reflux Stents Group
Arm Type
Experimental
Arm Description
Patients are going to implant enteral-extended anti-reflux stents
Arm Title
Traditional Stents Group
Arm Type
Active Comparator
Arm Description
Patients are going to implant traditional stents
Intervention Type
Combination Product
Intervention Name(s)
Plant enteral-extended anti-reflux stents
Intervention Description
Plant enteral-extended anti-reflux stents in EUS-guided drainage of pancreatic pseudocysts
Intervention Type
Combination Product
Intervention Name(s)
Plant traditional stents
Intervention Description
Plant traditional stents in EUS-guided drainage of pancreatic pseudocysts
Primary Outcome Measure Information:
Title
Disappearance rate of pseudocyst(PDR) after stent implantation
Description
PDR=1-(Postoperative pseudocyst area/Preoperative pseudocyst area)×100%
Time Frame
in 6 months
Secondary Outcome Measure Information:
Title
Time of disappearance of pseudocyst after stent implantation
Description
Time of disappearance of pseudocyst after stent implantation
Time Frame
in 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonghui Huang, archiater
Phone
13911765322
Email
chengzhuopku@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonghui Huang, archiater
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghui Huang, archiater
Phone
13911765322
Email
chengzhuopku@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16533479
Citation
Reddy 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.
Results Reference
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PubMed Identifier
9852446
Citation
Pedersen 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.
Results Reference
background
PubMed Identifier
9865556
Citation
van 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.
Results Reference
background
PubMed Identifier
25268308
Citation
Walter 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.
Results Reference
background
PubMed Identifier
29233670
Citation
Aburajab 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.
Results Reference
background
PubMed Identifier
29474970
Citation
Brimhall 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.
Results Reference
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Clinical Evaluation of Enteral-extended Anti-reflux Stents for Pancreatic Pseudocyst

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