Dataset Information

Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial.

ABSTRACT: BACKGROUND:Acute variceal bleeding (AVB) requires early therapeutic management by experienced endoscopists that often poses logistical challenges for hospitals. We assessed a different management concept with early application of haemostatic powder-which does not require high endoscopic expertise-added to conventional management in a randomised trial. METHODS:Cirrhotic patients with AVB received standard medical therapy and were randomised to either immediate endoscopy with haemostatic powder application within 2?hours of admission, followed by early elective endoscopy on the next day, that is, within 12-24?hours of admission for definitive treatment (study group) or to early elective endoscopy only (control group). In both groups, failures to achieve clinical haemostasis until the time of early elective endoscopy underwent rescue endoscopy with attempted conventional haemostasis. Primary outcome was endoscopic haemostasis at the elective endoscopy. RESULTS:Of 86 randomised patients with AVB, 5/43 in the study group required rescue endoscopy for failure of controlling spurting bleeding (n=4) after powder application or for early bleeding recurrence in one patient who died before repeating rescue endoscopy. In the control group, 13/43 patients required rescue endoscopic haemostasis for failure of clinical haemostasis (12%vs30%, p=0.034). In the remaining patients, early elective endoscopic haemostasis was achieved in all 38 patients in the study group, while all remaining 30 patients in the control group had fresh gastric blood or (10%) spurting bleeding at early elective endoscopy with successful haemostasis in all of them. Six-week survival was significantly improved in the study group (7%vs30%, p=0.006). CONCLUSION:The new concept of immediate powder application improves early clinical and endoscopic haemostasis. This simplified endoscopic approach may have an impact on early and 6-week survival. TRIAL REGISTRATION NUMBER:NCT03061604.

SUBMITTER: Ibrahim M

PROVIDER: S-EPMC6580783 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial.

Ibrahim Mostafa M El-Mikkawy Ahmed A Abdel Hamid Mohamed M Abdalla Haitham H Lemmers Arnaud A Mostafa Ibrahim I Devière Jacques J

Gut 20180505 5

<h4>Background</h4>Acute variceal bleeding (AVB) requires early therapeutic management by experienced endoscopists that often poses logistical challenges for hospitals. We assessed a different management concept with early application of haemostatic powder-which does not require high endoscopic expertise-added to conventional management in a randomised trial.<h4>Methods</h4>Cirrhotic patients with AVB received standard medical therapy and were randomised to either immediate endoscopy with haemos ...[more]

PMID: 29730601

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Project description:BackgroundPatients with active nonvariceal upper gastrointestinal bleeding (NVUGIB) usually require urgent endoscopic treatment. Standard therapy (ST) using haemoclip + / - epinephrine injection is not always successful. Bipolar haemostatic forceps (HemoStat/Pentax®) are an approved medical device for the treatment of gastrointestinal bleeding. However, their use as a primary endoscopic treatment for active NVUGIB has not yet been proven in a randomized prospective study.MethodsThis is a prospective, randomized, multicentre superiority trial (n ≥ 5). Patients with active NVUGIB will be randomized (1:1) to ST and to experimental therapy (ET) by application of bipolar haemostatic forceps. In the case of failed initial treatment within 15 min, crossover treatment will be attempted first. Rescue treatment (e.g. via over-the-scope-clip) will then be allowed after 30 min. All patients will also receive standard therapy with proton pump inhibitors. Forty-five patients per treatment arm are required to demonstrate an absolute difference of 25.4% with a power of 80% and a significance level of 0.05.DiscussionThe hypothesis of the study is that bipolar haemostatic forceps are superior to ST in terms of successful primary haemostasis and the absence of recurrent bleeding within 30 days (combined endpoint). The 1:1 randomization is also ethically justifiable for this study, as both procedures are approved for the intervention in question. To further increase the safety of the patients in the study, crossover treatment and rescue treatment are planned. The prospective design seems feasible in a reasonable time frame (recruitment period of 12 months), as nonvariceal upper gastrointestinal bleeding is common. Anticoagulants and/or antiplatelet drugs could be an important confounding factor in the statistical analysis that needs to be taken into account and calculated if necessary. In conclusion, this randomized, prospective, multicentre study could make an important contribution to answering the question of whether bipolar haemostatic forceps could be the first-line therapy in the endoscopic treatment of stage Forrest I a + b NVUGIB.Trial registrationClinicalTrials.gov NCT05353062. Registered on April 30 2022.

Project description:BackgroundGastrointestinal bleeding is a rare but severe complication of pancreatic ductal adenocarcinoma.ObjectiveThe purpose of this study was to describe the causes and treatments of non-postoperative gastrointestinal bleeding in patients with pancreatic ductal adenocarcinoma, and explore the parameters associated with therapeutic effectiveness.MethodsThis was a single-centre observational retrospective study (2000-2017) with data collected from the prospectively coded diagnostic hospital's database system including patients with pancreatic ductal adenocarcinoma who had a gastrointestinal bleeding episode. Effectiveness of haemostatic treatment was assessed according to transfusion requirements and immediate and long-term haemostatic efficacy; the latter defined as no bleeding recurrence.ResultsThe population included 72 patients with pancreatic ductal adenocarcinoma who had 94 episodes of gastrointestinal bleeding. The main causes of gastrointestinal bleeding were gastroduodenal tumour invasion (56.4%) and oesophageal variceal bleeding due to left-sided portal hypertension (19.1%). In cases of gastrointestinal bleeding caused by tumour invasion, the main treatment was therapeutic endoscopy (41.5%). Among patients who had gastrointestinal bleeding by tumour invasion treated by endoscopy or radiation therapy, haemostatic immediate efficacy rates were 70.6% and 100%, respectively. Bleeding recurrence rates were 35.3% and 25.0%, for patients treated by endoscopy or radiation therapy, respectively, for a first episode of gastrointestinal bleeding by tumour invasion. Transfusion requirements, before and after treatment, were not different in patients treated by haemostatic radiation therapy for gastrointestinal bleeding by tumour invasion compared to other treatments (odds ratio 0.3, 95% CI (0.06-1.59); p = 0.16). The median survival after all-cause gastrointestinal bleeding was 2.72 months (1.43-4.01).ConclusionGastroduodenal tumour invasion was the main cause of gastrointestinal bleeding in patients with pancreatic ductal adenocarcinoma; haemostatic radiation therapy is a potential interesting option for gastrointestinal bleeding treatment in this context.

Dataset Information

Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial.

Publications

Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial.

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