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Tranexamic Acid During Upper GI Endoscopic Resection Procedures

Primary Purpose

Gastric Polyp, Gastric Neoplasm, Duodenal Neoplasms

Status
Recruiting
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Tranexamic acid
Epinephrine injection
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Polyp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: patients with histories of allergic reactions to TXA history of seizures pregnancy

Sites / Locations

  • Shamir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tranexamic acid

Epinephrine

Arm Description

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).

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%.

Outcomes

Primary Outcome Measures

Intraprocedural bleeding
To compare the severity of intraprocedural bleeding between those receiving TXA and those receiving epinephrine.
Postprocedural bleeding
To compare the severity of postprocedural bleeding between those receiving TXA and those receiving epinephrine.

Secondary Outcome Measures

Side effects
To compare the number and severity of occurrences of abdominal pain, tachycardia, and hypertension between those receiving TXA and those r receiving epinephrine.

Full Information

First Posted
January 5, 2023
Last Updated
August 6, 2023
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05688020
Brief Title
Tranexamic Acid During Upper GI Endoscopic Resection Procedures
Official Title
Comparison Between Epinephrine Versus Tranexamic Acid Usage During Upper Gastrointestinal Tract Endoscopic Resection Procedures for the Reduction of Intraprocedural and Postprocedural Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.
Detailed Description
Endoscopic resection (ER) is an endoscopic technique used for the removal of sessile or flat neoplasms confined to the superficial layers (mucosa and submucosa) of the gastrointestinal (GI) tract. This technique is not without risk, and clinically significant intraprocedural bleeding and post-ER bleeding remain the most frequently encountered serious adverse event. The bleeding rate associated with ER varies for the different regions of the GI tract. This is most probably due to differences in the vascularity within the wall of the GI tract in each region. Intraprocedural bleeding in the stomach and duodenum is more frequent and may be as high as 11.5% and 19.3%, respectively. Delayed bleeding has been reported at about 5% for these sites. Management of bleeding is often resource intensive and may necessitate hospitalization, blood transfusion, and repeat intervention. Some techniques, such as soft coagulation with the tip of a snare; epinephrine injection; hemoclip placement or proton-pump inhibitor treatment, are used to decrease the risk of bleeding or treat active bleeding. Diluted epinephrine, which causes vasoconstriction, is often added to the submucosal injection fluid because of the theoretical benefit of decreasing bleeding. However, epinephrine has a short time-of-action and for long procedures it requires multiple doses to be injected. This can result in systemic effects such as severe hypertension, ventricular tachycardia, and intestinal ischemia, and may also increase postprocedural pain and prolong patient observation after the procedure. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects by inhibition of lysine binding sites on plasminogen molecules and therefore stabilizes the fibrin meshwork produced by secondary hemostasis. TXA was patented by Dr. S. Okamoto in 1957, and it was found to be significantly more potent than a precursor molecule known as epsilon-amino-caproic acid. During the past few years, TXA has been 'rediscovered' and is currently used in many conditions that are associated with either overt or occult hemorrhage. It is one of the most frequently cited drugs in recent surgical publications involving nearly all surgical specialties. After the CRASH-2 study which showed that administration of TXA to bleeding trauma patients within 3 hours of injury significantly reduced the risk of death due to bleeding and all-cause mortality without increasing the risk of vascular occlusive events, it has become an important part of trauma management. It is also widely used in gynecological practice. Early treatment with TXA reduces death due to bleeding in women with post-partum hemorrhage, as well as total blood loss and transfusion requirements in hemorrhage after caesarean delivery. Therefore, TXA has been recommended by the WHO as part of postpartum hemorrhage management. TXA is also commonly used in orthopedic surgery, either systemically or topically, to reduce excessive bleeding and transfusion requirements. Other hemorrhagic conditions in which TXA has been shown effective are epistaxis, hemoptysis , endoscopic ear surgery , mastectomy, and hereditary hemorrhagic telangiectasia with bleeding. Topical use of TXA may be more beneficial than systemic use as it may provide a higher drug concentration on the wound surface with negligible systemic concentrations. Most publications concerning topically administered TXA come from orthopedic literature where instilling TXA as a bolus into the joint reduces bleeding. Recently, a study revealed that intradermal injections of TXA in dermatological surgery reduces bleeding, especially in those on anticoagulant medications. While TXA is an inhibitor of fibrinolysis, and therefore might theoretically increase the risk of thrombotic vascular events, most studies show no increased risk of thromboembolism. This finding has been consistent with all routes of TXA administration including IV, topical/intra-articular, and other routes. The most frequently described contraindications to TXA administration include patients with histories of allergic reactions to TXA, seizures, and patients with acute renal failure or chronic kidney disease. The investigators propose that the use of TXA in the injection gel during ER procedures will be as effective as epinephrine usage in reducing intraprocedural and postprocedural bleeding, while also decreasing the incidence of side effects including abdominal pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Polyp, Gastric Neoplasm, Duodenal Neoplasms, Esophageal Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This study is designed as a prospective, double-blinded, controlled, non-inferiority pilot study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Description
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).
Arm Title
Epinephrine
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Hexakapron
Intervention Description
Tranexamic acid will be injected as part of the injectate during endoscopic resection.
Intervention Type
Drug
Intervention Name(s)
Epinephrine injection
Other Intervention Name(s)
Adrenaline
Intervention Description
Epinephrine will be injected as part of the standard injectate used during endoscopic resection.
Primary Outcome Measure Information:
Title
Intraprocedural bleeding
Description
To compare the severity of intraprocedural bleeding between those receiving TXA and those receiving epinephrine.
Time Frame
During procedure
Title
Postprocedural bleeding
Description
To compare the severity of postprocedural bleeding between those receiving TXA and those receiving epinephrine.
Time Frame
2 weeks post-procedure
Secondary Outcome Measure Information:
Title
Side effects
Description
To compare the number and severity of occurrences of abdominal pain, tachycardia, and hypertension between those receiving TXA and those r receiving epinephrine.
Time Frame
2 weeks post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: patients with histories of allergic reactions to TXA history of seizures pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anton Bermont, MD
Phone
972-52-6944145
Email
bermont@doctor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sergei Vosko, MD
Email
sergeivosko@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Bermont, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shamir Medical Center
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Bermont, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26077453
Citation
ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.
Results Reference
background
PubMed Identifier
24143302
Citation
Park CH, Lee SK. Preventing and controlling bleeding in gastric endoscopic submucosal dissection. Clin Endosc. 2013 Sep;46(5):456-62. doi: 10.5946/ce.2013.46.5.456. Epub 2013 Sep 30.
Results Reference
background
PubMed Identifier
27931633
Citation
Libanio D, Pimentel-Nunes P, Dinis-Ribeiro M. Complications of endoscopic resection techniques for upper GI tract lesions. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):735-748. doi: 10.1016/j.bpg.2016.09.010. Epub 2016 Sep 14.
Results Reference
background
PubMed Identifier
22075541
Citation
Yang Z, Wu Q, Liu Z, Wu K, Fan D. Proton pump inhibitors versus histamine-2-receptor antagonists for the management of iatrogenic gastric ulcer after endoscopic mucosal resection or endoscopic submucosal dissection: a meta-analysis of randomized trials. Digestion. 2011;84(4):315-20. doi: 10.1159/000331138. Epub 2011 Nov 9.
Results Reference
background
PubMed Identifier
30809079
Citation
Castro R, Libanio D, Pita I, Dinis-Ribeiro M. Solutions for submucosal injection: What to choose and how to do it. World J Gastroenterol. 2019 Feb 21;25(7):777-788. doi: 10.3748/wjg.v25.i7.777.
Results Reference
background
PubMed Identifier
27308678
Citation
Watts G. Utako Okamoto. Lancet. 2016 Jun 4;387(10035):2286. doi: 10.1016/s0140-6736(16)30697-3. No abstract available.
Results Reference
background
PubMed Identifier
29567052
Citation
Montroy J, Hutton B, Moodley P, Fergusson NA, Cheng W, Tinmouth A, Lavallee LT, Fergusson DA, Breau RH. The efficacy and safety of topical tranexamic acid: A systematic review and meta-analysis. Transfus Med Rev. 2018 Feb 19:S0887-7963(17)30151-7. doi: 10.1016/j.tmrv.2018.02.003. Online ahead of print.
Results Reference
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Tranexamic Acid During Upper GI Endoscopic Resection Procedures

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