digestive tract early cancer or precancerous lesions
Conditions
Interventions
Treatment Group:Test device are used for submucosal injection during endoscopic submucosal dissection
Control Group:Normal saline are used for submucosal injection during endoscopic submucosal dissection
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 20 ~ 80 years old (including 20 and 80 years old); (2) Patients who plann to undergo endoscopic submucosal dissection of digestive tract; (3) The patients with digestive tract early cancer or precancerous lesions ranging from 5 to 30mm (including 5 and 30mm); (4) The latest endoscopy showed no submucosal infiltration; (5) Voluntarily participate and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Pregnant and lactating women; (2) Patients with other malignant tumors; (3) Patients whose lesions had received other endoscopic treatment; (4) suffering from blood system diseases, or abnormal coagulation function can not be corrected; (5) People who are taking anti-platelet aggregation or anticoagulant drugs and cannot stop taking them; (6) there is a history of serious diseases of important organs (cardiovascular system, lung, liver, kidney and nervous system); (7) Allergic to hyaluronic acid, or have a history of allergy to other materials covered by this test; (8) Participants in any other clinical trial within 30 days before signing the informed consent; (9) There are circumstances that other investigators consider inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate of endoscopic submucosal dissection; | — |
Secondary
| Measure | Time frame |
|---|---|
| total volume of endoscopic submucosal injection solution; | — |
Countries
China
Contacts
Public Contactzou duowu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed