Pancreatic Fistula After Minimally Invasive Enucleation
NCT ID: NCT06557408
Last Updated: 2024-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
173 participants
OBSERVATIONAL
2019-07-01
2024-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Benign or low-grade malignant tumor of the pancreas.
3. Patients evaluated according to guidelines that indicate a need for surgery or a strong request for surgery.
4. Feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation.
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Willingness to comply with the follow-up programme of the study and other protocol requirements.
7. Voluntary participation and signed informed consent.
Exclusion Criteria
2. Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead.
3. 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).
4. Missing data due to patient loss of followup, etc.
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xian-Jun Yu
President of Fudan University Shanghai Cancer Center
Principal Investigators
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Xianjun Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Xiaowu Xu, MD
Role: STUDY_DIRECTOR
Fudan University
Locations
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Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Zhou 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.
Cauley 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.
Giuliani 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.
Duconseil 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.
Huttner 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.
Li 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.
Liu 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.
Papachristou 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.
Other Identifiers
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CSPAC-MIEN-2
Identifier Type: -
Identifier Source: org_study_id
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