Blood Pressure During ESD is Related With the Postoperative Bleeding

Not Applicable

• Conditions: Gastrointestinal Disease; Gastrointestinal Bleeding
• Interventions: Drug: Norepinephrine

• Registration Number: NCT03070665
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-23
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-03
• Study Start: 2017-04-01
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 296

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Increasing blood pressure	Norepinephrine	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.

Primary Outcome Measures

Name	Time	Method
PostESD bleeding	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

Name	Time	Method
Post-ESD perforation	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	60 days	length of stay in hospital
Post-ESD hemoglobin	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	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	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	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.

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, SHA, China