A randomized, parallel controlled trial for evaluating the efficacy and safety of Bipolar Electro-Surgical Generator and Knife Combination in the treatment of digestive tract diseases

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025338

Enrollment

Unknown

Registered

2019-08-24

Start date

2019-09-02

Completion date

Unknown

Last updated

2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

digestive tract diseases

Interventions

EMR test group:EMR use Bipolar Electro-surgical Generator and Knife Combination

EMR control group:EMR use Monopolar Electro-surgical Generator and Knife Combination

ESD test group:ESD use Bipolar Electro-surgical Generator and Knife Combination

ESD control group:ESD use Monopolar Electro-surgical Generator and Knife Combination

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Obtain informed consent; 2. Aged 18 to 75 years, male or female; 3. Endoscopic examination suggested single colorectum lesions, which met the indications for endoscopic treatment and required EMR or ESD during treatment; 4. Patients are willing and able to follow the study protocol during the study period, including visit and examination of the trial procedures and plans.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Coagulation dysfunction or use of antiplatelet drugs, anticoagulants; 3. No major surgery was performed before the trial; 4. Complicated with severe cardiovascular and cerebrovascular diseases; 5. Patients with advanced gastrointestinal tumors; 6. Patients with high risk of anesthesia found in preoperative examination; 7. Patients are at greater medical risk due to serious, uncontrolled medical diseases, non-malignant systemic diseases or active, uncontrolled infections; 8. According to the researchers, endoscopic mucosal dissection is not suitable for patients.

Design outcomes

Primary

Measure	Time frame
Block removal rate;Incidence of postoperative perforation;	—

Secondary

Measure	Time frame
Availability of high frequency surgical systems;	—

Countries

China

Contacts

Public ContactWang Shi

Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital

wangshi@zjcc.org.cn+86 13588403693

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026