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Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

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ClinicalTrials.gov Identifier: NCT02833103
Recruitment Status : Unknown
Verified July 2016 by Zhaohui Tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Zhaohui Tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sphincter of Oddi Dysfunction Drug: Danshu Capsules Drug: Pinaverium Bromide Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Pinaverium Bromide in the Treatment of Patients With Post-cholecystectomy Sphincter of Oddi Dysfunction (SOD): A Randomized, Controlled and Multicenter Clinical Study
Study Start Date : July 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
Experimental: Pinaverium Bromide group
Able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.
Drug: Pinaverium Bromide
Pinaverium Bromide (100mg potid/day) for three months by oral
Other Name: Dicetel

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 Capsules
Danshu Capsules (0.9g potid/day) for three months by oral
Other Name: Danshu softgel Capsules




Primary Outcome Measures :
  1. Efficacy Evaluation of Reduction in Abdominal Pain Scores,Change From Baseline to 3 Months After Medication [ Time Frame: 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


Secondary Outcome Measures :
  1. Changes in the Common Bile Duct (CBD) Diameter Measured by Ultrasound B Once a Month [ Time Frame: Once a Month, Four Times Totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment) ]

    Changes in the CBD diameter measured by ultrasound B

    • Each patient is required to abstain from eating for 12 hours and then takes a measurement of the CBD diameter by ultrasound B the next morning
    • The measurement takes places 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 [ Time Frame: Once a Month, Four Times Totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment) ]
    • Changes in hepatic enzyme levels (ALT, AST and ALP)
    • The measurement takes place 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 [ Time Frame: From Baseline to 3 Months After Medication ]
    The number of patients presenting the symptoms of diarrhea will be calculated at the time of enrollment (baseline) and 3 months after treatment respectively.


Other Outcome Measures:
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by Researchers or Doctors Through Study Completion [ Time Frame: Through Study Completion, An Average of 1 Year ]

    Incidence of adverse events (throughout the treatment)

    • The type and number of adverse events will be calculated at the baseline and each visit
    • Inquire about symptoms: rashes, pruritus, acid regurgitation, abdominal distention, diarrhea, etc.
    • Perform the following examinations at the last visit: blood / urine / stool test, liver / kidney function test, ECG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833103


Contacts
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Contact: Zhaohui Tang, MD,PhD +86 021 25078999-7905 tangzhaohui@yahoo.com

Locations
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China, Shanghai
Zhang Yong Recruiting
Shanghai, Shanghai, China, 200092
Contact: Yong Zhang, MD,PhD    +86 21 25078999-7905      
Principal Investigator: Yong Zhang, MD,PhD         
Principal Investigator: Houbao Liu, MD,PhD         
Sub-Investigator: Tao Suo, MD,PhD         
Principal Investigator: Jian Wang, MD,PhD         
Sub-Investigator: Wei Chen, MD,PhD         
Principal Investigator: Yajin Chen, MD,PhD         
Sub-Investigator: Yunyao Xu, MD,PhD         
Principal Investigator: Xiujun Cai, MD,PhD         
Sub-Investigator: Xiao Liang, MD,PhD         
Sub-Investigator: Lin Ji, MD,PhD         
Principal Investigator: Jianying Lou, MD,PhD         
Sub-Investigator: Ji Wang, MD,PhD         
Principal Investigator: Xitai Sun, MD,PhD         
Sub-Investigator: Xiaodong Shan, MD,PhD         
Principal Investigator: Yu He, MD,PhD         
Sub-Investigator: Dajiang Li, MD,PhD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Zhaohui Tang, MD,PhD Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
Study Chair: Zhiwei Quan, MD,PhD Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University

Publications:

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Responsible Party: Zhaohui Tang, the chief surgeon of the department of General Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02833103     History of Changes
Other Study ID Numbers: XH-16-015
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zhaohui Tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Pinaverium Bromide
cholecystectomy
Sphincter of Oddi Dysfunction

Additional relevant MeSH terms:
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Sphincter of Oddi Dysfunction
Postcholecystectomy Syndrome
Biliary Dyskinesia
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Bromides
Pinaverium
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents