Blood Pressure During ESD is Related With the Postoperative Bleeding

Gastrointestinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03070665
• Other study ID #: ZS-GI
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2017
• Last updated: April 24, 2017
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2017
• Source: Shanghai Zhongshan Hospital
• Contact: Lin Shengli, Dcotor
• Phone: +8602164041990
• Email: lin.shengli[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: December 31, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Bleeding
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Hemorrhage
• Hemorrhage
• Postoperative Hemorrhage

Intervention

Drug:
• Norepinephrine
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'.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	SHA

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Jang 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. — View Citation

Kim 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. — View Citation

Morgenstern 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. — View Citation

Ryu 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. Epub 2016 Jun 23. — View Citation

Suzuki 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. — View Citation

Watari 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hospitalization	length of stay in hospital	60 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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