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Blood Pressure During ESD is Related With the Postoperative Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070665
Recruitment Status : Unknown
Verified March 2017 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : March 3, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:

Endoscopic submucosal dissection(ESD) is a prominent minimally invasive operation technique for treating early gastrointestinal tumor. But promoting ESD is uneasy because of its complications such as postoperative bleeding, perforation and so on. So if we decrease the rate of postoperative bleeding, ESD might be better popularized. Some study indicated that hypertension was the independent risk factor of postoperative bleeding. Endoscopic center of Fudan University Zhongshan Hospital is a rich experienced medical unit in doing ESD operation in China. Referring to our experience, if we can use some special methods to find the potential bleeding spot which is not obvious during ESD operation and we coagulate it precisely, then we may control the risk of postoperative bleeding.

Based on the above hypothesis, our team designed this study to examine whether increasing blood pressure during gastric ESD could help to control the risk of postoperative bleeding.


Condition or disease Intervention/treatment Phase
Gastrointestinal Disease Gastrointestinal Bleeding Drug: Norepinephrine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Increasing Blood Pressure During Gastric ESD May Control the Risk of Postoperative Bleeding: a Prospective Randomized Trial
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Increasing blood pressure
Using norepinephrine pump as the initial dose is 0.05μg/Kg.min to increase the patient's blood pressure up to about 150 mmHg for 5 min during ESD.
Drug: Norepinephrine
Increasing blood pressure up to 150mmHg for 5min using norepinephrine pump as initial dose 0.05μg/Kg.min during ESD operation, meanwhile check out the potential hemorrhage spot which is not obvious and then use the hot biopsy forceps to coagulate the bleeding spot, after that withdraw the norepinephrine and record the potential bleeding spot's location. The other procedures are the same as control groups'.
Other Names:
  • ephedrine
  • phenylephedrine

No Intervention: Control group
Patients received normal ESD manipulation.



Primary Outcome Measures :
  1. PostESD bleeding [ Time Frame: 60 days ]
    Post-ESD bleeding was defined as clinical evidence of bleeding after ESD, manifesting as hematemesis or melena, which required urgent endoscopic treatment


Secondary Outcome Measures :
  1. Post-ESD perforation [ Time Frame: 60 days ]
    Post-ESD perforation was defined as the clinical symptoms such as abdominal pain, abdominal distension, fever and so on, then combined abdominal CT images.

  2. Hospitalization [ Time Frame: 60 days ]
    length of stay in hospital

  3. Post-ESD hemoglobin [ Time Frame: 60 days ]
    The patient's postoperative hemoglobin will be examined 24-48h after ESD operation, and will be analyzed by the software of SPSS19.0 compared with the figure of pre-operation.

  4. Post-ESD hemocrit [ Time Frame: 60 days ]
    The patient's postoperative hemocrit will be examined 24-48h after ESD operation, and will be analyzed by the software of SPSS19.0 compared with the figure of pre-operation.

  5. Post-ESD prothrombin time [ Time Frame: 60 days ]
    The patient's postoperative prothrombin time will be tested 24-48h after ESD operation, and will be analyzed by the software of SPSS19.0 compared with the figure of pre-operation.

  6. Post-ESD activated partial prothrombin time [ Time Frame: 60 days ]
    The patient's postoperative activated partial prothrombin time will be tested 24-48h after ESD operation, and will be analyzed by the software of SPSS19.0 compared with the figure of pre-operation.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A. The indications for ESD for gastric neoplasms, such as intramucosal gastric cancer and adenoma, include intramucosal differentiated tubular adenocarcinoma of any size without ulceration or signs of submucosal invasion and intramucosal differentiated-type adenocarcinoma of less than 3 cm with an ulcer scar. The histology, tumor location, and depth of invasion fulfilled the criteria of the Japanese Research Society for Gastric Cancer.

B. The eligible patients' blood coagulation function should be normal without any associated medicine influenced.

Exclusion Criteria:

  • A. Previously treated by radical gastrectomy. B. Pregnant or on breast feeding. C. Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism.

D. Coagulopathy: liver cirrhosis, thrombocytopenia. E. Anti-platelet agents. Allergic to PPI or norepinephrine. F. Patients with sever hypertension(systolic pressure>180mmHg), or the hypotensor cann't control blood pressure suitably.

G. Patients with cardiovascular and cerebrovascular events within 6 months.


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): NCT03070665


Contacts
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Contact: Lin Shengli, Dcotor +8602164041990 ext 2537 lin.shengli@zs-hospital.sh.cn
Contact: Zhou Pinghong, Doctor +8602164041990 ext 2537 zhou.pinghong@zs-hospital.sh.cn

Locations
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China, SHA
Zhongshan Hospital Recruiting
Shanghai, SHA, China, 200032
Contact: Shengli Lin, Doctor    +8618005101000    lin.shengli@zs-hospital.sh.cn   
Contact: Pinghong Zhou, Doctor    +8613681971063    zhou.pinghong@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Director: Zhou Pinghong, Doctor Shanghai Zhongshan Hospital of Fudan University
Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03070665    
Other Study ID Numbers: ZS-GI
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
endoscopic submucosal dissection
postoperation bleeding
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Norepinephrine
Ephedrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Central Nervous System Stimulants