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

NCT06393907 | Recruiting DMC FDA Device

• 1 other identifier: Si 223/2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroduodenal Ulcer

Keywords

Hemostatic Forceps; Bipolar Electrocautery Probes; Gastroduodenal Ulcer; Rebleeding; Hemostasis; Peptic ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rebleeding rate at 7 days and 30 days after index intervention

  30 days

• Survival rate after intervention

  30 days

• Procedure time for achieving hemostasis

  During esophagogastroduodenoscopy

• Number of units of infused blood

  30 days

• Duration of hospitalization

  30 days

Study Arms (2)

Hemostatic forceps

EXPERIMENTAL

Hemostatic forceps will be used for control bleeding with electrocautery unit setting: 80 W, effect 4, soft coagulation mode for 1-2 seconds.

Device: Hemostatic Forceps

Bipolar electrocautery probes

ACTIVE COMPARATOR

Bipolar electrocautery probes will be used for control bleeding with electrocautery unit setting: effect 2, soft coagulation bipolar mode for 8-10 seconds.

Device: Bipolar Electrocautery Probes

Interventions

Hemostatic Forceps DEVICE

The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.

Also known as: Coagrasper (Olympus, Tokyo, Japan)

Hemostatic forceps

Bipolar Electrocautery Probes DEVICE

The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.

Also known as: Gold probe (Boston Scientific, Massachusetts, USA)

Bipolar electrocautery probes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient with upper gastrointestinal hemorrhage age ≥ 18 years old
• 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

You may not qualify if:

• Uncorrectable hemostasis laboratory including serum platelet \< 50000 /mm3 or International Normalized Ratio (INR) \>1.5
• Bleeding from cancerous gastroduodenal ulcer
• The patient with history of gastric surgery
• The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment
• The patient with history of proton pump inhibitor allergy
• Pregnant
• The patient deny to participate in the study

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (11)

• 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.

  PMID: 21990954 BACKGROUND

• 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.

  PMID: 4136718 BACKGROUND

• 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.

  PMID: 31334417 BACKGROUND

• 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.

  PMID: 19410037 BACKGROUND

• 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.

  PMID: 20033825 BACKGROUND

• 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.

  PMID: 25730283 BACKGROUND

• 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.

  PMID: 25083773 BACKGROUND

• 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.

  PMID: 30342026 BACKGROUND

• 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.

  PMID: 15605005 BACKGROUND

• 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.

  PMID: 22310222 BACKGROUND

• 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.

  PMID: 34362780 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Uayporn Kaosombatwattana, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uayporn Kaosombattwattana, MD

CONTACT

+66619245953; Koigi214@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be randomized for each intervention using sequentially numbered, opaque sealed envelopes after recruitment in the study. The care provider who uses the devices cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Hemostatic Forceps versus Bipolar Electrocautery Probes

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: March 26, 2024
• Primary Completion: March 26, 2026
• Study Completion: April 26, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

TH (1)