Hemostatic Forceps vs. Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

Gastroduodenal Ulcer Clinical Trial

Official title:

A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06393907
• Other study ID #: Si 223/2024
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: April 26, 2026

Study information

• Verified date: April 2024
• Source: Mahidol University
• Contact: Uayporn Kaosombattwattana, MD
• Phone: +66619245953
• Email: Koigi214[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.

Description:

This is a prospective randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. The primary outcome is comparing the hemostatic rates of the devices. Secondary outcomes are rebleeding rate at 7 and 30 days after index intervention, survival rate after intervention, procedure time for achieving hemostasis, number of units of infused blood, duration of hospitalization, and complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 26, 2026
• Est. primary completion date: March 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient with upper gastrointestinal hemorrhage age = 18 years old

2. The patient with gastroduodenal ulcer with indication for hemostatic intervention including 2.1 Forrest classification 1a (Active spurting) 2.2 Forrest classification 1b (Active oozing) 2.3 Forrest classification 2a (Non-bleeding visible vessel; NBVV) 2.4 Forrest classification 2b (Adherent clot) with lesion underneath clot which need hemostatic intervention including active spurting, active oozing or non-bleeding visible vessel

Exclusion Criteria:

1. Uncorrectable hemostasis laboratory including serum platelet < 50000 /mm3 or International Normalized Ratio (INR) >1.5

2. Bleeding from cancerous gastroduodenal ulcer

3. The patient with history of gastric surgery

4. The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment

5. The patient with history of proton pump inhibitor allergy

6. Pregnant

7. The patient deny to participate in the study

Related Conditions & MeSH terms

• Gastroduodenal Ulcer
• Peptic Ulcer
• Ulcer

Intervention

Device:
• Hemostatic Forceps
The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
• Bipolar Electrocautery Probes
The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.

Locations

Country	Name	City	State
Thailand	Faculty of internal medicine siriraj hospital, Mahidol university	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

Arima S, Sakata Y, Ogata S, Tominaga N, Tsuruoka N, Mannen K, Shiraishi R, Shimoda R, Tsunada S, Sakata H, Iwakiri R, Fujimoto K. Evaluation of hemostasis with soft coagulation using endoscopic hemostatic forceps in comparison with metallic hemoclips for bleeding gastric ulcers: a prospective, randomized trial. J Gastroenterol. 2010 May;45(5):501-5. doi: 10.1007/s00535-009-0186-8. Epub 2009 Dec 25. — View Citation

Asge Technology Committee; Conway JD, Adler DG, Diehl DL, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Mamula P, Rodriguez SA, Tierney WM. Endoscopic hemostatic devices. Gastrointest Endosc. 2009 May;69(6):987-96. doi: 10.1016/j.gie.2008.12.251. No abstract available. — View Citation

ASGE technology committee; Parsi MA, Schulman AR, Aslanian HR, Bhutani MS, Krishnan K, Lichtenstein DR, Melson J, Navaneethan U, Pannala R, Sethi A, Trikudanathan G, Trindade AJ, Watson RR, Maple JT; ASGE Technology Committee Chair. Devices for endoscopic hemostasis of nonvariceal GI bleeding (with videos). VideoGIE. 2019 Jun 27;4(7):285-299. doi: 10.1016/j.vgie.2019.02.004. eCollection 2019 Jul. — View Citation

Bianco MA, Rotondano G, Marmo R, Piscopo R, Orsini L, Cipolletta L. Combined epinephrine and bipolar probe coagulation vs. bipolar probe coagulation alone for bleeding peptic ulcer: a randomized, controlled trial. Gastrointest Endosc. 2004 Dec;60(6):910-5. doi: 10.1016/s0016-5107(04)02232-1. — View Citation

Charatcharoenwitthaya P, Pausawasdi N, Laosanguaneak N, Bubthamala J, Tanwandee T, Leelakusolvong S. Characteristics and outcomes of acute upper gastrointestinal bleeding after therapeutic endoscopy in the elderly. World J Gastroenterol. 2011 Aug 28;17(32):3724-32. doi: 10.3748/wjg.v17.i32.3724. — View Citation

Forrest JA, Finlayson ND, Shearman DJ. Endoscopy in gastrointestinal bleeding. Lancet. 1974 Aug 17;2(7877):394-7. doi: 10.1016/s0140-6736(74)91770-x. No abstract available. — View Citation

Kim JW, Jang JY, Lee CK, Shim JJ, Chang YW. Comparison of hemostatic forceps with soft coagulation versus argon plasma coagulation for bleeding peptic ulcer--a randomized trial. Endoscopy. 2015 Aug;47(8):680-7. doi: 10.1055/s-0034-1391565. Epub 2015 Mar 2. — View Citation

Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7. — View Citation

Nunoue T, Takenaka R, Hori K, Okazaki N, Hamada K, Baba Y, Yamasaki Y, Kono Y, Seki H, Inokuchi T, Takemoto K, Taira A, Tsugeno H, Fujiki S, Kawahara Y, Okada H. A Randomized Trial of Monopolar Soft-mode Coagulation Versus Heater Probe Thermocoagulation for Peptic Ulcer Bleeding. J Clin Gastroenterol. 2015 Jul;49(6):472-6. doi: 10.1097/MCG.0000000000000190. — View Citation

Toka B, Eminler AT, Karacaer C, Uslan MI, Koksal AS, Parlak E. Comparison of monopolar hemostatic forceps with soft coagulation versus hemoclip for peptic ulcer bleeding: a randomized trial (with video). Gastrointest Endosc. 2019 Apr;89(4):792-802. doi: 10.1016/j.gie.2018.10.011. Epub 2018 Oct 17. — View Citation

Veitch AM, Radaelli F, Alikhan R, Dumonceau JM, Eaton D, Jerrome J, Lester W, Nylander D, Thoufeeq M, Vanbiervliet G, Wilkinson JR, Van Hooft JE. Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update. Gut. 2021 Sep;70(9):1611-1628. doi: 10.1136/gutjnl-2021-325184. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes	When the bleeding stopped for at least 2 minutes, it is defined as successful hemostasis.	During esophagogastroduodenoscopy
Secondary	Rebleeding rate at 7 days and 30 days after index intervention	After primary hemostasis, patients will be follow up at 7 and 30 days for evidence of rebleeding.	30 days
Secondary	Survival rate after intervention	Patients who live longer than 30 days after hemostasis will be counted for survival rate.	30 days
Secondary	Procedure time for achieving hemostasis	Procedure time will be counted from the time of device insertion to the time of achieving hemostasis.	During esophagogastroduodenoscopy
Secondary	Number of units of infused blood	Number of red cell units which are transfused to the patients.	30 days
Secondary	Duration of hospitalization	The length of hospital stay.	30 days
Secondary	Complications of hemostatic interventions	Complications related to intervention include perforation, infection, and organ failure	30 days