Comparison Between Epinephrine Versus Tranexamic Acid Usage During Upper Gastrointestinal Tract Endoscopic Resection Procedures for the Reduction of Intraprocedural and Postprocedural Bleeding
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Endoscopic resection of gastrointestinal lesions may prevent cancer. However, resection is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. The investigators aim to evaluate the effect of local TXA on preventing intraprocedural and postprocedural bleeding in patients undergoing endoscopic mucosal resection (EMR) of upper gastrointestinal lesions.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients referred for endoscopic resection of a non-neoplastic and neoplastic lesions in the upper GI presenting to our tertiary academic center.
• Age \> 18 years
Locations
Other Locations
Israel
Shamir Medical Center
RECRUITING
Be’er Ya‘aqov
Contact Information
Primary
Anton Bermont, MD
bermont@doctor.com
972-52-6944145
Backup
Sergei Vosko, MD
sergeivosko@gmail.com
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2026-02
Participants
Target number of participants: 200
Treatments
Experimental: Tranexamic acid
During the ER procedure, de-identified injectate solution will be introduced. Study group: 9 ml of standart solution for injection \[Consisit of: 6 ml indigo carmine + 500 ml succinylated gelatin 4% (Gelofusine; B. Braun, Crissier, Switzerland)\] + 1 ml (100mg) of TXA (tranexamic acid).
Active_comparator: Epinephrine
During the ER procedure, de-identified injectate solution will be introduced. 9 ml of standart solution for injection \[Consisit of: 6 ml indigo carmine + 500 ml succinylated gelatin 4% (Gelofusine; B. Braun, Crissier, Switzerland)\] + 1 ml epinephrine 1:100,000 + 1 ml saline 0.9%.
Related Therapeutic Areas
Sponsors
Leads: Assaf-Harofeh Medical Center