Blood Pressure During ESD is Related With the Postoperative Bleeding

Study Overview
=================
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.

Official Title
-----------------
Increasing Blood Pressure During Gastric ESD May Control the Risk of Postoperative Bleeding: a Prospective Randomized Trial

Conditions
-----------------
Gastrointestinal Disease, Gastrointestinal Bleeding

Intervention / Treatment
-----------------
* Drug: Norepinephrine


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Increasing blood pressure<br>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<br>* 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'.<br>* Other names: phenylephedrine;|
| No Intervention: Control group<br>Patients received normal ESD manipulation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PostESD bleeding | Post-ESD bleeding was defined as clinical evidence of bleeding after ESD, manifesting as hematemesis or melena, which required urgent endoscopic treatment | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ESD perforation | Post-ESD perforation was defined as the clinical symptoms such as abdominal pain, abdominal distension, fever and so on, then combined abdominal CT images. | 60 days | 
| Hospitalization | length of stay in hospital | 60 days | 
| Post-ESD hemoglobin | 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. | 60 days | 
| Post-ESD hemocrit | 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. | 60 days | 
| Post-ESD prothrombin time | 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. | 60 days | 
| Post-ESD activated partial prothrombin time | 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. | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic submucosal dissection, postoperation bleeding