Application of Pinaverium Bromide in the Treatment of Patients With Post-cholecystectomy Sphincter of Oddi Dysfunction (SOD): A Randomized, Controlled and Multicenter Clinical Study
试验速览
- 阶段
- 4 期
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Efficacy Evaluation of Reduction in Abdominal Pain Scores，Change From Baseline to 3 Months After Medication
研究概览
简要总结
Sphincter of Oddi dysfunction (SOD) refers to biliary kinetic abnormality of the sphincter of Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile duct (CBD) dilation or onset of pancreatitis. Pain caused by SOD affects the quality of life (QoL).The primary objective of this trial is to evaluate the efficacy of relieving abdominal pain of Pinaverium Bromide in medication therapy for patients with post-cholecystectomy SOD.
详细描述
1.1 Background (I)
1.1.1 10%~50% of the patients who previously underwent cholecystectomy experience recurrent abdominal pain with or without diarrhea, abdominal distention, enzymatic changes, etc., and sphincter of Oddi dysfunction (SOD) accounts for about 13% of such cases;
1.1.2 Sphincter of Oddi dysfunction (SOD):
- It refers to biliary kinetic abnormality of the sphincter of Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile duct (CBD) dilation or onset of pancreatitis.
- Pain caused by SOD affects the quality of life (QoL).
1.1.3 The diagnosis of SOD is still being disputed, and there has been no optimal solution so far.
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
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chief complaint of upper right abdominal pain following LC (within 2 weeks to 6 months) at a hospital visit, but not a pain caused by surgical incision, lasting 3 to 5 minutes each time, without a history of other biliary tract operation
- •No presence of intestinal obstruction as evidenced by plain abdominal X-ray, with peptic ulcer and duodenal diverticulum ruled out through barium meal examination or gastroscopy
- •No other obvious abnormalities as evidenced by abdominal ultrasound B and MRCP, except for bile duct dilation
- •Patients with biliary-type sphincter of Oddi dysfunction (SOD) who are classified as SOD type II (biliary-type abdominal pain accompanied by hepatic enzyme elevation or common bile duct (CBD) dilation) and SOD type III (only biliary-type abdominal pain) according to Geenen-Hogan classification criteria
排除标准
- •Postoperative biliary calculi, benign biliary stenosis, bile duct infection, overlong residual cystic duct (> 0.5cm), biliary tumors, etc.
- •Peptic ulcer, duodenal diverticulum
- •Pancreatitis, pancreatic-type SOD
- •Adhesive intestinal obstruction
- •Postoperative irritable bowel syndrome (IBS)
- •A history of abdominal operation or other surgery
- •Pregnant and lactating women
- •Use of other drugs from one week after LC to enrollment, including antispasmodic drugs, analgesics, choleretic agents, calcium ion antagonists and GI motility drugs
- •A history of allergy to Pinaverium Bromide / Danshu Tablets
研究组 & 干预措施
Pinaverium Bromide group
Able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.
干预措施: Pinaverium Bromide (Drug)
Danshu group
Contains the active pharmaceutical ingredient (API) and has the effects of fighting infection, alleviating pain, promoting bile secretion and lifting muscle spasms; literature showed that Danshu Capsules effectively improved the symptoms of biliary disorders, such as pain, nausea and abdominal distension.
干预措施: Danshu Capsules (Drug)
结局指标
主要结局
Efficacy Evaluation of Reduction in Abdominal Pain Scores，Change From Baseline to 3 Months After Medication
时间窗: Change From Baseline to 3 Months After Medication
abdominal pain scores (baseline vs. 3 months after treatment) * Abdominal pain score based on main symptom: Degree of pain in point（0 - no pain \[0 point\]；1\~3 - mild pain \[1 point\]；4\~6 moderate pain \[2 point\]\]；7\~10 - severe pain \[3 point\]）、Frequency in times/week (No episodes\[0 point\]；1 time/week\[1 point\]；2 times/week\[2 point\]; 3 times/week\[3 point\])、Duration in days/week(No episodes\[0 point\]；\< 1 day/week\[1 point\]；1-2days/week\[2 points\]；≥ 3days/week\[3 points\]) * The sum of the scores for the above three items is the total score for abdominal pain. * Efficacy evaluation: reduction in abdominal pain score, as compared with the baseline * = 100%: complete remission (CR)；60%\~99%: significant remission (SR)；30% \~ 59%: partial remission (PR)；0% \~ 29%: no response (NR) * Treatment response = CR + SR * Treatment response rate = (CR + SR) / the total number of patients
次要结局
- Changes in the Common Bile Duct (CBD) Diameter Measured by Ultrasound B Once a Month(Once a Month, Four Times Totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment))
- Efficacy of Lowering Liver Enzymes as Assessed by Laboratory Test Once a Month(Once a Month, Four Times Totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment))
- Number of Participants With Treatment-Related Diarrhea,Change From Baseline to 3 Months After Medication(From Baseline to 3 Months After Medication)
研究者
Zhaohui Tang
the chief surgeon of the department of General Surgery
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine