Trial reportGut2025
Multicentre randomised controlled trial of a self-assembling haemostatic gel to prevent delayed bleeding following endoscopic mucosal resection (PURPLE Trial).
Trial report in Gut, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Definition, analysis, reporting, and interpretation of perioperative bleeding in randomized controlled trials: a methodological systematic review.Perioperative medicine (London, England) · 2026Review
- Tranexamic Acid Versus Epinephrine as Submucosal Injectate During Endoscopic Mucosal Resection of Large Colorectal Lesions: A Randomized Controlled Trial.Journal of clinical medicine · 2026Article
- Use of a Novel Self-assembling Peptide Gel for Prevention of Bleeding After Endoscopic Mucosal Resection of Large Nonpedunculated Sessile Colorectal Polyps: A Case-Control Study.Gastro hep advances · 2026Article
- Recent Advances in Endoscopic Submucosal Dissection for Gastric Cancer: Focusing on Expanded Indications and Technological Innovations.Journal of gastric cancer · 2026Review
- Self-assembling peptide hydrogel prevents esophageal stenosis after endoscopic submucosal dissection for esophageal squamous cell carcinoma: Multicenter prospective study.Endoscopy international open · 2026Article
- Octreotide for prevention of delayed bleeding after endoscopic mucosal resection for large superficial non-ampullary duodenal tumors.Endoscopy international open · 2026Article
- Hemostasis: Role of PuraStatWorld journal of gastrointestinal endoscopy · 2025Article
Corrections and comments
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Authors and funding
31 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProphylactic application of a haemostatic gel to the resection field may be an easy way to prevent delayed bleeding, a frequent complication after endoscopic mucosal resection (EMR).
objectiveWe aimed to evaluate if the prophylactic application of a haemostatic gel to the resection field directly after EMR can reduce the rate of clinically significant delayed bleeding events.
designWe conducted a prospective randomised trial of patients undergoing hot-snare EMR of flat lesions in the duodenum (≥10 mm) and colorectum (≥20 mm) at 15 German centres. Prophylactic clip closure was not allowed, but selective clipping or coagulation could be used prior to randomisation to treat intraprocedural bleeding or for prophylactic closure of visible vessels. Patients were randomised to haemostatic gel application or no prophylaxis. The primary endpoint was delayed bleeding within 30 days.
resultsThe trial was stopped early due to futility after an interim analysis. The primary endpoint was analysed in 232 patients (208 colorectal, 26 duodenal). Both groups were comparable in age, sex, comorbidities and lesion characteristics. Preventive measures, such as selective clipping or coagulation, were applied prior to randomisation in 51.9% of cases, with no difference between groups. Delayed bleeding occurred in 14 cases (11.7%; 95% CI 7.1% to 18.6%) after Purastat and in 7 cases (6.3%; 95% CI 3.1% to 12.3%) in the control group (p=0.227), with no difference between colorectal and duodenal subgroups.
conclusionThe application of a haemostatic gel following EMR of large flat lesions in the duodenum and colorectum does not reduce the rate of delayed bleeding.
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