A Phase 4 interventional study of Somatostatin in Pancreatic Fistula, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment
Among 20 studies in Pancreatic Fistula with a site in China — 6 open to participants now, 6 under way, none of them phase 3. Pancreatic Fistula · China.
Among the 20 studies in Pancreatic Fistula with a site in China, this one is the 6th largest by enrollment of the 15 interventional ones, is one of 4 that started in 2018, is the only one in phase 4, and was the 3rd registered.
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's enrollment of 205 is above the median of 110 across 77 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →6 of the 20 studies in Pancreatic Fistula with a site in China are open now, in 1 country. Each count lists the studies.
Of the 21 Pancreatic Fistula studies recruiting now, 13 (62%) set no upper age limit and 6 (29%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 4 started in 2018.
Median enrollment 162 across the 15 interventional studies, 384 across the 5 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
None of the 20 has an industry lead sponsor. The 10 most frequent:
Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Peking Union Medical College Hospital has 4 studies filed under Pancreatic Fistula — fewer than ten, so there is no comparison to draw.
1 of the studies in Pancreatic Fistula 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 |
|---|---|
| NCT05657366Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPeritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy | 2026-12-31 |
Among the 20 studies in Pancreatic Fistula with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study is designed to assess the preventive effects of somatostatin on post-operation pancreatic fistula in intermediate risk patients after pancreaticoduodenectomy. Patients assigned into the treatment group will be continuous intravenous infusion with the somatostatin (Stilamin®) in addition to conventional treatments (including infection prevention, nutrition support and acid suppression therapy, etc.).The pancreatic fistula incidence will be monitored within 30 days after operation.
This is a multi-center randomized, controlled clinical trial. A total of 200 patients are expected to be recruited. Each trial center recruits subjects based on the sequential principle and inspect the inclusion and exclusion criteria after PD and subjects meeting the standard are assigned randomly to the treatment group or control group. Apart from conventional treatments (including infection prevention, nutrition support and acid suppression therapy, etc.), the treatment group will be continuous intravenous infusion with the somatostatin (Stilamin®) of 250μg/h for 120h (total dose of 6mg/day x 5 days=30mg), beginning within 3 hours after the operation; the control group will accept conventional treatments other than the Stilamin.
The pancreatic fistula incidence, biochemical leak incidence, morbidity and number of other complications related to the pancreatectomy, length of stay in hospital, hospitalization cost, re-admission rate and re-operation rate will be monitored within 30 days after operation. Subjects will be visited for 5 times from the start to the end of the study.
Statistical Methods:Number of patients who had pancreatic fistula after surgery will be analyzed using Chi-square test.Secondary endpoints: Continuous variates will be described as mean± SD; attempted to be analyzed using analysis of variance. Categorical variates will be described as rate; attempted to be analyzed using Chi-square test.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin in addition to postoperative conventional treatment.
Drug: Somatostatin
Patients in the control group will receive the postoperative conventional treatment, without addition of any new medicines.
Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin (Stilamin®) of 250μg/h, beginning within 3 hours (Visit 1) after the operation and lasting for 120 hours (each subject will receive the Stilamin of 30mg in total), and other postoperative conventional treatment protocol remain unchanged.
Also known as: Stilamin
Incidence of post-operative pancreatic fistula
A clinically relevant postoperative pancreatic fistula is now defined as a drain output of any measurable volume of fluid with an amylase level \>3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.
Time frame: 30 days after operation
Plan to share: No
Ran from Jun 2018 to primary completion in May 2019, 11 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Somatostatin
Peking Union Medical College Hospital →