Prospective Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy of Octreotide in Prevention of Salivary Fistulae After Post Radiation Salvage Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- elimination of post-radiation salivary fistulae
研究概览
简要总结
Salivary fistulae have been the bane of surgical salvage in the era of primary chemoradiation for head and neck (H&N) cancers. The "blame"of prior chemoradiation tissue damage encouraged compensatory surgical techniques that focused on the insertion of non-irradiated tissue into the field. This study emphasizes a paradigm shift in the understanding and treatment of pharyngocutaneous fistulae. The detrimental effects of salivary enzymes on tissue healing and surgical anastomoses are addressed and novel treatment strategy is outlined.
详细描述
After signing an informed consent form, patients scheduled for total laryngectomy or for composite resections for oral/pharyngeal/laryngeal malignant tumors, will be randomly divided into two groups of about ten in each. The control group will receive a placebo while the study group will receive octreotide. All involved in the care of the patients and the patients themselves will be blinded to the drug given. The rest of the treatment will be equal in both groups and will adhere to the current departmental protocols in Otolaryngology/Oral-Maxillofacial Surgery.
The studied drug (Octreotide 100 mcg s/c) or placebo will be administered in the evening prior to surgery and subsequently for two weeks on a thrice daily basis.
Both groups will remain in hospital postoperatively for a minimum two week period (the current common practice). In addition to daily wound assessments, including daily grading of the pharyngocutaneous fistulae (using our grading system), the patients will also be evaluated for:
Serology:
- Complete blood count and biochemistry including CRP and amylase will be assessed every 3 days.
- GlucoChecks will be performed daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemoradiation
- •Total laryngectomy
- •Composite resections for oral/pharyngeal/laryngeal malignant tumors
排除标准
- •Pregnancy
- •Patients with malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means
- •Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/d
研究组 & 干预措施
octreotide treatment
The studied drug Octreotide 100 mcg will be administered I.V in the evening prior to surgery and for two weeks on a thrice daily basis.
干预措施: octreotide (Drug)
placebo treatment
plasebo will be administrated I.V in the evening prior to surgery and two weeks on a thrice daily basis
干预措施: placebo (Other)
结局指标
主要结局
elimination of post-radiation salivary fistulae
时间窗: up to 7 days after the surgery
yes/no fistulae formation
次要结局
- saliva secretion rate(up 14 days after the surgery)
- pain evaluation(up to 14 days after the surgery)