The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)
Ontology highlight
ABSTRACT:
DISEASE(S): Colonic Polyps
PROVIDER: 9027 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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This study is suggested to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure.
Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement, undifferentiated, free margin less than 1 mm), a surgical resection is performed.
All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with biopsies):
* For complete resection, an endoscopic control was performed at 1 year.
* For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic control was performed at 1 year.
At one year, patient with incomplete resection have a surgical resection.
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Primary outcome(s): 1.The average time required for hemostasis by hemostatic forceps in DRI is shorter than that in WLI. 2.The easiness of hemostasis is better in DRI than in WLI. 3. The psychological stress for hemostasis in DRI is lower than that in WLI.
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Project description:F1 hybrids can outperform their parents in yield and vegetative biomass, features of hybrid vigor which form the basis of the hybrid seed industry. The yield advantage of the F1 is lost in the F2 and subsequent generations. In Arabidopsis, from F2 plants which have a F1 –like phenotype, we have by recurrent selection produced pure breeding F5/F6 lines “Hybrid Mimics”, in which the characteristics of the F1 Hybrid are stabilized. These Hybrid Mimic lines, like the F1 Hybrid, have larger leaves than the parent plant, the leaves having increased photosynthetic cell numbers, and in some lines increased size of cells, suggesting an increased supply of photosynthate. A comparison of the differentially expressed genes in the F1 Hybrid with those of eight Hybrid Mimic lines has identified metabolic pathways altered in both; these pathways include down regulation of defense response pathways and altered abiotic response pathways. F6 Hybrid Mimic lines are mostly homozygous at each locus in the genome yet retain the large F1-like phenotype. Many alleles in the F6 plants, when they are homozygous, have expression levels different to the level in the parent. We consider this altered expression to be a consequence of trans-regulation of genes from one parent by genes from the other parent. Transregulation could also arise from epigenetic modifications in the F1. The pure breeding Hybrid Mimics have been valuable in probing the mechanisms of hybrid vigor and may also prove to be useful hybrid vigor equivalents in agriculture.
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Project description:F1 hybrids can outperform their parents in yield and vegetative biomass, features of hybrid vigor which form the basis of the hybrid seed industry. The yield advantage of the F1 is lost in the F2 and subsequent generations. In Arabidopsis, from F2 plants which have a F1 –like phenotype, we have by recurrent selection produced pure breeding F5/F6 lines “Hybrid Mimics”, in which the characteristics of the F1 Hybrid are stabilized. These Hybrid Mimic lines, like the F1 Hybrid, have larger leaves than the parent plant, the leaves having increased photosynthetic cell numbers, and in some lines increased size of cells, suggesting an increased supply of photosynthate. A comparison of the differentially expressed genes in the F1 Hybrid with those of eight Hybrid Mimic lines has identified metabolic pathways altered in both; these pathways include down regulation of defense response pathways and altered abiotic response pathways. F6 Hybrid Mimic lines are mostly homozygous at each locus in the genome yet retain the large F1-like phenotype. Many alleles in the F6 plants, when they are homozygous, have expression levels different to the level in the parent. We consider this altered expression to be a consequence of trans-regulation of genes from one parent by genes from the other parent. Transregulation could also arise from epigenetic modifications in the F1. The pure breeding Hybrid Mimics have been valuable in probing the mechanisms of hybrid vigor and may also prove to be useful hybrid vigor equivalents in agriculture.
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Project description:Interventions: For bleeding during endoscopic submucosal dissection, an oral rehydration jelly is injected to identify the bleeding site. There is no upper limit to the number and amount of jelly injections.
For bleeding during endoscopic submucosal dissection, an oral rehydration jelly is injected to identify the bleeding site. There is no upper limit to the number and amount of jelly injections.
Primary outcome(s): In Phase I, OS-1 jelly was used to improve the field of view and evaluate safety when hemostasis occurred. In Phase II, the time taken to identify the bleeding site in the normal group and jelly combination group.
Study Design: Parallel Randomized
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