Carbon Black Tattoo in Colon Cancer
关键词
抽象
描述
Other objectives are:
- to assess intraoperative visibility of carbon black tattoo in the tumor region and surrounding tissues
- to assess microscopic distribution of carbon ink in the layers of the colonic wall and adjacent tissues
- to assess complications related to carbon black tattoo procedure like microscopic fibrosis, micro- or macroscopic scarring, inflammatory reactions
- to assess long-term effects of ink injections on control endoscopies at 6 and 12 months
- to assess dissection time in tattooed-non tattooed lymphatic tissues
日期
| 最后验证: | 01/31/2019 |
| 首次提交: | 10/07/2018 |
| 提交的预估入学人数: | 10/11/2018 |
| 首次发布: | 10/14/2018 |
| 上次提交的更新: | 03/08/2019 |
| 最近更新发布: | 03/11/2019 |
| 实际学习开始日期: | 02/05/2019 |
| 预计主要完成日期: | 02/05/2020 |
| 预计完成日期: | 02/05/2020 |
状况或疾病
干预/治疗
Device: Tattoo arm
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Tattoo arm Tattoo will be placed by endoscopic submucosal injection of carbon black suspension | Device: Tattoo arm Examine the SPOT syringe to verify that the pigment is fully suspended. A 23 or 25 G sclerotherapy needle is recommended for this procedure, attach the syringe and prime with SPOT. After injection catheter is primed, manoeuver with the endoscope for optimal injection position and inject tangentially, at a 30-40˚ angle to the mucosa and create a saline bleb to find the submucosal plane prior to injecting SPOT to reduce risk of intramural injection. Document both the depth of scope and anatomic location of each tattoo and the ink consumption as well. Place injection 2-3 cm distal (downstream) of the area of interest. Use 0.5-0.75 mL per injection site and no more than 8 mL per patient. Place SPOT tattoos in 3-4 quadrants around the lumen to increase likelihood of visualisation. |
| No Intervention: Control arm Tattoo will not be placed but case will follow standard procedure |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Male or female aged 18 years or above undergoing colonoscopy for suspected colonic malignancy - Participant is able to give informed consent for participation in the study - Patient is presumably selected for surgery within 30 days following tattoo injection Exclusion Criteria: - Patients under the age of 18 - Patients unable to give informed consent or ineligible for surgery - Tumor in the coecum dome or in the rectum (<15 cm) - Known allergy to suspension ingredients |
结果
主要结果指标
1. Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity [1 year]
