search
Back to results

The Feasible Research of Infrared Endoscope to Diagnose Early Gastric Cancer

Primary Purpose

Early Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
infrared endoscopy
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Early Gastric Cancer focused on measuring Early gastric cancer, Infrared endoscope

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age:18-70
  2. Sex:unlimited;
  3. Group 1:patients with EGC,willing to receive treatment under endoscopy(EMR/ESD)
  4. Group 2:patients for screening,or have some general symptoms dyspepsia、epigastric pain)who need to be examined by endoscopy
  5. Informed consent issued

Exclusion Criteria:

  1. Severe liver and kidney disease;
  2. Iodine, seafood or other severe allergies history;
  3. Patients with severe heart or pulmonary disease which is not suitable for endoscopic examination
  4. Higher blood risk of esophageal varices
  5. Pregnant or lactating female
  6. Without patient's consent
  7. The investigator considers other condition which is not suitable for participation

Sites / Locations

  • Xijing Hospital of Digestive DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cancer group

Non-cancer group

Arm Description

All patients receive the infrared endoscopy after injecting indocyanine green(ICG) intravenously.

All patients receive the infrared endoscopy after injecting ICG intravenously.

Outcomes

Primary Outcome Measures

the lesion of early gastric cancer by infrared endoscopy
confirming that the lesion of early gastric cancer can gather indocyanine green and can be observed by the infrared endoscopy.

Secondary Outcome Measures

the invasive depth of early gastric cancer by infrared endoscopy

Full Information

First Posted
February 29, 2016
Last Updated
March 18, 2016
Sponsor
Xijing Hospital of Digestive Diseases
search

1. Study Identification

Unique Protocol Identification Number
NCT02710838
Brief Title
The Feasible Research of Infrared Endoscope to Diagnose Early Gastric Cancer
Official Title
The Feasible Research of Infrared Endoscope to Diagnose Early Gastric Cancer and Evaluate the Invasive Depth of Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The gastric cancer is the second most frequently diagnosed cancer and the third leading cause of cancer death in China.80%-90% patients were detected at middle and later stage.The five-year survival rate for advanced gastric cancer patients is less than 10% due to the shortage of effective treatment method.The five-year survival rate for early gastric cancer patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods do not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main method for confirming gastric cancer.But it is limited to identify early gastric cancer and it leads to the low diagnostic rate of early gastric cancer. Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric cancer, since the first report in the 1990s, people have been exploring in this field. Through intravenous injection of exogenous contrast medium, such as the indocyanine green, it makes mucosal lesions highlight,and avoids the interference of background light.If specific target molecular is linked to the contrast medium,the specific imaging of the lesion can be presented. What is more,due to the strong penetration power of infrared light,its imaging depth also increases significantly.Indocyanine green had also been demonstrated safe in clinical studies and widely used. On this basis,we apply for the research about near-infrared endoscopy to diagnose early gastric cancer,and discuss its feasibility of the infrared endoscopy to diagnose early gastric cancer and clinical value.
Detailed Description
The gastric cancer is the second most frequently diagnosed cancer and the third leading cause of cancer death in China.80%-90% patients were detected at middle and later stage.The five-year survival rate for advanced gastric cancer patients is less than 10% due to the shortage of effective treatment method.The five-year survival rate for early gastric cancer patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods do not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main method for confirming gastric cancer.But it is limited to identify early gastric cancer and it leads to the low diagnostic rate of early gastric cancer. Accurate diagnosis for early gastric cancer and the pretherapeutic estimation of the invasion depth is desired to determine suitable treatment.Presently,endoscopic submucosal dissection is the new effective minimally invasive treatment for early gastric cancer,which preserve the entire stomach and improve the patient's postoperative quality of life.But the estimation of invasion depth of gastric cancers should be confirmed before operation. Recently,some research suggest that narrow banding imaging and endoscopy ultrasonography are considered established means of diagnosis for early gastric cancer and depth.No formal quantitative review of the available evidence has been published that narrow banding imaging or endoscopy ultrasonography could accurately diagnose early gastric cancer and evaluate the invasive depth.This means still has great limitations.The sensitivity of narrow banding imaging diagnosis is only 60% which its high false positive rate,shorter wavelength and lighter penetration,and the result is influenced by histologic variety of early gastric cancer and inflammatory changes in the background mucosa;Although endoscopy ultrasonography achieves a diagnostic accuracy of over 80%,and its tomographic views facilitate objective assessments,it is occasionally difficult to obtain images with adequate quality, and its evaluation is highly dependent on operators' proficiency levels. Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric cancer, since the first report in the 1990 s, people have been exploring in this field. Through intravenous injection of exogenous contrast medium, such as the indocyanine green, it makes mucosal lesions highlight,and avoids the interference of background light.If specific target molecular is linked to the contrast medium,the specific imaging of the lesion can be presented. What is more,due to the strong penetration power of infrared light,its imaging depth also increases significantly.Indocyanine green had also been demonstrated safe in clinical studies and widely used, such assessment of liver function tests. At present,the research in this aspect is very few, a few clinical research results show that infrared endoscopic imaging has a larger value for differentiating between early gastric cancer and gastric adenoma, and the difference between early gastric cancer and gastric lesions is significantly correlated with the depth of cancer invasion. However, there is not a system research about the infrared imaging characteristics of gastric cancer and different precancerous status,and there is no infrared endoscopic imaging assessment criteria for diagnosis of gastric cancer. Recently, the investigators have completed the experiments on animals about infrared imaging, the results prove that it has good specificity to identify tumor lesion. On this basis,the investigators apply for the research about near-infrared endoscopy to diagnose early gastric cancer,and discuss its feasibility of the infrared endoscopy to diagnose early gastric cancer and clinical value.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
Keywords
Early gastric cancer, Infrared endoscope

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cancer group
Arm Type
Experimental
Arm Description
All patients receive the infrared endoscopy after injecting indocyanine green(ICG) intravenously.
Arm Title
Non-cancer group
Arm Type
Other
Arm Description
All patients receive the infrared endoscopy after injecting ICG intravenously.
Intervention Type
Device
Intervention Name(s)
infrared endoscopy
Intervention Description
Firstly use standard white light and narrow-band imaging to observe the lesion, and then inject the contrast medium ICG, after 2 minutes,switch to infrared light to observe, record the image data, then accomplish the examination.
Primary Outcome Measure Information:
Title
the lesion of early gastric cancer by infrared endoscopy
Description
confirming that the lesion of early gastric cancer can gather indocyanine green and can be observed by the infrared endoscopy.
Time Frame
up to two years
Secondary Outcome Measure Information:
Title
the invasive depth of early gastric cancer by infrared endoscopy
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age:18-70 Sex:unlimited; Group 1:patients with EGC,willing to receive treatment under endoscopy(EMR/ESD) Group 2:patients for screening,or have some general symptoms dyspepsia、epigastric pain)who need to be examined by endoscopy Informed consent issued Exclusion Criteria: Severe liver and kidney disease; Iodine, seafood or other severe allergies history; Patients with severe heart or pulmonary disease which is not suitable for endoscopic examination Higher blood risk of esophageal varices Pregnant or lactating female Without patient's consent The investigator considers other condition which is not suitable for participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuhui Liang, M.D.
Phone
86-13572885507
Email
liangsh@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Niu
Email
710257073@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaichun Wu, M.D., Prof.
Organizational Affiliation
Xijing Hospital of Digestive Diseases
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhui Liang, M.D.
Phone
86-13572885507
Email
liangsh@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Lu Niu
Email
710257073@qq.com
First Name & Middle Initial & Last Name & Degree
Shuhui Liang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Feasible Research of Infrared Endoscope to Diagnose Early Gastric Cancer

We'll reach out to this number within 24 hrs