A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis

NCT04876235 | Completed DMC

• 1 other identifier: 2021-03-221
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. As the advances in endoscopic techniques and accessories, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON). This article aims to compare the efficacy and safety of a double mushroom head metal stent and a double pigtail plastic stent in the treatment of encapsulated necrosis of the pancreas.

Conditions

Walled-off Necrosis

Keywords

endoscopic ultrasound guided drainage; Lumen-apposing metal stent; double-pigtail plastic stents; Walled-off necrosis

Outcome Measures

Primary Outcomes (1)

• clinical success (clinical improvement and resolution of WON)

  compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis

  two months

Secondary Outcomes (1)

• Adverse Events

  two months

Study Arms (2)

LAMS group

EXPERIMENTAL

place LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary

Procedure: endoscopic ultrasound; Device: lumen-apposing metal stent

DPPS group

ACTIVE COMPARATOR

Place DPPS under endoscopic ultrasound. When required, DEN was performed once the cystogastrostomy/duodenostomy tract had matured. This was done by first removing the stents followed by dilation of the tract with a radial expansion balloon and insertion of a forward viewing gastroscope through the tract for DEN

Procedure: endoscopic ultrasound; Device: double-pigtail plastic stents

Interventions

endoscopic ultrasound PROCEDURE

All patients were implanted with stents（DPPS or LAMS）under the EUS

DPPS group; LAMS group

lumen-apposing metal stent DEVICE

In the LAMS group, patients were stented with LAMS

LAMS group

double-pigtail plastic stents DEVICE

In the DPPS group, patients were stented with DPPS

DPPS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtention of a written informed consent
• According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON
• The diameter of WON ≥6cm
• Patient capable of fill in the quality of life questionnaire
• The distance between the EUS-probe and WON was \< 1 cm.

You may not qualify if:

• No written informed consent
• pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors
• pancreatic pseudocyst
• WON too far from the stomach and duodenum to perform endoscopic drainage
• Serious abnormalities in liver and kidney function and coagulation function
• Pregnant, parturient or breastfeeding women

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Jianfeng Yang

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Xiaofeng Zhang, M.S

  First People's Hospital of Hangzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy irector

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 6, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)