Clinical trial NCT03070665: Blood Pressure During ESD is Related With the Postoperative Bleeding
Official title: Increasing Blood Pressure During Gastric ESD May Control the Risk of Postoperative Bleeding: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Disease
Gastrointestinal Bleeding
Keywords: endoscopic submucosal dissection
postoperation bleeding
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 296
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: PostESD bleeding
timeFrame: 60 days
Secondary outcomes:
measure: Post-ESD perforation
timeFrame: 60 days
measure: Hospitalization
timeFrame: 60 days
measure: Post-ESD hemoglobin
timeFrame: 60 days
measure: Post-ESD hemocrit
timeFrame: 60 days
measure: Post-ESD prothrombin time
timeFrame: 60 days
measure: Post-ESD activated partial prothrombin time
timeFrame: 60 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: SHA
Study officials:
affiliation: Shanghai Zhongshan Hospital of Fudan University
name: Zhou Pinghong, Doctor
role: STUDY_DIRECTOR
References:
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