Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction
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Mücərrəd
Təsvir
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.
- The diagnosis of SOD is largely based on clinical judgment
- The gold standards ERCP and SOM are invasive diagnostic criteria
1.2 Background (II)
1.2.1 If biliary-type abdominal pain after cholecystectomy is considered as SOD, most of the patients are classified as SOD II and SOD III according to Rome III Criteria-modified.
Biliary SOD Type I: moderate or severe biliary-type abdominal pain; transient ALT / AST/ALP elevation > 2ULN; CBD dilation > 8mm as evidenced by ultrasound or other non-invasive examination Type II: biliary-type abdominal pain; One or two of above items Type III:only biliary-type abdominal pain
1.3 Background (III)
1.3.1 Treatment of SOD is being disputed: currently, the main method is to relax sphincter of Oddi (SO).
- Medications: antispasmodic drugs, nitrates, calcium ion antagonists, modulators of gastrointestinal (GI) motility
- EST(endoscopic sphincterotomy): postoperative complications and mortality
1.3.2 EST is not well effective in the treatment of SOD type II and type III, which are mostly caused by functional abnormalities
−ASGE guideline 2015 points out that EST is not recommended for patients with SOD type III. Endoscopic stents are not recommended, either.
1.3.3 Danshu Capsules: 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.
1.3.4 Pinaverium Bromide: able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.·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.
Tarixlər
| Son Doğrulandı: | 06/30/2016 |
| İlk təqdim: | 07/03/2016 |
| Təxmini qeydiyyat təqdim edildi: | 07/10/2016 |
| İlk Göndərmə: | 07/13/2016 |
| Son Yeniləmə Göndərildi: | 07/10/2016 |
| Son Yeniləmə Göndərildi: | 07/13/2016 |
| Həqiqi Təhsilin Başlama Tarixi: | 06/30/2016 |
| Təxmini İlkin Tamamlanma Tarixi: | 01/31/2018 |
| Təxmini İşin Tamamlanma Tarixi: | 01/31/2018 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: Danshu group
Drug: Pinaverium Bromide group
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Experimental: Pinaverium Bromide group Able to improve the spasms of SO; literature showed that it treated biliary disorders effectively. | Drug: Pinaverium Bromide group Pinaverium Bromide (100mg potid/day) for three months by oral |
| Active Comparator: 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. | Drug: Danshu group Danshu Capsules (0.9g potid/day) for three months by oral |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Nəticə
İlkin nəticə tədbirləri
1. Efficacy Evaluation of Reduction in Abdominal Pain Scores，Change From Baseline to 3 Months After Medication [Change From Baseline to 3 Months After Medication]
İkincili Nəticə Tədbirləri
1. 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)]
2. 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)]
3. Number of Participants With Treatment-Related Diarrhea,Change From Baseline to 3 Months After Medication [From Baseline to 3 Months After Medication]
Digər nəticə tədbirləri
1. Number of Participants With Treatment-Related Adverse Events as Assessed by Researchers or Doctors Through Study Completion [Through Study Completion, An Average of 1 Year]
