NCT04963868

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

June 21, 2021

Last Update Submit

July 6, 2021

Conditions

Acute PancreatitisNecrotizing PancreatitisWalled-Off Necrosis

Keywords

Necrotizing pancreatitisEndoscopic transmural necrosectomyLumen-apposing metal stent

Outcome Measures

Primary Outcomes (1)

  • The incidence of composite complications

    The composite complications included new-onset organ failure or systemic complications、new-onset infectious pancreatic necrosis、abdominal or gastrointestinal bleeding, intestinal fistula, stent occlusion and stent migration.

    3 months

Secondary Outcomes (10)

  • The incidence of technical success

    3 months

  • The incidence of clinical success

    3 months

  • The number of endoscopic transmural necrosectomy sessions

    3 months

  • The number of additional endoscopic transmural necrosectomy sessions after stent removal

    3 months

  • Length of stent placement

    3 months

  • +5 more secondary outcomes

Study Arms (2)

The novel strategy group

EXPERIMENTAL

The stents were removed during the last necrosectomy when the endpoint of necrosectomy was achieved

Procedure: Stent removed by the novel strategy

The conventional strategy group

ACTIVE COMPARATOR

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

Procedure: Stent removed by the conventional strategy

Interventions

Stent removed by the novel strategyPROCEDURE

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

The novel strategy group
Stent removed by the conventional strategyPROCEDURE

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

The conventional strategy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with necrotizing pancreatitis according to the 2012 Atlanta classification criteria;
  • Patients aged between 18 and 65 years;
  • Patients who signed the informed consent;

You may not qualify if:

  • Patients without transmural stent placement;
  • Patients with transmural plastic stent not metal stent placement before enrollment;
  • Patients who underwent endoscopic transmural necrosectomy in other hospitals before admission;
  • Patients complicated with chronic pancreatitis;
  • Patients complicated with pancreatic tumor;
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

PancreatitisPancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Yin Zhu, PhD

    The First Affiliated Hospital of Nanchang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yin Zhu, PhD

CONTACT

86-791-88692507zhuyin27@sina.com

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
Physician-in-charge

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 15, 2021

Study Start

January 1, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2025

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations

CN(1)