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Timing of Transmural Stent Removal in Necrotizing Pancreatitis

NCT04963868 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-07-15

No results posted yet for this study

Summary

Although metal stents have been widely used in the endoscopic step-up approach for necrotizing pancreatitis, the exact timing of transmural stent removal has not been well studied. In this prospective, open-label, randomized controlled study, we recruited and enrolled consecutive patients with necrotizing pancreatitis undergoing endoscopic transmural necrosectomy. Eligible participants were randomly assigned to case group (a novel strategy in which the stents were removed during the last necrosectomy when the necrosectomy endpoint was achieved) and control group (the conventional strategy in which the stents were removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by imaging). The primary endpoint was the incidence of composite complications within three months of enrollment.

Conditions

Interventions

PROCEDURE

Stent removed by the novel strategy

The stent was removed during the last necrosectomy when the endpoint of necrosectomy was achieved；

PROCEDURE

Stent removed by the conventional strategy

The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image.

Sponsors & Collaborators

  • The First Affiliated Hospital of Nanchang University

    lead OTHER

Principal Investigators

  • Yin Zhu, PhD · The First Affiliated Hospital of Nanchang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-06-01
Completion
2025-12-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04963868 on ClinicalTrials.gov