Topical tranexamic acid and sucralfate prevent delayed bleeding after endoscopic sphincterotomy: a randomized controlled trial (with video)

Abstract

Background:

Endoscopic sphincterotomy (EST) is a standard treatment for choledocholithiasis. However, this approach carries a risk of delayed bleeding, which occurs in 2%–12% of all patients within 14 days postoperatively. Despite this risk, few effective measures are currently available for preventing delayed bleeding.

Objectives:

Tranexamic acid (TXA) is an antifibrinolytic agent that promotes hemostasis, and sucralfate is an antiulcer agent that forms a protective barrier over wounds. In this study, we investigated whether topical TXA and sucralfate application on post-EST wounds reduces the risk of delayed bleeding.

Design:

This prospective randomized controlled trial was conducted between December 2023 and December 2024 at a tertiary center.

Methods:

This study included patients with a naïve biliary major papilla and choledocholithiasis who were scheduled for EST. Patients who had unsuccessful common bile duct cannulation, were scheduled for biliary stent insertion without a sphincterotomy, underwent endoscopic papillary balloon dilatation instead of EST, or had any known biliary or pancreatic malignancies were excluded. The final cohort comprised 120 patients. After EST and stone removal, patients were randomized to an intervention group (n = 60) or a control group (n = 60) using a sealed envelope approach. In the intervention group, TXA (1 g) and sucralfate (2 g) were directly sprayed onto the wound. All patients were monitored for 14 days. The primary outcome was the occurrence of delayed post-EST bleeding during the observation period.

Results:

Freedom from delayed bleeding within 14 days was significantly longer in the intervention group than in the control group (p = 0.023). TXA and sucralfate application reduced the incidence of delayed post-EST bleeding (0% and 8.3%, respectively) and substantial blood loss (1.6% and 16.6%, respectively).

Conclusion:

Topical TXA and sucralfate application holds promise for preventing delayed post-EST bleeding.

Trial registration:

This study was registered at ClinicalTrials.gov (NCT06107504).

Keywords

bleeding endoscopic retrograde cholangiopancreatography endoscopic sphincterotomy sucralfate tranexamic acid

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure that combines endoscopy and fluoroscopy for the diagnosis and treatment of pancreaticobiliary ductal disorders, such as choledocholithiasis (bile duct stones), biliary strictures, and cholangitis (bile duct inflammation).¹ Although ERCP is essential for both diagnosis and treatment, it carries a higher risk of complications than do other endoscopic procedures. Common complications include post-ERCP pancreatitis (PEP), bleeding, perforation, and biliary tract infections. The overall incidence rate of ERCP-associated complications is approximately 10%, with severe complications occurring in approximately 24% of all patients who have complications.^2,3 The rate of ERCP-associated mortality ranges from 0.2% to 0.7%.^2,4 Despite technological advancements and enhanced safety protocols, the rate of ERCP-associated complications remains high.

Among all complications, delayed bleeding after endoscopic sphincterotomy (EST) represents a major challenge for clinicians and endoscopists. This complication often manifests as tarry or bloody stools and anemia, contributing to increased mortality risks and prolonged hospital stays. The incidence rate of clinically meaningful post-EST bleeding is approximately 2% in the general population and 12% in high-risk patients.^5–7 Risk factors for delayed bleeding include comorbidities such as liver cirrhosis and end-stage renal disease (ESRD), antiplatelet or anticoagulant agent use, intraprocedural bleeding, and endoscopist’s low technical experience (<200 ERCP procedures).⁵

Although interventions such as nonsteroidal anti-inflammatory drugs, pancreatic stents, and intravenous fluids can prevent PEP, few standardized methods or medications are currently available for preventing delayed post-EST bleeding.¹ Given the severity of delayed post-EST bleeding, which can lead to life-threatening conditions necessitating endoscopic hemostasis, transcatheter arterial embolization, or surgery, reliable preventive strategies should be urgently developed.

Tranexamic acid (TXA) is an antifibrinolytic agent that mitigates bleeding by inhibiting fibrin degradation.⁸ It exerts its effect by binding to tissue plasminogen, preventing blood clot lysis and thereby reducing excessive bleeding. Numerous studies have demonstrated the effectiveness of TXA in managing bleeding across various organs, except the gastrointestinal tract.⁹ Topical application of TXA reduces the risk of intraoperative bleeding and improves the quality of the surgical field in various surgeries, without inducing the major side effects associated with systemic administration.¹⁰ We previously demonstrated the efficacy of topical TXA powder in treating bleeding peptic ulcers.¹¹ For patients with chronic renal disease, the recommended maximum daily dose of TXA is 1 g.

Sucralfate is an aluminum hydroxide–sucrose octasulfate complex that binds to the wound base,¹² forming a protective barrier that shields the wound site from environmental damage, promotes angiogenesis, and facilitates mucosal healing.¹³ It has been widely used to treat various wounds and ulcers, such as skin wounds, oral ulcers, and peptic ulcers.^14,15 The standard daily dose of sucralfate is 2 g.

Given the hemostatic properties of TXA and the mucosal protective effects of sucralfate, we hypothesized that targeted endoscopic application of 1 g of TXA and 2 g of sucralfate to post-EST wound sites would enhance hemostasis and prevent delayed bleeding. To test this hypothesis, we evaluated the efficacy and safety of topical TXA and sucralfate application in preventing delayed post-EST bleeding.

Materials and methods

Study design and ethical approval

This single-center, prospective, randomized controlled trial was approved by our hospital’s institutional review board (approval number: B-BR-112-038). The study protocol was registered at ClinicalTrials.gov (registration ID: NCT06107504). The reporting of this study conforms to the Consolidated Standards of Reporting Trials (CONSORT 2025) statement.¹⁶ Informed consent was obtained from all patients before the use of their data. All authors had full access to the study data and have approved the final manuscript for publication.

Study cohort

This study included adults (⩾18 years) with a naïve biliary major papilla and choledocholithiasis who underwent EST for common bile duct (CBD) stone extraction at our hospital between December 2023 and December 2024. Patients receiving antiplatelet or anticoagulant therapy were instructed to discontinue their medications for a specific period before EST, as per the current guidelines.¹⁷ Before ERCP, consent forms were provided in writing and thoroughly explained to all participants. We excluded patients with a history of EST or endoscopic papillary balloon dilatation (EPBD), those with any known biliary or pancreatic malignancies, those with unsuccessful CBD cannulation, those scheduled for biliary stent insertion without a sphincterotomy, those undergoing EPBD instead of EST, and those with allergy to sucralfate or TXA.

Study procedure

ERCP was performed by experienced endoscopists, each of whom had completed >200 procedures. The procedure was performed using a TRUEtome 44 sphincterotome (1.5 mm × 20 mm; Boston Scientific, Marlborough, MA, USA) and an ESG-100 electrosurgical unit (35 W, PulseCut Slow mode; Olympus, Tokyo, Japan). The cutting length was set to a minimum of 0.5 cm and adjusted on the basis of stone size. Incisions were made at the 11–12 O’clock position.

Immediate bleeding was defined as bleeding persisting for >3 min during ERCP and necessitating endoscopic hemostasis.¹⁸ If immediate bleeding occurred after EST and stone extraction, standard therapies (local injection of diluted epinephrine or heater probe coagulation) were administered. After confirmation of bleeding cessation, before the end of the ERCP procedure, a sealed envelope was opened by an assistant outside the ERCP room. Patients were then randomly assigned to either an intervention group or a control group. Patients were not aware of their assigned group. In the intervention group, 1 g of TXA powder and 2 g of sucralfate powder were directly sprayed onto the post-EST wound by using a duodenoscope (Figure 1; Video).

Figure 1.

Topical TXA and sucralfate application on a post-EST wound. (a) The biliary major papilla was cannulated using a sphincterotome over a guidewire. (b) After standard sphincterotomy, stones were extracted from the common bile duct. (c) A catheter was inserted through the working channel and positioned 1–2 cm from the post-EST wound. (d) TXA (1 g) and sucralfate powder (2 g) were sprayed onto the post-EST wound.

To prepare the medication, 1 g of TXA powder was obtained by opening four Transamin capsules (250 mg per capsule; Daiichi Sankyo Taiwan, Taipei, Taiwan) by the clinical trial pharmacy of our hospital. In addition, 2 g of sucralfate powder was obtained by grinding four sucralfate tablets (500 mg each; Yung Shin Pharmaceutical Industrial, Taichung, Taiwan). These powdered drugs were then administered using a functional powder delivery system (a 7-F polyethylene catheter connected to an oxygen cannula and air source; propelling power: 1 L/min airflow).^11,19

After ERCP, patients were monitored for 14 days for delayed post-EST bleeding. Serum levels of total bilirubin and hemoglobin were measured 1 day after the procedure. Patients with tarry or bloody stools were instructed to seek immediate medical attention for diagnostic endoscopy. For patients using antiplatelets or anticoagulants, medications were resumed 2 days after ERCP. On day 14, participants were contacted by telephone to confirm the absence of bleeding events.

Group allocation

Patients were allocated to an intervention group or a control group (1:1 ratio) by using opaque sealed envelopes containing random numbers representing either group.²⁰ The allocation sequence was generated using a computer program for random sorting.²⁰ An assistant, who was not part of the clinical team, prepared the sealed envelopes. After enrollment, each patient received a sealed envelope indicating group allocation.

Outcomes

All patients were monitored for 14 days after EST, either during hospitalization or during outpatient follow-up. For patients reporting hematemesis or presenting with tarry or bloody stools, diagnostic endoscopy was performed to identify the source of bleeding. The primary outcome was the occurrence of delayed post-EST bleeding during the observation period, defined as bleeding occurring within 14 days after EST. Delayed post-EST bleeding was characterized by hematemesis, tarry or bloody stools, and endoscopically confirmed bleeding from the wound.¹⁸ To maintain blinding, follow-up endoscopic procedures for suspected bleeding were performed by endoscopists blinded to group allocation. Hemoglobin levels were measured 1 day after EST to determine the amount of blood lost after EST. The secondary outcomes were as follows: a hemoglobin loss of >2 g/dL, indicating substantial blood loss^21,22; bleeding from the post-EST wound necessitating transarterial embolization or emergency surgery; ERCP-associated complications (e.g., PEP, cholangitis, and bowel perforation); and all-cause mortality.

Statistical analysis

In accordance with the literature, the rate of delayed post-EST bleeding in the control group was set to 5%,^7,23 and the rate of bleeding following topical TXA and sucralfate application was estimated to be 0.25%.^11,19 Sample size was calculated through a survival analysis over a 14-day period. The calculation indicated that a minimum of 56 patients per group was required to reject the null hypothesis of equal effects between the two groups and to achieve a power probability of 0.8 and a type I error rate of 0.05. Assuming a 5% dropout rate, we sought to enroll 120 patients, 60 per group, to ensure adequate statistical power.

Baseline and outcome data were analyzed using Student’s t test, Mann–Whitney U test, Chi-square test, or Fisher’s exact test. A one-tailed test was used for the primary outcome because the control group received no prophylactic intervention. Kaplan–Meier survival curves for delayed post-EST bleeding were compared between the two groups by using a log-rank test. Univariate and multivariate logistic regression analyses were performed to identify key risk factors for substantial blood loss on day 2. A p value of <0.05 indicated statistical significance. All statistical analyses were performed using SPSS (version 25.0; IBM, Armonk, NY, USA).

Results

From December 2023 to December 2024, we screened 178 potentially eligible patients for enrollment. Patients were excluded if they had unsuccessful CBD cannulation (n = 2), had a history of EST or EPBD (n = 8), were scheduled for biliary stent insertion without a sphincterotomy (n = 30), underwent EPBD instead of EST (n = 7), or had any known biliary or pancreatic malignancies (n = 11). The final cohort comprised 120 patients, 60 per group. No participant underwent EST plus EPBD. Figure 2 presents a flowchart depicting patient selection.

Figure 2.

Flowchart depicting patient selection.

Baseline characteristics, pre-ERCP blood test results, comorbidities, and antiplatelet or anticoagulant use were similar between the intervention and control groups (Table 1). Between-group similarity was also noted in the presence of juxta-papillary diverticulum, the maximum size of CBD stones, and the distribution of papilla types. Transpancreatic precut sphincterotomy was performed in two patients, one from each group. All patients who had immediate post-EST bleeding achieved successful endoscopic hemostasis by epinephrine injection or heater probe coagulation. No patient received a metal biliary stent for hemostasis.

Table 1.

Baseline characteristics of the intervention and control groups.

N = 120	Intervention group(n = 60)	Control group(n = 60)	p Value
Age (years old, mean ± SD)	63.5 ± 15.5	65.4 ± 15.9	0.506
Sex (M:F)	27:33	31:29	0.584
Blood test
Hemoglobin (g/dL, mean ± SD)	12.83 ± 1.83	13.0 ± 1.91	0.563
WBC (10³/μL, mean ± SD)	8536 ± 3963	9533 ± 4663	0.210
Platelet (10³/μL, mean ± SD)	217.3 ± 99.0	228.7 ± 77.4	0.482
PT-INR (mean ± SD)	1.15 ± 0.12	1.13 ± 0.08	0.222
APTT (mean ± SD)	32.94 ± 3.35	33.32 ± 4.22	0.585
Total bilirubin (mg/dL, mean ± SD)	4.08 ± 2.75	3.55 ± 2.50	0.271
Serum creatinine (mg/dL, mean ± SD)	0.95 ± 0.34	0.98 ± 0.57	0.698
Comorbidities
Use of antiplatelet (%)	8 (13.3)	5 (8.3)	0.558
Use of anticoagulant (%)	1 (1.6)	2 (3.3)	0.999
Coronary artery disease (%)	8 (13.3)	6 (10)	0.777
Cirrhosis (%)	2 (3.3)	0	0.496
ESRD (%)	0	0	0.999
Biliary pancreatitis (%)	11 (18.3)	15 (25)	0.507
Fever >38°C (%)	13 (21.6)	10 (16.6)	0.643
SIRS (%)	16 (26.6)	14 (23.3)	0.833
ERCP-related factors
Previous ERBD for antiplatelet or anticoagulant discontinuation	8 (13.3)	6 (10)	0.777
Juxta-diverticulum (%)	18 (30)	18 (30)	0.999
Stone size (largest, mm, mean ± SD)	6.5 ± 3.5	5.5 ± 3.1	0.105
Papilla type (I:II:III:IV)	47:3:10:0	48:3:8:1	0.935
Transpancreatic precut sphincterotomy	1 (1.6)	1 (1.6)	0.999

APTT, activated partial thromboplastin time; ERBD, endoscopic retrograde biliary drainage; ERCP, endoscopic retrograde cholangiopancreatography; ESRD, end-stage renal disease; PT-INR, prothrombin time-international normalized ratio; SD, standard deviation; SIRS, systemic inflammatory response syndrome; WBC, white blood cell.

Five patients in the control group (4.1%) reported tarry stools after ERCP and received endoscopic hemostasis, whereas no patient in the intervention group had delayed post-EST bleeding. Active oozing from major papilla wounds occurred during endoscopy, and hemostasis was achieved by epinephrine injection and heater probe coagulation. Kaplan–Meier survival curve analysis revealed that freedom from delayed post-EST bleeding within 14 days was longer in the intervention group than in the control group (p = 0.023; Figure 3). The incidence rate of delayed post-EST bleeding was lower in the intervention group than in the control group (0% vs 8.3%; p = 0.029; Table 2). The risk difference was 0% (0/60) in the intervention group versus 8.33% (5/60) in the control group, yielding a risk difference of −8.33% favoring intervention. The number needed to treat was 1/0.0833 = 12 patients. To address 0 events in the intervention group in relative risk estimation, we applied the Newcombe–Wilson method. The relative risk for the intervention group was 0.09 (95% confidence interval (CI): 0.006–0.18; p = 0.03).

Figure 3.

Kaplan–Meier survival curves depicting freedom from delayed bleeding within 14 days after endoscopic sphincterotomy.

Table 2.

Outcomes of biliary endoscopic sphincterotomy in the intervention and control groups.

N = 120	Intervention group(n = 60)	Control group(n = 60)	p Value
Total procedure time (minutes, mean ± SD)	19.8 ± 11.5	20.0 ± 13.7	0.926
Intraprocedural bleeding (%)	6 (10)	4 (6.6)	0.509
Delayed post-EST bleeding (%)^a	0	5 (8.3)	0.029
Post-EST total bilirubin, day 2 (mg/dL, mean ± SD)	1.92 ± 2.35	1.66 ± 1.46	0.475
Decreased total bilirubin, day 2 (mg/dL, mean ± SD)	2.16 ± 1.92	1.89 ± 1.74	0.414
Post-EST Hb, day 2 (g/dL, mean ± SD)	12.19 ± 1.64	11.87 ± 1.65	0.293
Decreased Hb, day 2 (g/dL, mean ± SD)	0.63 ± 0.86	1.15 ± 1.11	0.006
Melena or tarry stool after ERCP	0	6 (10)	0.012
Significant blood loss (Hb loss >2 g/dL)	1 (1.6)	10 (16.6)	0.004
Post-ERCP pancreatitis (%)	2 (3.3)	4 (6.6)	0.679
Post-ERCP cholangitis (%)	2 (3.3)	2 (3.3)	0.999
Incomplete stone removal, s/p biliary stent (%)^b	8 (13.3)	7 (11.6)	0.999
In need of transcatheter arterial embolization/surgery	0	0	0.999
Severe adverse event
Bowel perforation	0	0	0.999
All-cause mortality	0	0	0.999

One-tailed test was performed for the primary outcome.

All patients with incomplete CBD stone removal received a plastic double pigtail biliary stent (Zimmon Biliary Stent Set, 7 Fr, 7 cm; Cook Medical, Bloomington, IN, USA).

CBD, common bile duct; ERCP, endoscopic retrograde cholangiopancreatography; EST, endoscopic sphincterotomy; Hb, hemoglobin; SD, standard deviation.

On post-ERCP day 2, hemoglobin loss was significantly lower in the intervention group than in the control group (0.63 ± 0.86 vs 1.15 ± 1.11 g/dL; p = 0.006; Table 2). In addition, the incidence rate of substantial blood loss (hemoglobin loss >2 g/dL) was significantly lower in the intervention group than in the control group (1.6% vs 16.6%; p = 0.004). Notably, all 5 patients who had delayed post-EST bleeding were among the 11 who had a hemoglobin loss of >2 g/dL. No significant between-group difference was observed in total bilirubin reduction, PEP incidence, or cholangitis incidence. No patients required transcatheter arterial embolization or surgery. Moreover, no cases of bowel perforation or mortality were reported.

Logistic regression was performed to identify key risk factors for substantial blood loss (Table 3). Univariate analysis revealed that topical TXA and sucralfate application was associated with a reduced risk of substantial blood loss (odds ratio: 0.08; 95% CI: 0.01–0.68; p = 0.021). Multivariate analysis confirmed that topical TXA and sucralfate application was independently associated with a reduced risk of substantial blood loss on post-EST day 2 (odds ratio: 0.07; 95% CI: 0.008–0.62; p = 0.017).

Table 3.

Risk factors for substantial blood loss on the day after endoscopic sphincterotomy (hemoglobin loss >2 g/dL).

N = 120	Univariate logistic regression analysis		Multivariate logistic regression analysis
N = 120	OR (95% CI)	p	OR (95% CI)	p
Characteristics
Age >65 y/o	1.77 (0.50–6.16)	0.368
Sex (male)	1.99 (0.55–7.19)	0.294
WBC >12,000/μL	0.71 (0.17–2.90)	0.637
Platelet count <1,50,000/μL	1.20 (0.24–5.96)	0.802	1.82 (0.28–11.55)	0.525
PT-INR >1.2	1.72 (0.20–14.37)	0.646	1.12 (0.10–11.77)	0.921
APTT >34	2.40 (0.68–8.39)	0.171	3.07 (0.73–12.87)	0.124
Maximal stone size	1.50 (0.29–7.73)	0.624
Stone >1 cm	1.29 (0.25–6.53)	0.757	2.23 (0.32–15.22)	0.412
Comorbidity
Biliary pancreatitis	2.97 (0.36–24.39)	0.310
Use of antiplatelet/anticoagulant agents^a	^a	^a
CKD (creatinine >1.5 mg/dL)	1.45 (0.16–13.06)	0.737	1.29 (0.11–15.19)	0.838
Fever >38°C	1.07 (0.21–5.34)	0.931
SIRS	0.54 (0.14–2.02)	0.367
Operation
Intraoperation bleeding	1.11 (0.12–0.96)	0.924	1.26 (0.09–16.44)	0.860
Treatment
TXA/sucralfate spray (+)	0.08 (0.01–0.68)	0.021	0.07 (0.008–0.62)	0.017

No patient with a history of cardiovascular disease or regular use of antiplatelets or anticoagulants exhibited a hemoglobin loss of >2 g/dL.

APTT, activated partial thromboplastin time; CI, confidence interval; CKD, chronic kidney disease; OR, odds ratio; PT-INR, prothrombin time-international normalized ratio; SIRS, systemic inflammatory response syndrome; TXA, tranexamic acid; WBC, white blood cell.

Discussion

To the best of our knowledge, this study is the first to evaluate the efficacy of hemostatic powders in preventing delayed post-EST bleeding. Topical TXA and sucralfate application not only prolonged the duration of freedom from delayed post-EST bleeding but also reduced the risks of delayed bleeding, hemoglobin loss, and substantial blood loss. The small amount of powder applied to the post-EST wound did not increase PEP risk or hinder total bilirubin reduction, reflecting a strong safety profile with no severe side effects.

Despite history and clinical evidence supporting the efficacy of TXA, certain misconceptions persist. Large-scale trials have demonstrated the efficacy of TXA in managing bleeding in various organs, except the gastrointestinal tract.^9,24 Although systemic administration of TXA does not prevent gastrointestinal bleeding or associated mortality, pharmacodynamic analyses suggest that local administration of TXA exerts a strong hemostatic effect.^25,26 A study reported that administering TXA solution through a nasogastric tube to a patient with upper gastrointestinal hemorrhage conferred no additional benefit.²⁷ By contrast, a clinical trial revealed that intravenous plus nasogastric TXA infusion reduced the need for urgent endoscopy, highlighting potential benefits of nasogastric TXA delivery.²⁸ The inconsistency may be attributable to the free-flow delivery of liquid TXA. Precise application of TXA powder, which adheres directly to the bleeding site, yields favorable outcomes.¹¹ In the present study, topical TXA application on the post-EST wound effectively reduced the risks of delayed bleeding and hemoglobin loss after the procedure.

Sucralfate rapidly interacts with duodenal mucosal fluid, forming a protective mucosal barrier.²⁹ It accelerates wound healing by binding to epidermal growth factors and stimulating epithelial proliferation.³⁰ Research has highlighted the advantages of sucralfate in the treatment of gastrointestinal ulcers, underscoring its potential to promote healing by increasing the bioavailability of growth factors and prostaglandins and reducing the production of reactive oxygen species.³¹ The barrier formed by sucralfate shields the post-EST wound from gastric acid interference.³²

Endoscopists have consistently focused on reducing the risk of post-EST bleeding, which has led to major advancements in sphincterotomy. Factors such as incision direction and electrocautery settings strongly influence outcomes. Sphincterotomy along the 11 to 1 O’clock axis reduces the risk of post-EST bleeding by avoiding regions with an increased arterial concentration.³³ Although the pure cut mode in EST is associated with an increased risk of intraprocedural bleeding, the effects of electrocautery settings on delayed post-EST bleeding remain unclear.³⁴

Pharmacologic strategies for preventing delayed bleeding remain inadequate. Although local injection of diluted epinephrine can control intraprocedural bleeding, its short duration of action does not ensure long-term prevention of delayed bleeding.³⁵ Similarly, oral prophylactic proton pump inhibitors exhibit limited efficacy in preventing delayed post-EST bleeding. A clinical trial reported no significant efficacy of proton pump inhibitors in preventing post-EST bleeding.²² By contrast, the present study revealed that combining TXA with sucralfate prevented delayed post-EST bleeding.

This study has several limitations. First, its single-center design and small sample size may limit the generalizability of the findings. Although randomization mitigated some of the effects of study design and sample size, large-scale studies are required for further validation. Second, delayed post-EST bleeding occurred in only five patients (4.1%), which precluded extensive subgroup and multivariate Cox regression analyses. To address this limitation, an analysis was performed in 11 patients (9.1%) who had a hemoglobin loss of >2 g/dL. In addition, multivariate logistic analyses were performed to adjust for potential confounders. Third, during their spraying, some drug powders may remain in the delivery catheter, but the amount is usually small (<0.1 g) and can be ignored. Because this study sought to combine the hemostatic effect of TXA and the wound protection effect of sucralfate, the individual contributions of TXA and sucralfate could not be distinguished. Fourth, this study was not a double-blinded trial. To minimize bias, we ensured that the endoscopists were unaware of group allocation before immediate bleeding was stopped through endoscopic hemostasis. Notably, patients who reported immediate bleeding were successfully managed, and the incidence of immediate bleeding was similar between the two groups. Furthermore, the care provider at the ward was unaware of group allocation, which ensured a low risk of bias. Fifth, none of the enrolled patients had ESRD, which raises concerns regarding the applicability of our findings to patients with ESRD. Further research is required to evaluate the efficacy of TXA and sucralfate application in preventing delayed bleeding in patients with ESRD. Similarly, patients who continued their antiplatelet or anticoagulant therapy were excluded from this study. Thus, additional studies are required to determine whether topical TXA and sucralfate application exerts protective effects in antiplatelet or anticoagulant users. Finally, the duration for which the drug powders remained adhered to the post-EST wound was not determined. All patients remained nil per os for 6 h after ERCP, after which they switched to a clear liquid diet and then gradually to a regular diet. Whether oral intake and constant flow of gastric, biliary, and pancreatic secretions influence the retention of drug powders remains unclear. Future studies should determine the duration of drug powder retention.

In conclusion, topical TXA and sucralfate powder application significantly prolongs freedom from delayed post-EST bleeding and potentially reduces the risks of delayed bleeding and hemoglobin loss after EST. This prophylactic approach appears to be a safe and effective hemostatic strategy with no major side effects. Additional large-scale, multicenter studies are required to validate and expand these findings.

Supplemental Material

sj-docx-1-tag-10.1177_17562848261438597 – Supplemental material for Topical tranexamic acid and sucralfate prevent delayed bleeding after endoscopic sphincterotomy: a randomized controlled trial (with video)

Supplemental material, sj-docx-1-tag-10.1177_17562848261438597 for Topical tranexamic acid and sucralfate prevent delayed bleeding after endoscopic sphincterotomy: a randomized controlled trial (with video) by Hsueh-Chien Chiang, Jui-Wen Kang, Wei-Lun Chang, Tzu-Ling Kuo, Chien-Ming Chiang, Juei-Seng Wu, Po-Jun Chen, Chiao-Hsiung Chuang, Chiung-Yu Chen, Xi-Zhang Lin and Meng-Ying Lin in Therapeutic Advances in Gastroenterology

Footnotes

Acknowledgements

This manuscript was edited by Wallace Academic Editing.

Declarations

ORCID iDs

Hsueh-Chien Chiang

Chiao-Hsiung Chuang

Meng-Ying Lin

Supplemental material

Supplemental material for this article is available online.

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