An observational study in Postoperative Pancreatic Fistula, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Peking Union Medical College Hospital · Observational
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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 one of 2 that started in 2024, is one of 5 observational ones, and was the 19th registered.
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
Browse Pancreatic Fistula studies →6 of the 20 studies in Pancreatic Fistula with a site in China are open now. Recruiting first, the newest first:
Second Affiliated Hospital, School of Medicine, Zhejiang University · Sites in China
Ages 18–75
Xijing Hospital of Digestive Diseases · Sites in China
Ages 18–75
Junjie Xiong · Sites in China
Ages 18–85
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18–75
Second Affiliated Hospital, School of Medicine, Zhejiang University · Sites in China
Ages 18–80
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 21 Pancreatic Fistula studies recruiting now, 13 (62%) set no upper age limit and 6 (29%) stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 600 is above the median of 120 across 44 observational studies indexed under Pancreatic Fistula.
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.
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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 |
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Among the 20 studies in Pancreatic Fistula with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions:
Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed.
CR-POPF is a multi-center observational prospective cohort study. The research team focuses on whether perioperative abnormal hyperglycemia can independently predict the occurrence of CR-POPF. It is proposed to realize the dynamic monitoring of perioperative blood glucose level by non-invasive continuous glucose monitoring (CGM), and perioperative continuous glucose monitoring can reflect the overall blood glucose trend and mode, which is helpful to further explore the correlation between perioperative abnormal blood glucose level and CR-POPF.
The investigators expect to enroll 600 patients. Based on our previous clinical experience, the incidence of postoperative pancreatic fistula is approximately 20%. We planned to enroll 600 patients during the 6-month enrollment period in three participating hospitals. The sample size would have a statistical power of 81.3% to detect an odds ratio (OR) greater than 1.34 or less than 0.75.
Measurement data consistent with normal distribution were expressed as mean ± standard deviation, and t-test was used for comparison between groups. When not consistent with normal distribution, the measurement data were expressed as quartiles, and the Wilcoxon-Mann-Whitney rank sum test was used for comparison between groups. Count data were expressed as frequency and percentage. Pearson chi-square test or Fisher's exact test was used for comparison between groups. The binary logistic regression method was used to screen the risk factors and stratify the risk levels, P \< 0.05 was considered statistically significant. A generalized estimation equation model was constructed to analyze the correlation between continuous blood glucose monitoring values and postoperative pancreatic fistula. The dependent variable in the model is whether there is pancreatic fistula after operation. The dependent variable in the model was the presence or absence of postoperative pancreatic fistula, and the main variable was the continuous glucose monitoring (CGM) value. The connection function uses the binomial distribution logit function. The multiple measurements of the same patient are set as the group-level variable, and the autocorrelation matrix is selected according to the Quasi-likelihood under Independence Model Criterion (QIC) value of the model. In addition to analysis using generalized estimating equations, continuous glucose monitoring data will be constructed, such as an analysis of the association between pancreatic fistula and the area under the curve for measurement and time beyond normal glucose values. The statistical software was STATA ( version 15.0; stata Corp., Texas, USA ) and R 3.6.1 software ( R Foundation for Statistical Computing, Vienna, Austria ), bilateral P \< 0.05 was considered statistically significant.
Adult patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy from March 2024 to October 2024.
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:
Clinically relevant postoperative pancreatic fistula
Clinically relevant postoperative pancreatic fistula is now redefined 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 surgery
Bile leakage
Bile leakage was defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis.
Time frame: 30 days after surgery
Chyle leak
Chyle leak was defined as output of milky-colored fluid from a drain, drain site, or wound on or after postoperative day 3, with a triglyceride content greater than or equal to 110 mg/dL (1.2 mmol/L).
Time frame: 30 days after surgery
Postpancreatectomy hemorrhage
Postpancreatectomy hemorrhage is defined by 3 parameters: onset, location, and severity. The onset is either early (24 hours after the end of the index operation) or late (24 hours). The location is either intraluminal or extraluminal. The severity of bleeding may be either mild or severe.
Time frame: 30 days after surgery
Abdominal infection
Abdominal infection was defined as a patient with symptoms such as shivering, high fever, abdominal distension, intestinal paralysis and other symptoms 3 or more days after surgery lasting for more than 24 hours.Laboratory examination results showed significant increases in white blood cell count, procalcitonin, and hypersensitive C-reactive protein, and imaging examination showed accumulation of fluid in the abdominal cavity. The diagnosis can be confirmed by the detection of bacteria or fungi in abdominal drainage or paracentesis fluid.
Time frame: 30 days after surgery
Delayed gastric emptying
Delayed gastric emptying was defined as indwelling gastric tube for more than 3 days after surgery, or re-indwelling gastric tube after 3 days due to vomiting or abdominal distension, or still unable to tolerate solid food 7 days after surgery under the premise of unobstructed gastrointestinal or duodenojejunal anastomosis and no obstruction of the small intestine.
Time frame: 30 days after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2025, 12 months after the start.
Of 22 observational studies under Pancreatic Fistula, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 53. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
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