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Status unknownNCT02833103Updated Jul 14, 2016

Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

A Phase 4 interventional study of Danshu Capsules and Pinaverium Bromide in Sphincter of Oddi Dysfunction, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2016-07-14.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sphincter of Oddi Dysfunction

Keywords

  • Pinaverium Bromide
  • cholecystectomy
  • Sphincter of Oddi Dysfunction
03

In context

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (estimated)

Study arms

  • Experimental
    Pinaverium Bromide group

    Able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.

    Drug: Pinaverium Bromide

  • 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

Interventions

  • DrugDanshu Capsules

    Danshu Capsules (0.9g potid/day) for three months by oral

    Also known as: Danshu softgel Capsules

  • DrugPinaverium Bromide

    Pinaverium Bromide (100mg potid/day) for three months by oral

    Also known as: Dicetel

06

What researchers measure

Primary outcomes

  1. Efficacy Evaluation of Reduction in Abdominal Pain Scores，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

    Time frame: Change From Baseline to 3 Months After Medication

Secondary outcomes

  1. Changes in the Common Bile Duct (CBD) Diameter Measured by Ultrasound B Once a Month

    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)

    Time frame: 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

    * 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)

    Time frame: 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

    The number of patients presenting the symptoms of diarrhea will be calculated at the time of enrollment (baseline) and 3 months after treatment respectively.

    Time frame: From Baseline to 3 Months After Medication

Other outcomes

  1. Number of Participants With Treatment-Related Adverse Events as Assessed by Researchers or Doctors Through Study Completion

    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

    Time frame: Through Study Completion, An Average of 1 Year

07

Study locations

1 of 1 sites recruiting
  • Zhang Yong
    Shanghai, Shanghai 200092, China
    • Yong Zhang, MD,PhD · Contact · +86 21 25078999-7905
    • Yong Zhang, MD,PhD · Principal investigator
    • Houbao Liu, MD,PhD · Principal investigator
    • Tao Suo, MD,PhD · Sub investigator
    • Jian Wang, MD,PhD · Principal investigator
    • Wei Chen, MD,PhD · Sub investigator
    • Yajin Chen, MD,PhD · Principal investigator
    • Yunyao Xu, MD,PhD · Sub investigator
    • Xiujun Cai, MD,PhD · Principal investigator
    • Xiao Liang, MD,PhD · Sub investigator
    • Lin Ji, MD,PhD · Sub investigator
    • Jianying Lou, MD,PhD · Principal investigator
    • Ji Wang, MD,PhD · Sub investigator
    • Xitai Sun, MD,PhD · Principal investigator
    • Xiaodong Shan, MD,PhD · Sub investigator
    • Yu He, MD,PhD · Principal investigator
    • Dajiang Li, MD,PhD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Cotton PB, Durkalski V, Romagnuolo J, Pauls Q, Fogel E, Tarnasky P, Aliperti G, Freeman M, Kozarek R, Jamidar P, Wilcox M, Serrano J, Brawman-Mintzer O, Elta G, Mauldin P, Thornhill A, Hawes R, Wood-Williams A, Orrell K, Drossman D, Robuck P. Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA. 2014 May;311(20):2101-9. doi: 10.1001/jama.2014.5220. PubMed 24867013 ↗
  • Vitton V, Ezzedine S, Gonzalez JM, Gasmi M, Grimaud JC, Barthet M. Medical treatment for sphincter of oddi dysfunction: can it replace endoscopic sphincterotomy? World J Gastroenterol. 2012 Apr 14;18(14):1610-5. doi: 10.3748/wjg.v18.i14.1610. PubMed 22529689 ↗
  • Okoro N, Patel A, Goldstein M, Narahari N, Cai Q. Ursodeoxycholic acid treatment for patients with postcholecystectomy pain and bile microlithiasis. Gastrointest Endosc. 2008 Jul;68(1):69-74. doi: 10.1016/j.gie.2007.09.046. PubMed 18577477 ↗
  • Kalaitzakis E, Ambrose T, Phillips-Hughes J, Collier J, Chapman RW. Management of patients with biliary sphincter of Oddi disorder without sphincter of Oddi manometry. BMC Gastroenterol. 2010 Oct 22;10:124. doi: 10.1186/1471-230X-10-124. PubMed 20969779 ↗
  • Behar J, Corazziari E, Guelrud M, Hogan W, Sherman S, Toouli J. Functional gallbladder and sphincter of oddi disorders. Gastroenterology. 2006 Apr;130(5):1498-509. doi: 10.1053/j.gastro.2005.11.063. PubMed 16678563 ↗
  • Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available. PubMed 16678553 ↗
  • Hernando N, Gisler SM, Reining SC, Deliot N, Capuano P, Biber J, Murer H. NaPi-IIa interacting proteins and regulation of renal reabsorption of phosphate. Urol Res. 2010 Aug;38(4):271-6. doi: 10.1007/s00240-010-0304-3. Epub 2010 Jul 28. PubMed 20665015 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02833103
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Zhaohui Tang (the chief surgeon of the department of General Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Jul 14, 2016
Start date
Jul 2016
Primary completion
Feb 2018 (estimated)
Completion
Feb 2018 (estimated)
Last update
Jul 14, 2016

Study contacts

Zhaohui Tang, MD,PhD
Contact
tangzhaohui@yahoo.com
+86 021 25078999-7905
Zhaohui Tang, MD,PhD
principal investigator · Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
Zhiwei Quan, MD,PhD
study chair · Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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