Pancreatic Fistula After Minimally Invasive Enucleation

NCT06557408 | Completed DMC

• 1 other identifier: CSPAC-MIEN-2
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 90 days after surgery.

Secondary Outcomes (1)

• Perioperative complication rate according to the Clavien-Dindo classification

  Within 90 days after surgery.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China

Shanghai, Shanghai Municipality, China

Location

Related Publications (9)

• 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.

  PMID: 17583892 BACKGROUND

• 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.

  PMID: 27423534 BACKGROUND

• 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.

  PMID: 22528577 BACKGROUND

• 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.

  PMID: 33856383 BACKGROUND

• 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.

  PMID: 30157952 BACKGROUND

• 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.

  PMID: 26041666 BACKGROUND

• 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.

  PMID: 38027678 BACKGROUND

• 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.

  PMID: 31489304 BACKGROUND

• 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.

  PMID: 17522520 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Xianjun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaowu Xu, MD

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: July 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: July 30, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)