NCT05550649

Brief Summary

Guided by clinical problems, this study focused on the problems encountered in clinical practice, with the interventional treatment of emergency gastrointestinal bleeding as the breakthrough point, and focused on the dilemma of treatment selection for patients with negative angiography in gastrointestinal bleeding. At present, there is no report on relevant clinical and basic research on the selection of treatment strategies for patients with negative ANVUGIB angiography. Whether prophylactic arterial embolization can benefit patients and whether it can reduce mortality is an urgent clinical problem to be solved.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 10, 2022

Last Update Submit

September 22, 2022

Conditions

Acute Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

  • postoperative rebleeding rate

    No more active bleeding within 1 month after surgery, or the bleeding volume is significantly reduced, and no blood transfusion is required

    1 month

Secondary Outcomes (5)

  • Hemoglobin

    1 month

  • blood transfusion volume

    1 month

  • complication rate

    1 month

  • mortality

    1 month

  • surgical intervention rate.

    1 month

Study Arms (2)

Prophylic Embolization

EXPERIMENTAL

Prophylactic arterial embolization is performed for the artery in the diseased blood supply area. The embolization material: gelatin sponge particles are recommended, and micro-steel ring can be used as an auxiliary if necessary; after operation, symptomatic and supportive treatment such as acid suppression, hemostasis, blood transfusion, and fluid replacement are given according to the condition.

Procedure: embolization

Sham Embolization

SHAM COMPARATOR

After the angiography was completed, no embolization was performed, the catheter was withdrawn, the vascular sheath was removed, and symptomatic and supportive treatments such as acid suppression, hemostasis, blood transfusion, and fluid replacement were given.

Procedure: embolization

Interventions

embolizationPROCEDURE

Prophylactic arterial embolization is performed for the artery in the diseased blood supply area. The embolization material: gelatin sponge particles are recommended, and micro-steel ring can be used as an auxiliary if necessary; after operation, symptomatic and supportive treatment such as acid suppression, hemostasis, blood transfusion, and fluid replacement are given according to the condition.

Prophylic EmbolizationSham Embolization

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18\~75 years old (including 18 years old and 75 years old);
  • Bleeding of gastric or duodenal ulcers that have failed endoscopic therapy;
  • Anastomotic bleeding after gastrointestinal anastomosis;
  • Anastomotic bleeding after cholangioenterostomy;
  • Bleeding after ERCP;
  • There were no indirect signs of contrast agent spillage and bleeding in angiography.

You may not qualify if:

  • Age: \<18 years old or \>75 years old;
  • Rupture and bleeding of gastric fundus esophageal varices;
  • Active bleeding can be seen on angiography;
  • Unexplained upper gastrointestinal bleeding;
  • Those who have undergone interventional therapy in the past;
  • Allergy to iodine-containing contrast agents;
  • Uncorrectable coagulation dysfunction and uncontrolled systemic infection;
  • There is functional failure of important organs (heart, liver, kidney, etc.);
  • History of gastrointestinal radiotherapy in the past 1 year;
  • Those who are not expected to complete the follow-up;
  • Expected survival shorter than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Embolization, Therapeutic

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Central Study Contacts

Shilong Han, Doctor

CONTACT

18917683645hanshilong86@163.com

Long Pan, Doctor

CONTACT

1891768571218917685712@189.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2022

First Posted

September 22, 2022

Study Start

September 30, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)