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The Preventive Effect of the Four-in-One PECS Prevention System on High-Risk PECS Patients: A Prospective, Multicenter, Randomized Controlled Study

The Preventive Effect of the Four-in-One PECS Prevention System on High-Risk PECS Patients: A Prospective, Multicenter, Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116046
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Gastrointestinal Tumors

Interventions

Control Group:1. Doctor Selection: Patients underwent surgery by their designated doctors according to the original treatment plan. 2. Endoscopic Surgical Procedure: Parameter Settings: Electro
Submucosal incision: Output 40W, Effect 2 for submucosal dissection
Output 40W, Effect 4 for coagulation. (1) Submucosal injection: A 1:10,000 adrenaline saline solution or 0.02% methylene blue solution was injected submucosally at multiple points around the edge of
instead, incisions were made to allow local dissection within a certain range. After dissecting the lesion in that area, further mucosal incisions were made progressively for continued dissection. If

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Basic Information Requirements (1) Age > 18 years and < 80 years. 2. Disease Diagnosis and Surgical Criteria (1) High-risk population for PECS (Post-ESD Coagulation Syndrome); (2) Normal preoperative body temperature; (3) Preoperative endoscopic examination reveals a lesion with a maximum basal diameter = 2 cm, meeting the indications for ESD treatment; (4) Single ESD procedure for the removal of a solitary lesion. 3. Other Criteria (1) The patient or their family members must be able to understand the study protocol, voluntarily agree to participate in the study, and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Basic Information Requirements (1) Age 80 years; (2) Patients with familial polyposis; (3) Pregnant or lactating women, or patients with conditions such as severe emphysema, interstitial pneumonia, or ischemic heart disease who cannot tolerate anesthesia or surgery. 2. Disease Diagnosis and Surgical Criteria (1) Circumferential lesions; (2) Patients with concomitant organic colorectal diseases or other intestinal disorders; (3) Patients with contraindications to ESD surgery. 3. Other Criteria (1) Inability of the patient or their family to understand the conditions and objectives of this study.

Design outcomes

Primary

MeasureTime frame
Post-ESD coagulation syndrome;

Secondary

MeasureTime frame
The rate of complete resection;The rate of R0;Intraoperative massive hemorrhage rate;Intraoperative perforation rate;Postoperative perforation rate;Postoperative bleeding rate;Postoperative pain level;Postoperative laboratory tests (white blood cell count and C-reactive protein);Postoperative maximum body temperature;Length of hospital stay;

Countries

China

Contacts

Public ContactHu Kefeng

The First Affiliated Hospital of Ningbo University

nbhkf@sina.cn+86 135 8650 5081

Outcome results

None listed

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