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Trial record 20 of 822 for:    Recruiting, Not yet recruiting, Available Studies | Bleeding

Over-the-scope Clips and Standard Treatments in Endoscopic Control of Acute Bleeding From Non-variceal Upper GI Causes

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ClinicalTrials.gov Identifier: NCT03216395
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
The First Affiliated Hospital of Soochow University
Beijing Friendship Hospital
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong

Brief Summary:
In the management of patients with acute upper gastrointestinal bleeding from non-variceal causes, endoscopic treatment and acid suppression are now the standard of care. Current endoscopic treatment in the form of either thermo-coagulation or clipping to the bleeding arteries is highly efficacious in the stopping bleeding. Unfortunately in 5 to 10% of patients, bleeding cannot be controlled during index endoscopy or recurs after initial hemostasis. These patients are often elderly with significant co-morbidities. Their bleeding lesions are large eroding into major sub-serosal arteries. In the few who need surgical salvage, mortality increases to around 30%. The Over-the-scope-Clip (OTSC) is a device, which allows endoscopists to capture a large amount of tissue and compress on the bleeding artery. The OTSC also has a high retention rate. Recurrent bleeding with the use of standard hemo-clips can occur because of their low retention rate. We reported the use of OTSC with a high success rate in a case series of patients with refractory bleeding after standard endoscopic treatment. We have also used OTSC in the treatment of bleeding from pseudo-aneurysm arising from large eroded arteries in ulcer base. A multicenter randomized controlled trial that compares OTSC to standard endoscopic treatment in the endoscopic treatment of refractory bleeding lesions has just been completed. The use of OTSC has been shown to be superior in achieving hemostatic control and reducing further bleeding. In this proposed randomized controlled trial, we would test the hypothesis that the use of OTSC, when used as the first or primary treatment, is superior to standard treatment in achieving hemostasis and thereby improve patients' outcomes.

Condition or disease Intervention/treatment Phase
Acute Upper Gastrointestinal Bleeding Tumor Bleeding Device: Over-the-scope Clips Device: Hemo-clipping Device: thermo-coagulation Drug: Epinephrine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients are randomized in a 1:1 ratio to receive; endoscopic treatment using OTSC or standard therapies Stratified randomization according to size of ulcers and non-ulcer lesions

  1. size smaller than10mm in diameter
  2. size equal to 10mm and less than 20mm in diameter
  3. size equal or greater than 20mm in diameter
  4. non-ulcer lesions
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Over-the-scope Clips and Standard Treatments in Endoscopic Control of of Acute Bleeding From Non-variceal Upper GI Causes(OTSC Study)
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Arm Intervention/treatment
Experimental: Over-the-scope Clips
Endoscopic Application of Over-the-scope Clips
Device: Over-the-scope Clips
Over-the-scope Clips is mounted onto a transparent cap, which is attached to the tip of the endoscope. To deploy the claw device, a cogwheel at the scope head is turned pulling a trip string. This in turn retracts the cap releasing the OTSC onto tissue.
Other Name: OTSC

Active Comparator: standard treatment
standard treatment of either hemo-clipping or thermo-coagulation with or without pre injection with diluted epinephrine <=20 clips or pulse
Device: Hemo-clipping
Hemo-clipping <=20 clips
Other Name: quick clips

Device: thermo-coagulation
contact thermo-coagulation < = 8 pulses
Other Name: contact thermo-coagulation

Drug: Epinephrine
epinephrine injection (diluted 1:1000) beneath peptic ulcer <20 mls
Other Name: adrenaline




Primary Outcome Measures :
  1. Bleeding free probability in 30 days after randomization [ Time Frame: 30 days ]
    Further bleeding is defined by failure to control bleeding during first endoscopy or recurrent bleeding after initial control.


Secondary Outcome Measures :
  1. re-interventions in the form of endoscopic [ Time Frame: 30 days ]
    heater probe or clips endoscpic therapy

  2. angiographic treatment [ Time Frame: 30 days ]
    angiopgram with embolization to bleeding vessel

  3. surgical treatment [ Time Frame: 30 days ]
    surgical treatment if primary failure or rebleeding

  4. blood transfusion 4. blood transfusion blood transfusion [ Time Frame: 30 days ]
    amount of total blood transfusion

  5. adverse events [ Time Frame: 30 days ]
    adverse events (related or unrelated to endoscopic treatment)

  6. mortality [ Time Frame: 30 days ]
    deaths from all causes

  7. cost analysis (Based on the cost data from the Hospital [ Time Frame: 30 days ]
    Authority Gazette, Hong Kong Special Administrative Region Government; the investigator will calculate cost to avert one episode of further clinical bleeding with the use of OTSC or standard treatment. A series of sensitivity analyses varying device costs and over a range of re-bleeding rates.)



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Ages Eligible for Study:   18 Years to 111 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with overt signs of acute upper GIB (melena, hematemesis, drop in hemoglobin with or without hypotension)
  • documented bleeding lesions suitable for standard endoscopic treatment during endoscopy

Exclusion Criteria:

  • without a full informed consent from the patient or his legally-acceptable representatives
  • Age <18 years
  • Pregnant
  • Lactating women
  • Moribund patients not considered for active treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216395


Contacts
Contact: James LAU, MD +85235051411 laujyw@surgery.cuhk.edu.hk
Contact: Bing-yee SUEN, BHSc +85235052640 suenbingyee@surgery.cuhk.edu.hk

Locations
China, Beijing
Beijing Friendship Hospital Recruiting
Beijing, Beijing, China
Contact: SIUJING SUN, MD    010-63014411    'sunxiujing@ccmu.edu.cn   
China, Jiangsu
The First Affliated Hospital of SooChow University Not yet recruiting
Suzhou, Jiangsu, China
Contact: chenhuan Tan, MD    0512-65223637    tanchenhuan2013@163.com   
China, Zhejiang
The First Affliated Hospital, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China
Contact: lan li, MD    071-87236666    doxtorlilan@163.com   
Ningbo First Hospital Not yet recruiting
Ningbo, Zhejiang, China
Contact: Bujiang Wang, MD    0574-87085588    061050225@163.com   
Hong Kong
Endoscopy Centre, Prince of Wales Hospital Recruiting
Hong Kong, N.t., Hong Kong
Contact: James YW LAU, MD    +852350522640    laujyw@surgery.cuhk.edu.hk   
Contact: Bing-yee SUEN, MHSc    +85235052640    suenbingyee@surgery.cuhk.edu.hk   
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: WK Leung, MD    +85222551674    wkleung@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Queen Mary Hospital, Hong Kong
The First Affiliated Hospital of Soochow University
Beijing Friendship Hospital
Investigators
Principal Investigator: James LAU, MD CUHK

Publications:
Swain CP, Lai KC, Kalabakas A, Grandison A, Pollock D. A comparison of size and pathology of vessel and ulcer in patients dying from bleeding gastric and duodenal ulcers. Gastroenterology 1993;104:suppl:A202.
Schmidt A, Goelder S, Messmann H, Goetz M, Kratt T, Meining A, Birk M, von Delius S, Albert J, Escher M, Lau JY, Hoffman A, Wiest R, Caca K, Over-the-scope-clips versus standard endoscopic therapy in patients with recurrent peptic ulcer bleeding-preliminary results of a prospective randomized, multicenter trial ("STING") (unpublished data)
http://www.asge.org/uploadedFiles/Publications_(public)/Practice_guidelines/Antithromb otics.pdf

Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03216395     History of Changes
Other Study ID Numbers: Oversco
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
beta-Endorphin
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists