Prospective, randomized controlled study evaluating a double-balloon interventional endoscopic platform for...

Area of Science:

• Gastroenterology
• Endoscopic Surgery
• Medical Device Technology

Background:

• Endoscopic submucosal dissection (ESD) for colorectal polyps can be lengthy and complex.
• A novel double-balloon interventional platform (DBIP) was developed to aid navigation, stabilization, traction, and device delivery during colorectal ESD.
• This study prospectively compares traditional ESD (T-ESD) with DBIP-assisted ESD (DBIP-ESD).

Purpose of the Study:

• To evaluate the efficacy and efficiency of DBIP-assisted ESD compared to traditional ESD for colorectal polyps.
• To determine the impact of DBIP on procedure time, resection rates, cost, and adverse events.

Main Methods:

• A prospective, randomized trial involving 140 patients with colorectal polyps ≥2 cm.
• Patients were randomized to either DBIP-ESD or T-ESD.
• Primary endpoint: mean total procedure time; Secondary endpoints: en bloc resection rate, cost, adverse events.

Main Results:

• DBIP-ESD significantly reduced mean procedure time by approximately 51 minutes (P < .001) and procedural costs by $610.16 per patient.
• Dissection speed increased by 49.0% with DBIP-ESD (P < .001).
• En bloc resection rates were superior with DBIP-ESD (97.2% vs. 87.0%, P = .030), with no reported adverse events.

Conclusions:

• DBIP-assisted ESD is a more efficient and cost-effective method for colorectal polyp removal.
• The platform enhances en bloc resection rates and simplifies defect closure, promoting wider adoption of ESD.
• DBIP represents a promising technological advancement for complex endoscopic procedures.