Blood Pressure During ESD is Related With the Postoperative Bleeding

NCT ID: NCT03070665

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-12-31

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.

Conditions

Gastrointestinal Disease; Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Increasing blood pressure

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.

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

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'.

Control group

Patients received normal ESD manipulation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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'.

Intervention Type: DRUG

Other Intervention Names

ephedrine; phenylephedrine

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhou Pinghong, Doctor

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital of Fudan University

Locations

Zhongshan Hospital

Shanghai, SHA, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Shengli, Dcotor

Role: CONTACT

lin.shengli@zs-hospital.sh.cn

+8602164041990 ext. 2537

Zhou Pinghong, Doctor

Role: CONTACT

zhou.pinghong@zs-hospital.sh.cn

+8602164041990 ext. 2537

Facility Contacts

Shengli Lin, Doctor

Role: primary

lin.shengli@zs-hospital.sh.cn

+8618005101000

Pinghong Zhou, Doctor

Role: backup

zhou.pinghong@zs-hospital.sh.cn

+8613681971063

References

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.

Reference Type: BACKGROUND

PMID: 24589830 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23772265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25228971 (View on PubMed)

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. doi: 10.1212/wnl.56.10.1294.

Reference Type: BACKGROUND

PMID: 11376176 (View on PubMed)

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. doi: 10.1007/s00464-016-4877-y. Epub 2016 Jun 23.

Reference Type: BACKGROUND

PMID: 27338583 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19891589 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24587661 (View on PubMed)

Other Identifiers

ZS-GI

Identifier Type: -

Identifier Source: org_study_id