Post-ERCP BleedingNCT06107504
Prevention of Post-sphincterotomy Bleeding
A study testing Sucralfate in people with Post-ERCP Bleeding, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Post-ERCP Bleeding
- What is being tested?
- Sucralfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years who accept ERCP and sphincterotomy for common bile duct (CBD) stone extraction
Who cannot join
- Paitnets with no schedules for sphincterotomy
- Paitnets with unsuccessful CBD cannulation
- Patients with allergy to sucralfate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, Other (Non U.s.), 704
Hsueh-Chien Chiang, M.D., 2353535, scion456scion@gmail.com
About this study
Official title: Prevention of Post-sphincterotomy Bleeding by Endoscopic Tranexamic Acid and Sucralfate Administration: A Randomized Controlled Trial
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.
Read the detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic procedure combining endoscopy and fluoroscopy to diagnose and treat diseases of the pancreaticobiliary ductal system, including choledocholithiasis, biliary strictures, and cholangitis. ERCP is associated with a higher rate of complications than other endoscopic procedures, including post-ERCP pancreatitis (PEP), bleeding, perforation, and biliary tract infection. The incidence rate of ERCP-related complications has been reported at approximately 10 percent, with mortality rates ranging from 0.1 to 1.4 percent. Despite recent technological advancements and safety precautions, the ERCP procedure-related death rates have remained high.
Among all complications, delayed bleeding after sphincterotomy (EST) is a nightmare for both clinical physicians and endoscopists. Post-EST bleeding results in Tarry-bloody stool and anemia, increasing the mortality rate and hospital stay. While non-steroidal anti-inflammatory drugs (NSAIDs), pancreatic stents, and intravenous fluids can help prevent post-ERCP pancreatitis, there is no effective methodology or medication for bleeding prevention currently. Therefore, developing a prevention method for post-EST bleeding is urgent and important.
Tranexamic acid (TXA) is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen, thereby preventing blood clot lysis and reducing bleeding. A recent study evaluating the effect of topical tranexamic acid (TXA) powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect.
Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. With the protective effect of the papilla mucosa, sucralfate can cover the EST wound and has the potential to avoid further environmental damage. In combination with TXA powder in stabilizing the clotting, we expect the post-EST bleeding event will reduce. Therefore, this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate after EST can reduce the post-EST bleeding event.
- Conditions
- Post-ERCP Bleeding
- Being tested
- Sucralfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucralfateDrug
Also called Tranexamic acid
2g of sucralfate powder and 1g of tranexamic acid powder will be sprayed after EST
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (5)
The incident rate of post-EST wound bleeding requiring transarterial embolization or emergency surgery
The incident rate of post-EST wound bleeding requiring transarterial embolization or emergency surgery.
Measured: 14 days
The incidence rate of Hb loss > 2g/dL
The incidence rate of Hb loss > 2g/dL the day after ERCP
Measured: 3 days
The mortality rate
All-cause mortality after EST
Measured: 14 days
The incident rate post-ERCP pancreatitis
The incident rate post-ERCP pancreatitis after ERCP. The definition is epigastric pain and elevated lipase.
Measured: 14 days
The Hb loss
The Hb decreased level during post-EST bleeding or day 2 after EST
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2024
- Primary completion28 Feb 2025
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP BleedingStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsueh-Chien Chiang, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107504
- Sponsor's protocol ID
- B-BR-112-038
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD can be shared after publication
Publications
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.
PubMed 30979521Fujita 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.
PubMed 34963021Akshintala 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.
PubMed 34214449Leung 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.
PubMed 29722146Yu 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.
PubMed 37332745Chiang 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.
PubMed 37356632Masuelli 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.
PubMed 19832693Ala 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.
PubMed 27007594Chiang HC, Kang JW, Chang WL, Kuo TL, Chiang CM, Wu JS, Chen PJ, Chuang CH, Chen CY, Lin XZ, Lin MY. Topical tranexamic acid and sucralfate prevent delayed bleeding after endoscopic sphincterotomy: a randomized controlled trial (with video). Ther Adv Gastroenterol. 2026 Apr 7;19:17562848261438597. doi: 10.1177/17562848261438597. eCollection 2026.
PubMed 41959715
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-sphincterotomy Bleeding by Endoscopic Tranexamic Acid and Sucralfate Administration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06107504
- Acronym / sponsor ID
- B-BR-112-038
- Conditions
- Post-ERCP Bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic procedure combining endoscopy and fluoroscopy to diagnose and treat diseases of the pancreaticobiliary ductal system, including choledocholithiasis, biliary strictures, and cholangitis. ERCP is associated with a higher rate of complications than other endoscopic procedures, including post-ERCP pancreatitis (PEP), bleeding, perforation, and biliary tract infection. The incidence rate of ERCP-related complications has been reported at approximately 10 percent, with mortality rates ranging from 0.1 to 1.4 percent. Despite recent technological advancements and safety precautions, the ERCP procedure-related death rates have remained high.
Among all complications, delayed bleeding after sphincterotomy (EST) is a nightmare for both clinical physicians and endoscopists. Post-EST bleeding results in Tarry-bloody stool and anemia, increasing the mortality rate and hospital stay. While non-steroidal anti-inflammatory drugs (NSAIDs), pancreatic stents, and intravenous fluids can help prevent post-ERCP pancreatitis, there is no effective methodology or medication for bleeding prevention currently. Therefore, developing a prevention method for post-EST bleeding is urgent and important.
Tranexamic acid (TXA) is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen, thereby preventing blood clot lysis and reducing bleeding. A recent study evaluating the effect of topical tranexamic acid (TXA) powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect.
Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. With the protective effect of the papilla mucosa, sucralfate can cover the EST wound and has the potential to avoid further environmental damage. In combination with TXA powder in stabilizing the clotting, we expect the post-EST bleeding event will reduce. Therefore, this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate after EST can reduce the post-EST bleeding event.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: SucralfateAfter 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. |
| 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥ 18 years who accept ERCP and sphincterotomy for common bile duct (CBD) stone extraction
Key exclusion criteria (3 listed)
- Paitnets with no schedules for sphincterotomy
- Paitnets with unsuccessful CBD cannulation
- Patients with allergy to sucralfate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SucralfateAlso: Tranexamic acid2g of sucralfate powder and 1g of tranexamic acid powder will be sprayed after EST | Drug | Intervention group |
Primary outcome
The incident rate of delayed post-ERCP bleeding during the study period
Time frame: 14 days
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.
5 secondary outcomes
The incident rate of post-EST wound bleeding requiring transarterial embolization or emergency surgery
Time frame: 14 days
The incidence rate of Hb loss > 2g/dL
Time frame: 3 days
The mortality rate
Time frame: 14 days
The incident rate post-ERCP pancreatitis
Time frame: 14 days
The Hb loss
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Results publication: PubMed 30979521ASGE 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.
- Results publication: PubMed 34963021Fujita 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.
- Results publication: PubMed 34214449Akshintala 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.
- Results publication: PubMed 29722146Leung 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.
- Results publication: PubMed 37332745Yu 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.
- Results publication: PubMed 37356632Chiang 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.
- Results publication: PubMed 19832693Masuelli 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.
- Results publication: PubMed 27007594Ala 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.
- Derived from this study: PubMed 41959715Chiang HC, Kang JW, Chang WL, Kuo TL, Chiang CM, Wu JS, Chen PJ, Chuang CH, Chen CY, Lin XZ, Lin MY. Topical tranexamic acid and sucralfate prevent delayed bleeding after endoscopic sphincterotomy: a randomized controlled trial (with video). Ther Adv Gastroenterol. 2026 Apr 7;19:17562848261438597. doi: 10.1177/17562848261438597. eCollection 2026.
- Individual participant dataSharing planned: Undecided. IPD can be shared after publication
Related trials for Post-ERCP Bleeding
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Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucralfate in people with Post-ERCP Bleeding, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsueh-Chien Chiang, M.D. (2353535 ext. 9118, scion456scion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incident rate of delayed post-ERCP bleeding during the study period (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107504, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.