Clinical Evaluation of Enteral-extended Anti-reflux Stent... | NCT05716594

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

NCT05716594

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Feb 8, 2023Actual

Enrollment

52Estimated

Phase

Phase 2

Conditions

Pancreatic Pseudocyst

Interventions

Plant enteral-extended anti-reflux stents
Plant traditional stents

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Estimated

Primary Completion Date

Jul 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 29, 2023

First Submission Date that Met QC Criteria

Jan 29, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2023

Last Update Posted Date

Feb 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Huang Yonghui, Chief Physician, Peking University Third HospitalPrincipal Investigator

Lead Sponsor

Peking University Third HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enteral-extended Anti-reflux Stents Group	Experimental	Patients are going to implant enteral-extended anti-reflux stents	Combination Product: Plant enteral-extended anti-reflux stents
Traditional Stents Group	Active Comparator	Patients are going to implant traditional stents	Combination Product: Plant traditional stents

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plant enteral-extended anti-reflux stents	Combination Product	Plant enteral-extended anti-reflux stents in EUS-guided drainage of pancreatic pseudocysts	Enteral-extended Anti-reflux Stents Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disappearance rate of pseudocyst（PDR） after stent implantation	PDR=1-(Postoperative pseudocyst area/Preoperative pseudocyst area)×100%	in 6 months

Secondary Outcomes

Measure	Description	Time Frame
Time of disappearance of pseudocyst after stent implantation	Time of disappearance of pseudocyst after stent implantation	in 6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yonghui Huang, archiater	Contact	13911765322		chengzhuopku@163.com

Overall Officials

Name	Affiliation	Role
Yonghui Huang, archiater	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital	Recruiting	Beijing	Beijing Municipality	100101	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16533479	Background	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.
9852446	Background	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.

ID	Term
D010181	Pancreatic Cyst
D003560	Cysts
D009369	Neoplasms
D010182	Pancreatic Diseases