Postoperative Pancreatic FistulaCR-POPFNCT06289530
Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries
An observational study of Postoperative Pancreatic Fistula, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pancreatic Fistula
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy from March 2024 to October 2024.
Who may be able to join
- Patients scheduled for elective pancreaticoduodenectomy
- Patients scheduled for distal pancreatectomy
- Patients scheduled for duodenum-preserving resection of pancreatic head.
Who cannot join
- Patients with functional pancreatic neuroendocrine tumors.
- Patients with previous pancreatic surgery.
- Patients with severe pancreatitis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100730
LING LAN, MD, lanling_1988@163.com
About this study
Official 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:
- What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries?
- 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.
Read the detailed description
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.
- Conditions
- Postoperative Pancreatic Fistula
- Keywords
- clinically relevant postoperative pancreatic fistula, pancreatic surgery, perioperative interstitial fluid glucose level
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after surgery
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Mar 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YuGuang Huang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289530
- Sponsor's protocol ID
- 2023XAGG0070-1
- Acronym
- CR-POPF
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lan L, Zhang Y, Zhang L, Zhang Y, Shen L, Huang Y. Association between perioperative continuous glucose monitoring and clinically relevant postoperative pancreatic fistula (CR-POPF) in pancreatic surgery: a protocol for a prospective cohort study. BMJ Open. 2025 Jun 17;15(6):e092046. doi: 10.1136/bmjopen-2024-092046.
PubMed 40527571
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06289530
- Acronym / sponsor ID
- CR-POPF / 2023XAGG0070-1
- Conditions
- Postoperative Pancreatic Fistula
- Keywords
- clinically relevant postoperative pancreatic fistula, pancreatic surgery, perioperative interstitial fluid glucose level
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions:
- What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries?
- 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy from March 2024 to October 2024.
Key inclusion criteria (3 listed)
- Patients scheduled for elective pancreaticoduodenectomy
- Patients scheduled for distal pancreatectomy
- Patients scheduled for duodenum-preserving resection of pancreatic head.
Key exclusion criteria (3 listed)
- Patients with functional pancreatic neuroendocrine tumors.
- Patients with previous pancreatic surgery.
- Patients with severe pancreatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically relevant postoperative pancreatic fistula
Time frame: 30 days after surgery
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.
5 secondary outcomes
Bile leakage
Time frame: 30 days after surgery
Chyle leak
Time frame: 30 days after surgery
Postpancreatectomy hemorrhage
Time frame: 30 days after surgery
Abdominal infection
Time frame: 30 days after surgery
Delayed gastric emptying
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 40527571Lan L, Zhang Y, Zhang L, Zhang Y, Shen L, Huang Y. Association between perioperative continuous glucose monitoring and clinically relevant postoperative pancreatic fistula (CR-POPF) in pancreatic surgery: a protocol for a prospective cohort study. BMJ Open. 2025 Jun 17;15(6):e092046. doi: 10.1136/bmjopen-2024-092046.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YuGuang Huang, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pancreatic Fistula, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LING LAN, MD (+86-18515311407, lanling_1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically relevant postoperative pancreatic fistula (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.