A prospective, randomized controlled, non inferiority clinical trial to evaluate the efficacy and safety of plasma radiofrequency therapy and one-time incision of duodenal papilla

Study on the efficacy and safety of plasma radiofrequency therapeutic instrument and disposable scalpel for incision of duodenal papilla

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100051283

Enrollment

Unknown

Registered

2021-09-17

Start date

2021-09-22

Completion date

Unknown

Last updated

2022-08-08

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

Conditions

Endoscopic Sphincterotomy

Interventions

experimental group:Plasma radiofrequency therapy device and disposable scalpel (Shanghai Nuoying)

control group:High Frequency Surgical System (ERBE) and Disposable High Frequency Papillotomy (OLYMPUS)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Be able to understand and voluntarily participate in this clinical trial, and voluntarily sign the informed consent form; 2. Age 18-75 years old (including 18 and 75 years old), regardless of gender; 3. Patients who need EST after B-ultrasound or CT or MRCP or liver function (laboratory examination) examination.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to coagulation dysfunction surgery or patients who are still taking anticoagulants within one week before surgery; 2. Patients with simple acute pancreatitis; 3. Patients who have undergone subtotal gastrectomy: Bi I's surgery, Bi's II surgery or Roux-en-Y gastrojejunal surgery; 4. Patients who fail selective bile duct intubation and need to undergo papillary sphincterotomy; 5. Patients with particularly difficult endoscopic papillotomy; 6. Patients with severe cardiopulmonary and renal insufficiency who cannot tolerate surgery; 7. Female patients with positive pregnancy test and lactation period; 8. Patients with cardiac pacemakers or other electronic implants; 9. Patients who are considered by the investigator to have other factors that are not suitable for inclusion or that affect the participation of subjects; 10. Patients who have participated in other clinical trial projects within three months.

Design outcomes

Primary

Measure	Time frame
Success rate of duodenal papillotomy;	—

Secondary

Measure	Time frame
Stability of plasma radiofrequency therapeutic instrument and disposable scalpel;	—

Countries

China

Contacts

Public ContactXu Jianguang

Quzhou People's Hospital

12689513@qq.com+86 15605702579

Outcome results

None listed

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