Pancreatic Tumor, BenignNCT06557408
Pancreatic Fistula After Minimally Invasive Enucleation
An observational study of Pancreatic Tumor, Benign and Pancreatic Neuroendocrine Tumor, run by Fudan University at 1 site in China.
Trial summary
Patients suffering from postoperative pancreatic fistula (POPF) after minimally invasive enucleation (MIEN) show a characteristic pattern of longer duration and milder symptoms, which is different from pancreatic fistula after standard pancreatectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas
- How many people
- 173 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Jul 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of 182 consecutive patients who underwent MIEN at Fudan University Shanghai Cancer Center from July 2019 to November 2022. Nine patients with incomplete clinical data were excluded.
Who may be able to join
- Age between 18 and 70 years, regardless of gender.
- Benign or low-grade malignant tumor of the pancreas.
- Patients evaluated according to guidelines that indicate a need for surgery or a strong request for surgery.
- Feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Willingness to comply with the follow-up programme of the study and other protocol requirements.
- Voluntary participation and signed informed consent.
Who cannot join
- Concurrent presence of other malignant tumors.
- Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead.
- Severe impairment of cardiac, hepatic, or renal function (e.g., NYHA class 3-4 heart failure, ALT and/or AST levels exceeding three times the upper limit of normal, creatinine levels exceeding the upper limit of normal).
- Missing data due to patient loss of followup, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
Shanghai, Shanghai Municipality
About this study
Official title: Factors Influencing the Occurrence of Pancreatic Fistula After Minimally Invasive Pancreatic Enucleation and Predictive Models: a Prospective Cohort Study
Patients suffering from postoperative pancreatic fistula (POPF) after minimally invasive enucleation (MIEN) show a characteristic pattern of longer duration and milder symptoms, which is different from pancreatic fistula after standard pancreatectomy. This study aimed to analyze the factors influencing clinically-relevant POPF (CR-POPF) after MIEN, investigate and develop a personalized predictive model for accurate prediction of CR-POPF.
Read the detailed description
Minimally invasive enucleation (MIEN) has been widely used in managing benign and low-grade malignant pancreatic tumors, showing better protection of pancreatic function and better long-term outcomes compared to standard pancreatectomy.
However, the incidence of postoperative pancreatic fistula (POPF) after MIEN is higher compared to standard resection, mainly since a large part of the pancreatic wound is exposed, and the main pancreatic duct may be exposed or injured, etc. POPF is the most important postoperative complication, and it has become a major constraint to the conduct of pancreatic MIEN.
Although risk factors and predictive models for POPF in standard pancreatic surgery have been reported in the past, no predictive models have been reported specifically for MEN. With the increasing adoption of MIEN, there is an urgent need for a predictive model to guide the treatment and prognosis of POPF. Therefore, this study aims to conduct a cohort study, with data prospectively collected and retrospectively analyzed. The result of this study will provide a valuable reference for the development and application of MIEN.
- Conditions
- Pancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas
- Keywords
- Pancreatic benign or low-grade malignant tumors, Minimally invasive enucleation, Postoperative pancreatic fistula, Prediction model
- Medical subject headings
- Pancreatic Neoplasms, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive enucleation cohort | Surgical approaches to minimally invasive enucleation include laparoscopic or robotic-assisted procedures. During surgery, intraoperative ultrasonography is used to verify the position of the tumour in relation to the main pancreatic duct to ensure that injury to the main pancreatic duct is avoided and to help identify tumours within the pancreatic parenchyma. If injury to the main pancreatic duct is unavoidable, suture repair or bridging reconstruction techniques are used. If intraoperative freezing reveals the presence of high-grade dysplasia or invasive cancer, the procedure is converted to an oncological resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.
Measured: Within 90 days after surgery.
Secondary outcomes (1)
Perioperative complication rate according to the Clavien-Dindo classification
Adverse events occurring during or after surgery reported according to the Clavien-Dindo classification.
Measured: Within 90 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 posted16 Aug 2024
- Study start1 Jul 2019
- Primary completion30 Nov 2022
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Tumor, BenignStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xianjun Yu, MD, PhD, Principal investigator, Fudan UniversityXiaowu Xu, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557408
- Sponsor's protocol ID
- CSPAC-MIEN-2
- Status last verified
- Nov 2024
- First submitted
- 14 Aug 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crippa S, Bassi C, Salvia R, Falconi M, Butturini G, Pederzoli P. Enucleation of pancreatic neoplasms. Br J Surg. 2007 Oct;94(10):1254-9. doi: 10.1002/bjs.5833.
PubMed 17583892Zhou Y, Zhao M, Wu L, Ye F, Si X. Short- and long-term outcomes after enucleation of pancreatic tumors: An evidence-based assessment. Pancreatology. 2016 Nov-Dec;16(6):1092-1098. doi: 10.1016/j.pan.2016.07.006. Epub 2016 Jul 9.
PubMed 27423534Cauley CE, Pitt HA, Ziegler KM, Nakeeb A, Schmidt CM, Zyromski NJ, House MG, Lillemoe KD. Pancreatic enucleation: improved outcomes compared to resection. J Gastrointest Surg. 2012 Jul;16(7):1347-53. doi: 10.1007/s11605-012-1893-7. Epub 2012 Apr 24.
PubMed 22528577Giuliani T, De Pastena M, Paiella S, Marchegiani G, Landoni L, Festini M, Ramera M, Marinelli V, Casetti L, Esposito A, Bassi C, Salvia R. Pancreatic Enucleation Patients Share the Same Quality of Life as the General Population at Long-Term Follow-Up: A Propensity Score-Matched Analysis. Ann Surg. 2023 Mar 1;277(3):e609-e616. doi: 10.1097/SLA.0000000000004911. Epub 2021 Apr 14.
PubMed 33856383Duconseil P, Marchese U, Ewald J, Giovannini M, Mokart D, Delpero JR, Turrini O. A pancreatic zone at higher risk of fistula after enucleation. World J Surg Oncol. 2018 Aug 29;16(1):177. doi: 10.1186/s12957-018-1476-5.
PubMed 30157952Huttner FJ, Koessler-Ebs J, Hackert T, Ulrich A, Buchler MW, Diener MK. Meta-analysis of surgical outcome after enucleation versus standard resection for pancreatic neoplasms. Br J Surg. 2015 Aug;102(9):1026-36. doi: 10.1002/bjs.9819. Epub 2015 Jun 4.
PubMed 26041666Li Z, Zhuo Q, Shi Y, Chen H, Liu M, Liu W, Xu W, Chen C, Ji S, Yu X, Xu X. Minimally invasive enucleation of pancreatic tumors: The main pancreatic duct is no longer a restricted area. Heliyon. 2023 Nov 7;9(11):e21917. doi: 10.1016/j.heliyon.2023.e21917. eCollection 2023 Nov.
PubMed 38027678Liu R, Wakabayashi G, Palanivelu C, Tsung A, Yang K, Goh BKP, Chong CC, Kang CM, Peng C, Kakiashvili E, Han HS, Kim HJ, He J, Lee JH, Takaori K, Marino MV, Wang SN, Guo T, Hackert T, Huang TS, Anusak Y, Fong Y, Nagakawa Y, Shyr YM, Wu YM, Zhao Y. International consensus statement on robotic pancreatic surgery. Hepatobiliary Surg Nutr. 2019 Aug;8(4):345-360. doi: 10.21037/hbsn.2019.07.08.
PubMed 31489304Papachristou GI, Takahashi N, Chahal P, Sarr MG, Baron TH. Peroral endoscopic drainage/debridement of walled-off pancreatic necrosis. Ann Surg. 2007 Jun;245(6):943-51. doi: 10.1097/01.sla.0000254366.19366.69.
PubMed 17522520
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Occurrence of Pancreatic Fistula After Minimally Invasive Pancreatic Enucleation and Predictive Models: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06557408
- Acronym / sponsor ID
- CSPAC-MIEN-2
- Conditions
- Pancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas
- Keywords
- Pancreatic benign or low-grade malignant tumors, Minimally invasive enucleation, Postoperative pancreatic fistula, Prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 16 Aug 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.
Patients suffering from postoperative pancreatic fistula (POPF) after minimally invasive enucleation (MIEN) show a characteristic pattern of longer duration and milder symptoms, which is different from pancreatic fistula after standard pancreatectomy. This study aimed to analyze the factors influencing clinically-relevant POPF (CR-POPF) after MIEN, investigate and develop a personalized predictive model for accurate prediction of CR-POPF.
Detailed description
Minimally invasive enucleation (MIEN) has been widely used in managing benign and low-grade malignant pancreatic tumors, showing better protection of pancreatic function and better long-term outcomes compared to standard pancreatectomy.
However, the incidence of postoperative pancreatic fistula (POPF) after MIEN is higher compared to standard resection, mainly since a large part of the pancreatic wound is exposed, and the main pancreatic duct may be exposed or injured, etc. POPF is the most important postoperative complication, and it has become a major constraint to the conduct of pancreatic MIEN.
Although risk factors and predictive models for POPF in standard pancreatic surgery have been reported in the past, no predictive models have been reported specifically for MEN. With the increasing adoption of MIEN, there is an urgent need for a predictive model to guide the treatment and prognosis of POPF. Therefore, this study aims to conduct a cohort study, with data prospectively collected and retrospectively analyzed. The result of this study will provide a valuable reference for the development and application of MIEN.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive enucleation cohort | – | –Surgical approaches to minimally invasive enucleation include laparoscopic or robotic-assisted procedures. During surgery, intraoperative ultrasonography is used to verify the position of the tumour in relation to the main pancreatic duct to ensure that injury to the main pancreatic duct is avoided and to help identify tumours within the pancreatic parenchyma. If injury to the main pancreatic duct is unavoidable, suture repair or bridging reconstruction techniques are used. If intraoperative freezing reveals the presence of high-grade dysplasia or invasive cancer, the procedure is converted to an oncological resection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of 182 consecutive patients who underwent MIEN at Fudan University Shanghai Cancer Center from July 2019 to November 2022. Nine patients with incomplete clinical data were excluded.
Key inclusion criteria (7 listed)
- Age between 18 and 70 years, regardless of gender.
- Benign or low-grade malignant tumor of the pancreas.
- Patients evaluated according to guidelines that indicate a need for surgery or a strong request for surgery.
- Feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (4 listed)
- Concurrent presence of other malignant tumors.
- Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead.
- Severe impairment of cardiac, hepatic, or renal function (e.g., NYHA class 3-4 heart failure, ALT and/or AST levels exceeding three times the upper limit of normal, creatinine levels exceeding the upper limit of normal).
- Missing data due to patient loss of followup, etc.
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
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
Time frame: Within 90 days after surgery.
Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.
1 secondary outcome
Perioperative complication rate according to the Clavien-Dindo classification
Time frame: Within 90 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 17583892Crippa S, Bassi C, Salvia R, Falconi M, Butturini G, Pederzoli P. Enucleation of pancreatic neoplasms. Br J Surg. 2007 Oct;94(10):1254-9. doi: 10.1002/bjs.5833.
- Background: PubMed 27423534Zhou Y, Zhao M, Wu L, Ye F, Si X. Short- and long-term outcomes after enucleation of pancreatic tumors: An evidence-based assessment. Pancreatology. 2016 Nov-Dec;16(6):1092-1098. doi: 10.1016/j.pan.2016.07.006. Epub 2016 Jul 9.
- Background: PubMed 22528577Cauley CE, Pitt HA, Ziegler KM, Nakeeb A, Schmidt CM, Zyromski NJ, House MG, Lillemoe KD. Pancreatic enucleation: improved outcomes compared to resection. J Gastrointest Surg. 2012 Jul;16(7):1347-53. doi: 10.1007/s11605-012-1893-7. Epub 2012 Apr 24.
- Background: PubMed 33856383Giuliani T, De Pastena M, Paiella S, Marchegiani G, Landoni L, Festini M, Ramera M, Marinelli V, Casetti L, Esposito A, Bassi C, Salvia R. Pancreatic Enucleation Patients Share the Same Quality of Life as the General Population at Long-Term Follow-Up: A Propensity Score-Matched Analysis. Ann Surg. 2023 Mar 1;277(3):e609-e616. doi: 10.1097/SLA.0000000000004911. Epub 2021 Apr 14.
- Background: PubMed 30157952Duconseil P, Marchese U, Ewald J, Giovannini M, Mokart D, Delpero JR, Turrini O. A pancreatic zone at higher risk of fistula after enucleation. World J Surg Oncol. 2018 Aug 29;16(1):177. doi: 10.1186/s12957-018-1476-5.
- Background: PubMed 26041666Huttner FJ, Koessler-Ebs J, Hackert T, Ulrich A, Buchler MW, Diener MK. Meta-analysis of surgical outcome after enucleation versus standard resection for pancreatic neoplasms. Br J Surg. 2015 Aug;102(9):1026-36. doi: 10.1002/bjs.9819. Epub 2015 Jun 4.
- Background: PubMed 38027678Li Z, Zhuo Q, Shi Y, Chen H, Liu M, Liu W, Xu W, Chen C, Ji S, Yu X, Xu X. Minimally invasive enucleation of pancreatic tumors: The main pancreatic duct is no longer a restricted area. Heliyon. 2023 Nov 7;9(11):e21917. doi: 10.1016/j.heliyon.2023.e21917. eCollection 2023 Nov.
- Background: PubMed 31489304Liu R, Wakabayashi G, Palanivelu C, Tsung A, Yang K, Goh BKP, Chong CC, Kang CM, Peng C, Kakiashvili E, Han HS, Kim HJ, He J, Lee JH, Takaori K, Marino MV, Wang SN, Guo T, Hackert T, Huang TS, Anusak Y, Fong Y, Nagakawa Y, Shyr YM, Wu YM, Zhao Y. International consensus statement on robotic pancreatic surgery. Hepatobiliary Surg Nutr. 2019 Aug;8(4):345-360. doi: 10.21037/hbsn.2019.07.08.
- Background: PubMed 17522520Papachristou GI, Takahashi N, Chahal P, Sarr MG, Baron TH. Peroral endoscopic drainage/debridement of walled-off pancreatic necrosis. Ann Surg. 2007 Jun;245(6):943-51. doi: 10.1097/01.sla.0000254366.19366.69.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Tumor, Benign
Not yet recruiting
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
Fibroadenoma, Breast Fibroadenoma
RecruitingObservational study
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
Breast Cancer, Benign Breast Condition
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
RecruitingObservational study
Association Between Chronic Psychological Stress and Disease Course Outcomes in Pancreatic Cancer
Pancreatic Tumor, Benign, Pancreatic Cancer, Adult
Active, not recruitingObservational study
Johns Hopkins Breast Cancer Program Longitudinal Repository
Breast Cancer, Benign Breast Disease
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.
Xianjun Yu, MD, PhD principal investigator
Fudan University
Xiaowu Xu, MD study director
Fudan University
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 Pancreatic Tumor, Benign and Pancreatic Neuroendocrine Tumor, run by Fudan University 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 7 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Relevant Postoperative Pancreatic Fistula (time frame: Within 90 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 NCT06557408, which also lists 9 linked publications.
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 7 Nov 2024.