Clinical trial NCT04536428: ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding
Official title: ClearEndoclip Versus EZ Clip for the Hemostasis of Upper Gastrointestinal Ulcer Bleeding: an Open-label, Non-inferiority, Randomized, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peptic Ulcer Hemorrhage
Keywords: peptic ulcer
hemorrhage
stomach
duodenum
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Keimyung University Dongsan Medical Center
name: Korea University Anam Hospital
name: National Cancer Center, Korea
name: Nowon Eulji Medical Center
name: Pusan National University Hospital
name: Wonju Severance Christian Hospital
name: Inha University Hospital
name: Presbyterian medical center
First posted: 2020-09-02
Enrollment: 176
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are going to conduct a comparative study to analyze the clinical effectiveness and user convenience of EZ clips that have been used in upper gastrointestinal ulcer bleeding and newly developed clip (ClearEndoclip, FineMedix, Taegu) in Korea.

1) Research hypothesis and purpose

* This study was designed to prove the hypothesis that the hemostatic effect of newly developed endoscopic clip (ClearEndoclip, FineMedix, Taegu, Korea) is not inferior to that of EZ clip (Olympus, Tokyo, Japan) in the treatment of hemostasis for patients who visited the upper gastrointestinal ulcer bleeding.
* This study was designed as a multi-center (9 institutions), open-labelled, randomized comparative clinical trial (1:1 ratio).

Detailed description: 1. Design of this study

   1. Stratified randomization is performed, and the variable used for stratification is the patient's age (65 years or older, 65 years or less).
   2. The existing clip (control) and the domestic clip (experimental group) are divided by the block size randomization method of size 4 for each floor.
2. Patients and Methods

   1. inclusion criteria

      * Men and women aged 20 to 80
      * The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
      * American Society of Anesthesiologist (ASA) Physical Status 1 - 3
      * Patients with adequate patient compliance and adequate geographical distance for follow-up. character
   2. exclusion criteria

      * Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
      * Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
      * Patients with insufficient clinical information
      * Pregnant or lactating patients
      * Patients or guardians who have not obtained informed consent
   3. The number of patients

      * The number of subjects was calculated based on a non-inferiority study

        * The reported rate of rebleeding after hemostasis using the conventional hemoclip: about 5%.
        * 2.5% one-sided test, 80% power, and non-inferiority limit set to 10%

          * 75 subjects are required for each group, and 83 subjects are required if the drop rate is assumed to be 10%.
   4. Methods

      * After completing an informed consent form to the subjects who wish to participate in the study at the time of visit, basic clinical variables are checked.
      * First endoscopic hemostasis is performed. In this time, EZ clip is used for the subjects assigned to the control group, and ClearEndoclip is used for the subjects assigned to the experimental group to target blood vessels in the ulcer. At the same time, clinical parameters related to hemostasis are recorded.
      * After hemostasis is performed, rebleeding and complications are tracked up to 30 days after the procedure.
   5. Variables to be collected

      * At the time of visit: age, gender, height, weight, drug use (anticoagulant/antiplatelet agents, NSAIDs, steroids), underlying diseases (cirrhosis, diabetes, end-stage renal failure, heart disease, lung disease), hematological data, hemoglobin, Complete Rockall score
      * At the time of primary endoscopic hemostasis: location of ulcer, size of ulcer, size of exposed blood vessel (based on 2mm), forrest classification, total number of clips used, number of failed clips, usage and usage of epinephrine, procedure time (minutes) , Clip hemostasis success, treatment after clip hemostasis failure
      * After hemostasis: rebleeding (within 7 days), number of clips and bleeding from the follow-up endoscope after 48 hours, death within 30 days, ICU hospitalization date, total hospitalization date, complications of hemostasis, Helicobacter pylori

Eligibility criteria: Inclusion Criteria:

* Men and women aged 20 to 80
* The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
* American Society of Anesthesiologist (ASA) Physical Status 1 - 3
* Patients with adequate patient compliance and adequate geographical distance for follow-up. character

Exclusion Criteria:

* Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
* Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
* Patients with insufficient clinical information
* Pregnant or lactating patients
* Patients or guardians who have not obtained informed consent

Primary outcomes:
measure: Rebleeding rate after endoscopic hemostasis
timeFrame: upto 7 days
Secondary outcomes:
measure: Satisfaction scores of the operator and the assistant
timeFrame: during endoscopic procedure
measure: Failure rate of clip installation
timeFrame: during endoscopic procedure
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Sun Gyo Lim
state: Gyeonggi
Study officials:
affiliation: Department of Gastroenterology, Ajou University School of Medicine
name: Sun Gyo Lim
role: PRINCIPAL_INVESTIGATOR
References: