Postoperative Pancreatic Fistula Clinical Trial
— CR-POPFOfficial title:
A Multicenter Prospective Cohort Study on the Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries
This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions: 1. What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries? 2. What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries? 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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | October 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients scheduled for elective pancreaticoduodenectomy - Patients scheduled for distal pancreatectomy - Patients scheduled for duodenum-preserving resection of pancreatic head. Exclusion Criteria: - Patients with functional pancreatic neuroendocrine tumors. - Patients with previous pancreatic surgery. - Patients with severe pancreatitis. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 30 days after surgery | |
Secondary | 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. | 30 days after surgery | |
Secondary | 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). | 30 days after surgery | |
Secondary | 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. | 30 days after surgery | |
Secondary | 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. | 30 days after surgery | |
Secondary | 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. | 30 days after surgery |
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