Gastrointestinal DiseaseNCT03070665
Blood Pressure During ESD is Related With the Postoperative Bleeding
A study testing Norepinephrine in people with Gastrointestinal Disease and Gastrointestinal Bleeding, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Gastrointestinal Disease, Gastrointestinal Bleeding
- What is being tested?
- Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- The eligible patients' blood coagulation function should be normal without any associated medicine influenced.
Who cannot join
- 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.
- 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.
- Patients with cardiovascular and cerebrovascular events within 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, SHA, 200032
Shengli Lin, Doctor, +8618005101000, lin.shengli@zs-hospital.sh.cn
Pinghong Zhou, Doctor, +8613681971063, zhou.pinghong@zs-hospital.sh.cn
About this study
Official title: Increasing Blood Pressure During Gastric ESD May Control the Risk of Postoperative Bleeding: a Prospective Randomized Trial
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.
- Being tested
- Norepinephrine
- Keywords
- endoscopic submucosal dissection, postoperation bleeding
- Medical subject headings
- Gastrointestinal Diseases, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called ephedrine, phenylephedrine
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'.
| Study group | Role | What they receive |
|---|---|---|
| Increasing blood pressure | Experimental | 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. Receives: Drug: Norepinephrine |
| Control group | No intervention | Patients received normal ESD manipulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PostESD bleeding
Post-ESD bleeding was defined as clinical evidence of bleeding after ESD, manifesting as hematemesis or melena, which required urgent endoscopic treatment
Measured: 60 days
Secondary outcomes (6)
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.
Measured: 60 days
Hospitalization
length of stay in hospital
Measured: 60 days
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.
Measured: 60 days
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.
Measured: 60 days
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.
Measured: 60 days
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Apr 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhou Pinghong, Doctor, Study director, Shanghai Zhongshan Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070665
- Sponsor's protocol ID
- ZS-GI
- Status last verified
- Mar 2017
- First submitted
- 23 Feb 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24589830Watari 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.
PubMed 23772265Kim 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.
PubMed 25228971Morgenstern 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.
PubMed 11376176Ryu 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.
PubMed 27338583Jang 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.
PubMed 19891589Suzuki 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.
PubMed 24587661
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Blood Pressure During Gastric ESD May Control the Risk of Postoperative Bleeding: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03070665
- Acronym / sponsor ID
- ZS-GI
- Keywords
- endoscopic submucosal dissection, postoperation bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increasing blood pressure | Experimental | Drug: NorepinephrineUsing 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 intervention | –Patients received normal ESD manipulation. |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- The eligible patients' blood coagulation function should be normal without any associated medicine influenced.
Key exclusion criteria (3 listed)
- 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.
- 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.
- Patients with cardiovascular and cerebrovascular events within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineAlso: ephedrine, phenylephedrineIncreasing 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'. | Drug | Increasing blood pressure |
Primary outcome
PostESD bleeding
Time frame: 60 days
Post-ESD bleeding was defined as clinical evidence of bleeding after ESD, manifesting as hematemesis or melena, which required urgent endoscopic treatment
6 secondary outcomes
Post-ESD perforation
Time frame: 60 days
Hospitalization
Time frame: 60 days
Post-ESD hemoglobin
Time frame: 60 days
Post-ESD hemocrit
Time frame: 60 days
Post-ESD prothrombin time
Time frame: 60 days
Post-ESD activated partial prothrombin time
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 24589830Ebi 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.
- Background: PubMed 23772265Watari 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.
- Background: PubMed 25228971Kim 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.
- Background: PubMed 11376176Morgenstern 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.
- Background: PubMed 27338583Ryu 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.
- Background: PubMed 19891589Jang 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.
- Background: PubMed 24587661Suzuki 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.
- Individual participant dataSharing planned: Undecided
Related trials for Gastrointestinal Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhou Pinghong, Doctor study director
Shanghai Zhongshan Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine in people with Gastrointestinal Disease and Gastrointestinal Bleeding, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shengli, Dcotor (+8602164041990 ext. 2537, lin.shengli@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PostESD bleeding (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03070665, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.