A new HF current generator with automatically controlled system (Endocut mode) for endoscopic...

Area of Science:

• Gastroenterology
• Minimally Invasive Surgery
• Medical Device Technology

Background:

• Endoscopic sphincterotomy (EST) is associated with complications like pancreatitis, hemorrhage, perforation, and cholangitis.
• A novel High-Frequency (HF) current generator with an automatically controlled cut system (Endocut) was developed to mitigate these risks.

Purpose of the Study:

• To compare the complication rates of sphincterotomy using a conventional current generator versus the new Endocut device.
• To evaluate the safety and efficacy of the Endocut system in reducing EST-related complications.

Main Methods:

• A prospective randomized trial involving 100 patients assigned to either conventional or Endocut generators.
• Documentation of abrupt/continuous cutting, papillotomy length, and immediate complications.
• Subsequent 2-year follow-up of 850 EST procedures using the new device.

Main Results:

• The Endocut device significantly reduced abrupt papillary roof opening (1 vs. 18 patients, P < 0.001) and mild bleeding (2 vs. 13 patients, P = 0.002) compared to the conventional generator.
• No significant differences were observed in sex, age, indication, sphincterotomy length, or mild pancreatitis.
• In 850 subsequent ESTs with the new unit: pancreatitis occurred in 2.8%, hemorrhages requiring transfusion in 1%, and concealed perforations in 0.3%.

Conclusions:

• The new HF current generator with Endocut facilitates controlled, bloodless sphincterotomies, reducing the risk of papillary hemorrhage.
• The Endocut system was found to be safer and more convenient by all examiners.
• This technology shows promise for improving the safety profile of endoscopic retrograde cholangiopancreatography.