An interventional study of Pinaverium bromide and Placebo for control group in Chronic Pancreatitis and Pancreatic Duct Stones, sponsored by Yanqing Li. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Yanqing Li · Not applicable, Interventional, and Prevention
Among 46 studies in Pancreatitis, Chronic with a site in China — 15 open to participants now, 19 under way, none of them phase 3. Pancreatitis, Chronic · China.
Among the 46 studies in Pancreatitis, Chronic with a site in China, this one is the 7th largest by planned enrollment of the 19 interventional ones that give a count, is one of 11 that started in 2025, is one of 14 with no phase, reaches primary completion later than 11 of the 18 other live ones, and was the 35th registered.
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
Browse Pancreatitis, Chronic studies →15 of the 46 studies in Pancreatitis, Chronic with a site in China are open now. Recruiting first, the newest first:
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 49 Pancreatitis, Chronic studies recruiting now, 31 (63%) set no upper age limit and 12 (24%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 11 started in 2025.
This study's planned enrollment of 288 is above the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.
Median enrollment 204 across the 19 interventional studies, 359 across the 27 observational. Of the 16 that completed or were terminated, 1 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 46 has an industry lead sponsor. The 10 most frequent:
Yanqing Li is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Yanqing Li has 1 study filed under Pancreatitis, Chronic — fewer than ten, so there is no comparison to draw.
2 of the studies in Pancreatitis, Chronic with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03324698Changhai HospitalThe Natural History of Chronic Pancreatitis | 2026-12-31 |
| NCT07314489Shanghai Changzheng HospitalA Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis | 2026-12-31 |
Among the 46 studies in Pancreatitis, Chronic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study aims to evaluate whether perioperative pinaverium bromide (a calcium antagonist) reduces post-ESWL complications (pancreatitis, abdominal pain, infection) in chronic pancreatitis patients with pancreatic duct stones ≥5mm. A single-center, randomized, double-blind, placebo-controlled design will be used, with 288 participants allocated to either pinaverium bromide (100mg tid) or placebo before and after p-ESWL.
Background:
Objectives:
Methods:
Considering a rejection rate of 5%, the final required sample size is calculated to be 144 cases/group, totaling 288 cases.
Preoperative Preparation:
Fasting: 12 hours before ESWL. Water restriction: 4 hours before surgery.
Medication:
Oral pinaverium bromide tablets (100mg tid) administered:
One day before surgery On the day of surgery One day post-surgery
Postoperative Monitoring:
Maintain fasting for 24 hours post-surgery.
Blood tests at 6h and 24h to assess:
Amylase, lipase, CBC, PCT, CRP Document abdominal pain scores. If abdominal pain worsens or recurs, perform imaging (e.g., abdominal CT). Control Group Protocol
Preoperative Preparation:
Identical to the experimental group (fasting 12h, water restriction 4h before ESWL).
Placebo Administration:
Oral placebo (2 tablets tid) given:
One day before surgery On the day of surgery One day post-surgery
Postoperative Monitoring:
Identical to the experimental group (fasting, blood tests, pain scoring, and imaging if needed).
Endpoint evaluation:
Patients will be closely monitored during and after surgery, with a mandatory hospital stay of at least 48 hours. Endpoint events, including ESWL-related complications (acute pancreatitis, stone street, bleeding, infection, perforation, or others), will be recorded.
Outcomes: Pancreatitis incidence, pain scores, complications, lab markers (amylase, CRP), and imaging.
Statistical Methods Principle: All data were analyzed based on the intention-to-treat (ITT) principle.
Continuous variables were compared using Student's t-test or Mann-Whitney U test, as appropriate.
Categorical variables were analyzed using the chi-square test or Fisher's exact test, depending on data distribution.
A P-value \< 0.05 was considered statistically significant.
Inclusion:
Age 18-85, CP with ≥5mm pancreatic duct stones (head predominance).
Exclusion:
Termination Criteria:
Voluntary withdrawal from the study. 5. Study Arms
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preoperative, intraoperative, and postoperative oral administration of 100mg tid of povidone bromide in p-ESWL
Drug: Pinaverium bromide
Preoperative, intraoperative, and postoperative oral administration of 100mg tid of placebo in p-ESWL
Drug: Placebo for control group
Preoperative, intraoperative, and postoperative oral administration of 100mg povidonium bromide in P-ESWL
Preoperative, intraoperative, and postoperative oral placebo 100mg for P-ESWL
Incidence and grading of pancreatitis after P-ESWL (mild, moderate, and severe)
The definition of postoperative pancreatitis after P-ESWL is based on the 2012 Atlanta criteria. If at least two of the following three criteria are met, the diagnosis can be made: abdominal pain consistent with pancreatitis; Within 24 hours after surgery, amylase or lipase should be at least 3 times the normal upper limit; Imaging examination shows characteristic features of pancreatitis
Time frame: 24-48 hours after pancreatic ESWL procedure
Incidence of abdominal painful after P-ESWL
Using the Adult Abdominal Pain NRS Rating Scale (NRS) to record the post-ESWL painful.
Time frame: 24-48 hours after pancreatic ESWL procedure
Incidence of other adverse events of p-ESWL
Including bleeding, perforation, infection, steinstrasse. 1. Clinical evidence of bleeding Mild: hemoglobin drop \<3 g, no transfusion Moderate: Transfusion of ≤ 4 units, no angiographic intervention, or surgery Severe: Transfusion of≥ 5 units or intervention (angiographic or surgical) 2. Infection Mild: \> 38 °C for 24-48 hours Moderate:Requires \> 3 days of hospital treatment Severe: Abscess, septic shock, or intervention (percutaneous drainage or surgery) 3. Steinstrasse Mild: Severe abdominal pain without other post-ESWL complications Moderate: Combined with other complications, or requires \> 3 days of hospital treatment Severe: Combined with other complications; hospitalization for \> 10 days, or surgery 4. Perforation Mild: Possible, or very slight leak of fluid, treatable with fluids and suction for ≤3days Moderate: Any definite perforation treated medically for 4-10 days Severe: Medical treatment for \> 10 days or intervention (percutaneous or surgical)
Time frame: 24-48 hours after pancreatic ESWL procedure
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2027, 33 months after the start.
Of 46 non-industry interventional studies with no phase under Pancreatitis, Chronic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's planned 33 months is close to that.
Counting every sponsor, half of 49 studies reached it within 32 months; a quarter within 18 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Pinaverium
Yanqing Li