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Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)

NCT ID: NCT03027895

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2020-09-30

Brief Summary

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The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.

Detailed Description

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Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.

Conditions

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Pancreatic Pseudocyst

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lumen-apposing metal stent(LAMS)

Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS

Group Type EXPERIMENTAL

Lumen-apposing metal stent (LAMS)

Intervention Type DEVICE

Endoscopic Ultrasound-guided Drainage of WON with LAMS

Double pigtail plastic stent(DPPS)

Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS

Group Type ACTIVE_COMPARATOR

Double pigtail plastic stent (DPPS)

Intervention Type DEVICE

Endoscopic Ultrasound-guided Drainage of WON with DPPS

Interventions

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Lumen-apposing metal stent (LAMS)

Endoscopic Ultrasound-guided Drainage of WON with LAMS

Intervention Type DEVICE

Double pigtail plastic stent (DPPS)

Endoscopic Ultrasound-guided Drainage of WON with DPPS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject with ages from 18-80 years old
2. Subject with pancreatic pseudocysts confirmed by CT
3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
5. Subject has the symptoms related with the pseudocyst
6. The consent form has been signed

Exclusion Criteria

1. Subject is younger than 18 years or older than 80 years
2. Pancreatic pseudocyst communicate with the main pancreatic duct
3. Subject can't accept the endoscopic procedure
4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
6. Subject with 2 or more than 2 cysts
7. Subject has blood coagulation dysfunction
8. Pregnant or subject has mental disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yiqi Du

OTHER

Sponsor Role lead

Responsible Party

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Yiqi Du

Professor

Responsibility Role SPONSOR_INVESTIGATOR

References

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Zhu HY, Xie P, Song YX, Li ZS, Jin ZD, Du YQ. Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial. Trials. 2018 Oct 11;19(1):549. doi: 10.1186/s13063-018-2901-3.

Reference Type DERIVED
PMID: 30305160 (View on PubMed)

Other Identifiers

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2017010302

Identifier Type: -

Identifier Source: org_study_id