Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- change in disease severity scores, as assessed using our three-item symptom scale
研究概览
简要总结
The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.
详细描述
Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are difficult to treat and adversely impact patient quality of life. Various treatments directed at the reduction of blood loss and improvement of other symptoms have been evaluated, with the most encouraging results reported for two methods: endoscopic argon plasma coagulation (APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of sucralfate, a drug believed to enhance the mucosal defense and healing when administered orally or rectally. Adequately powered randomized trials comparing various treatments are lacking, and an optimal management strategy has yet to be determined. To address this issue, we conducted a single-center, randomized, placebo-controlled, double-blind study comparing the efficacy and safety of APC alone and APC in combination with sucralfate administered orally.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radiotherapy due to pelvic tumors completed at least three months prior to enrollment
- •presence of rectal bleeding
- •radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy
- •informed written consent to participate in the study
排除标准
- •history of clinically significant rectal bleeding prior to radiotherapy
- •conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream
- •sucralfate treatment during the two weeks prior to enrollment
- •renal insufficiency (creatinine level ≥2 mg/dl)
- •concurrent chemotherapy
- •concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because of drug interaction)
- •concurrent therapy with oral anticoagulants
研究组 & 干预措施
APC plus oral sucralfate
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks.
干预措施: Sucralfate (Drug)
APC plus placebo
Argon plasma coagulation treatment followed by placebo administration for four weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
change in disease severity scores, as assessed using our three-item symptom scale
时间窗: baseline vs. 16 week
Three-item symptom scale Diarrhea - score 1: 1-3 stools/24 h; 2: 4-6 stools/24 h; 3 \>6 stools/24 h Bleeding - score 0: No blood; 1: Blood on toilet paper or stool; 2: Blood in toilet bowl; 3: Heavy bleeding with clots; 4: Bleeding requiring transfusions Tenesmus/rectal pain - score 0: Absent; 1: Mild tenesmus not requiring any drug; 2: Tenesmus requiring analgesics/antispasmodics; 3: Severe tenesmus requiring everyday use of analgetics/antispasmodics.
次要结局
- change in endoscopic severity score(baseline vs. week 8 and week 16)
- change in disease severity score(baseline vs. week 52)
- complication rate(baseline to 16 weeks)