Blood Pressure During ESD is Related With the Postoperative Bleeding
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||296 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
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'.
No Intervention: Control group
Patients received normal ESD manipulation.
- 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
- 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.
- Hospitalization [ Time Frame: 60 days ]length of stay in hospital
- 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.
- 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.
- 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.
- 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.
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
|Contact: Lin Shengli, Dcotor||+8602164041990 ext firstname.lastname@example.org|
|Contact: Zhou Pinghong, Doctor||+8602164041990 ext email@example.com|
|Study Director:||Zhou Pinghong, Doctor||Shanghai Zhongshan Hospital of Fudan University|