D12.0 D12.1 D12.2 D12.3 D12.4 D12.5 D12.6 D12.7 D12.8
Conditions
Interventions
Group 1: Submucosal injection with glycerosteril ® + indigocarmine (0.032 mg / ml) + adrenaline (1: 100.000) - subsequently polypectomy followed by biopsies of the resection margin
Group 2: Submucosal
Sponsors
Universitätsklinikum Würzburg, Med. Klinik II, Gastroenterologie
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: - patients undergoing diagnostic Ileo colonoscopy - patients undergoing colonoscopy in cancer care - patients with planned polypectomy (polyps known from preliminary examination) - patients with the indication for ablation of sessile (Paris 0-Is) or flat Polypes (Paris 0-IIa) of 8mm to 25mm diameter, performed by using a injection solution (decision is made by the physician) - Good communication with the doctor and all the requirements of the study - Existence of written consent on the day before the investigation
Exclusion criteria
Exclusion criteria: - therapeutic ileo-colonoscopy in cases of serious diseases and interventions in the gastrointestinal tract (bleeding, decompression e.g. in tumor stenosis) - so called emergency endoscopies - patients with chronic inflammatory diseases (Crohn's disease or ulcerative colitis) - serious acute and chronic organ disease requiring treatment (e.g. renal replacement treatment) - Patients with an increased risk of bleeding (e.g., therapeutic anticoagulation with Vit-K antagonists, NOAKs, coagulation disorders), which exclude a polypectomy - the decision is made by the performing physician (for polypectomies are commonly required a platelet count of 50,000 / µl, as well as a pTT 50%) - Drug or alcohol abuse - Pregnancy - Intellectual impairment, which limits the ability to meet all study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (I) The use of a dyed glycerosterol solution (Glycerosteril® 10% with indigocarmine and adrenaline) results in a reduced the rate of incomplete polypectomies (residual cells in the marginal biopsies) in polyps between 8 and 25mm by at least 30%, compared to the standard solution (NaCl with adrenaline). | — |
Secondary
| Measure | Time frame |
|---|---|
| (II) The use of dyed glycerosteril® results in a higher rate of en bloc resections of polyps, up to 25mm, compared to standard the solution (endoscopic and histologic en-boc resection). (III) The polypectomy succeeds more easily due to the stability of submucosal fluid collection and takes less time (subjective assessment of the endoscopist filled in the CRF, time measurement). (IV) Due to the more stable submucosal fluid collection, the rate of acute complications through the polypectomy is no more frequent compared to the standard solution (registration in CRF). | — |
Countries
Germany
Contacts
Public ContactMarkus Brand
Universitätsklinikum Würzburg, Med. Klinik II, Gastroenterologie
Outcome results
None listed