Prevention of Post-sphincterotomy Bleeding

NCT06107504 | Recruiting

• 1 other identifier: B-BR-112-038
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Aim: Endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy (EST) are standard treatments for choledocholithiasis. However, 10% of post-EST bleeding was reported. Currently, there are no effective methods or medications for the prevention of post-EST bleeding. This study aimed to investigate whether the local administration of TXA and sucralfate can reduce the post-EST bleeding event. Methods: This is a randomized clinical trial. Patients with choledocholithiasis scheduled for ERCP with EST at National Cheng Kung University Hospital and Siriraj Hospital were enrolled. The study will recruit 120 patients. After randomization, 60 patients will be classified into the intervention group and 60 into the control group. The participants will receive standard ERCP and EST for common bile duct stone removal. If immediate polypectomy bleeding occurs, the investigators will apply standard endoscopic therapy by either local injection of diluted epinephrine or heater probe coagulation. After then, the investigators will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the post-EST wound in the intervention group. All enrolled patients will be monitored for delayed bleeding for 14 days after the ERCP.

Conditions

Post-ERCP Bleeding

Outcome Measures

Primary Outcomes (1)

• The incident rate of delayed post-ERCP bleeding during the study period

  The occurrence of delayed post-ERCP bleeding during the study period. Delayed post-ERCP bleeding was defined as remarkable hematochezia or Tarry stool with endoscopic evidence of post-EST wound bleeding.

  14 days

Secondary Outcomes (5)

• The incident rate of post-EST wound bleeding requiring transarterial embolization or emergency surgery

  14 days

• The incidence rate of Hb loss > 2g/dL

  3 days

• The mortality rate

  14 days

• The incident rate post-ERCP pancreatitis

  14 days

• The Hb loss

  3 days

Study Arms (2)

Intervention group

EXPERIMENTAL

After the EST and stone extraction, we will randomly assign the patients to either a control or an intervention group. After EST, if immediate bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine or heater probe coagulation. After then, we will spray 1g of sucralfate powder and 0.5g of tranexamic acid powder through a duodenoscope precisely on the EST wound in the intervention group.

Drug: Sucralfate

Control group

NO INTERVENTION

After the EST and stone extraction, we will randomly assign the patients to either a control or an intervention group. After EST, if immediate bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine or heater probe coagulation.

Interventions

Sucralfate DRUG

2g of sucralfate powder and 1g of tranexamic acid powder will be sprayed after EST

Also known as: Tranexamic acid

Intervention group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years who accept ERCP and sphincterotomy for common bile duct (CBD) stone extraction

You may not qualify if:

• Paitnets with no schedules for sphincterotomy
• Paitnets with unsuccessful CBD cannulation
• Patients with allergy to sucralfate

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Other (Non U.s.), 704, Taiwan

RECRUITING

Related Publications (8)

• ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.

  PMID: 30979521 BACKGROUND

• Fujita K, Yazumi S, Matsumoto H, Asada M, Nebiki H, Matsumoto K, Maruo T, Takenaka M, Tomoda T, Onoyama T, Kurita A, Ueki T, Katayama T, Kawamura T, Kawamoto H; Bilio-pancreatic Study Group of West Japan. Multicenter prospective cohort study of adverse events associated with biliary endoscopic retrograde cholangiopancreatography: Incidence of adverse events and preventive measures for post-endoscopic retrograde cholangiopancreatography pancreatitis. Dig Endosc. 2022 Sep;34(6):1198-1204. doi: 10.1111/den.14225. Epub 2022 Feb 4.

  PMID: 34963021 BACKGROUND

• Akshintala VS, Sperna Weiland CJ, Bhullar FA, Kamal A, Kanthasamy K, Kuo A, Tomasetti C, Gurakar M, Drenth JPH, Yadav D, Elmunzer BJ, Reddy DN, Goenka MK, Kochhar R, Kalloo AN, Khashab MA, van Geenen EJM, Singh VK. Non-steroidal anti-inflammatory drugs, intravenous fluids, pancreatic stents, or their combinations for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021 Sep;6(9):733-742. doi: 10.1016/S2468-1253(21)00170-9. Epub 2021 Jun 30.

  PMID: 34214449 BACKGROUND

• Leung WK, But DY, Wong SY, Tong TS, Liu KS, Cheung KS, Tsang SH, Chok KS, Poon RT, Hung IF. Prevention of post-sphincterotomy bleeding by proton pump inhibitor: A randomized controlled trial. J Dig Dis. 2018 Jun;19(6):369-376. doi: 10.1111/1751-2980.12604. Epub 2018 May 24.

  PMID: 29722146 BACKGROUND

• Yu Z, He J, Cao R, Yang Z, Li B, Hong J, Chen Y, Zhu L. Proton pump inhibitor has no effect in the prevention of post-endoscopic sphincterotomy delayed bleeding: a prospective randomized controlled trial. Front Med (Lausanne). 2023 Jun 2;10:1179512. doi: 10.3389/fmed.2023.1179512. eCollection 2023.

  PMID: 37332745 BACKGROUND

• Chiang HC, Chen PJ, Yang EH, Hsieh MT, Shih IC, Cheng HC, Chang WL, Chen WY, Chiu HC, Kuo HY, Tsai WC, Lo YN, Yang KC, Chiang CM, Chen WC, Huang KK, Tseng HH, Chen CY, Lin XZ, Chuang CH. Precise application of topical tranexamic acid to enhance endoscopic hemostasis for peptic ulcer bleeding: a randomized controlled study (with video). Gastrointest Endosc. 2023 Nov;98(5):755-764. doi: 10.1016/j.gie.2023.06.013. Epub 2023 Jun 24.

  PMID: 37356632 BACKGROUND

• Masuelli L, Tumino G, Turriziani M, Modesti A, Bei R. Topical use of sucralfate in epithelial wound healing: clinical evidences and molecular mechanisms of action. Recent Pat Inflamm Allergy Drug Discov. 2010 Jan;4(1):25-36. doi: 10.2174/187221310789895649.

  PMID: 19832693 BACKGROUND

• Ala S, Saeedi M, Janbabai G, Ganji R, Azhdari E, Shiva A. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. Nutr Cancer. 2016;68(3):456-63. doi: 10.1080/01635581.2016.1153666. Epub 2016 Mar 23.

  PMID: 27007594 BACKGROUND

MeSH Terms

Interventions

Sucralfate; Tranexamic Acid

Intervention Hierarchy (Ancestors)

Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids

Central Study Contacts

Hsueh-Chien Chiang, M.D.

CONTACT

2353535; scion456scion@gmail.com

Xi-Zhang Lin, M.D.

CONTACT

2353535; linxz@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be recruited from the volunteers with choledocholithiasis at National Cheng Kung University Hospital and Siriraj Hospital. Eligible participants include patients aged ≥ 18 years who accept ERCP and sphincterotomy for common bile duct (CBD) stone extraction. Patient consent forms will be given and explained to all patients before the ERCP. Exclusion criteria include patients with no schedules for sphincterotomy, unsuccessful CBD cannulation, and allergy to sucralfate.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: January 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: July 31, 2025
• Last Updated: May 25, 2025

Record last verified: 2024-12

Locations

TW (1)