Blood Pressure During ESD is Related With the Postoperative Bleeding
Increasing Blood Pressure During Gastric ESD May Control the Risk of Postoperative Bleeding: a Prospective Randomized Trial
1 other identifier
interventional
296
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for not_applicable
Started Apr 2017
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedApril 26, 2017
March 1, 2017
1.5 years
February 23, 2017
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Post-ESD perforation
60 days
Hospitalization
60 days
Post-ESD hemoglobin
60 days
Post-ESD hemocrit
60 days
Post-ESD prothrombin time
60 days
- +1 more secondary outcomes
Study Arms (2)
Increasing blood pressure
EXPERIMENTALUsing 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.
Control group
NO INTERVENTIONPatients received normal ESD manipulation.
Interventions
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'.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital
Shanghai, SHA, 200032, China
Related Publications (7)
Ebi M, Shimura T, Nishiwaki H, Tanaka M, Tsukamoto H, Ozeki K, Sawada T, Mizoshita T, Mori Y, Kubota E, Tanida S, Kataoka H, Joh T. Management of systolic blood pressure after endoscopic submucosal dissection is crucial for prevention of post-ESD gastric bleeding. Eur J Gastroenterol Hepatol. 2014 May;26(5):504-9. doi: 10.1097/MEG.0000000000000072.
PMID: 24589830BACKGROUNDWatari J, Tomita T, Toyoshima F, Sakurai J, Kondo T, Asano H, Yamasaki T, Okugawa T, Ikehara H, Oshima T, Fukui H, Miwa H. Clinical outcomes and risk factors for perforation in gastric endoscopic submucosal dissection: A prospective pilot study. World J Gastrointest Endosc. 2013 Jun 16;5(6):281-7. doi: 10.4253/wjge.v5.i6.281.
PMID: 23772265BACKGROUNDKim JS, Chung MW, Chung CY, Park HC, Ryang DY, Myung DS, Cho SB, Lee WS, Joo YE. The need for second-look endoscopy to prevent delayed bleeding after endoscopic submucosal dissection for gastric neoplasms: a prospective randomized trial. Gut Liver. 2014 Sep;8(5):480-6. doi: 10.5009/gnl13226. Epub 2014 Feb 24.
PMID: 25228971BACKGROUNDMorgenstern LB, Demchuk AM, Kim DH, Frankowski RF, Grotta JC. Rebleeding leads to poor outcome in ultra-early craniotomy for intracerebral hemorrhage. Neurology. 2001 May 22;56(10):1294-9. doi: 10.1212/wnl.56.10.1294.
PMID: 11376176BACKGROUNDRyu SJ, Kim BW, Kim BG, Kim JH, Kim JS, Kim JI, Park JM, Oh JH, Kim TH, Kim JJ, Park SM, Park CH, Song KY, Lee JH, Kim SG, Kim DJ, Kim W. Endoscopic submucosal dissection versus surgical resection for early gastric cancer: a retrospective multicenter study on immediate and long-term outcome over 5 years. Surg Endosc. 2016 Dec;30(12):5283-5289. doi: 10.1007/s00464-016-4877-y. Epub 2016 Jun 23.
PMID: 27338583BACKGROUNDJang JS, Choi SR, Graham DY, Kwon HC, Kim MC, Jeong JS, Won JJ, Han SY, Noh MH, Lee JH, Lee SW, Baek YH, Kim MJ, Jeong DS, Kim SK. Risk factors for immediate and delayed bleeding associated with endoscopic submucosal dissection of gastric neoplastic lesions. Scand J Gastroenterol. 2009;44(11):1370-6. doi: 10.3109/00365520903194609.
PMID: 19891589BACKGROUNDSuzuki S, Chino A, Kishihara T, Uragami N, Tamegai Y, Suganuma T, Fujisaki J, Matsuura M, Itoi T, Gotoda T, Igarashi M, Moriyasu F. Risk factors for bleeding after endoscopic submucosal dissection of colorectal neoplasms. World J Gastroenterol. 2014 Feb 21;20(7):1839-45. doi: 10.3748/wjg.v20.i7.1839.
PMID: 24587661BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhou Pinghong, Doctor
Shanghai Zhongshan Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2017
First Posted
March 3, 2017
Study Start
April 1, 2017
Primary Completion
October 1, 2018
Study Completion
December 31, 2018
Last Updated
April 26, 2017
Record last verified: 2017-03