Long-term Prognosis for Non-functional Neuroendocrine Tumors of the Pancreatic Body and Tail ≤ 3cm

NCT05907824 | Unknown DMC

• 1 other identifier: CSPAC-NEN-5
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to quantify the malignant potential of non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm by collecting real-world data from large pancreatic centers across the country, and to evaluate the appropriateness of parenchyma-sparing resection and oncologic resection.

Conditions

Non Functioning Pancreatic Endocrine Tumor

Keywords

Non Functioning Pancreatic Endocrine Tumor; Body and Tail of the Pancreas; Parenchyma-sparing Resection; Oncologic Resection; Long-term Prognosis

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  The time from the surgery to death from any cause.

  Through study completion, an average of 1 year.

• Disease-free survival (DFS)

  The time of surgery to the time of tumor recurrence or death from any cause.

  Through study completion, an average of 1 year.

Secondary Outcomes (6)

• Perioperative complication rate

  Within 90 days after surgery.

• Postoperative pathological staging

  From the date of surgery to 1 month after surgery.

• G staging

  From the date of surgery to 1 month after surgery.

• R0 resection rate

  From the date of surgery to 1 month after surgery.

• Lymph node positivity rate

  From the date of surgery to 1 month after surgery.

Study Arms (2)

Parenchyma-sparing Resections

Parenchyma-sparing resections, including open, laparoscopic, or robotic pancreatic enucleation, duodenum-preserving pancreatic head resection, middle segment pancreatectomy, and spleen-preserving distal pancreatectomy, without standard lymph node dissection.

Other: Histopathological review, long-term prognosis and quality of life follow-up

Oncologic Resections

Oncologic resections, including open, laparoscopic, or robotic pancreaticoduodenectomy or distal pancreatectomy, with standard lymph node dissection.

Other: Histopathological review, long-term prognosis and quality of life follow-up

Interventions

Histopathological review, long-term prognosis and quality of life follow-up OTHER

Histopathological review, long-term prognosis and quality of life follow-up

Oncologic Resections; Parenchyma-sparing Resections

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm.

You may qualify if:

• Non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm.

You may not qualify if:

• Presence of liver or distant metastasis.
• Presence of concomitant malignancy.
• Multifocal or recurrent disease.
• Presence of hereditary syndrome (MEN1, VHL, NF).
• Presence of symptoms (specific symptoms of clinical syndromes suspected to be related to excessive secretion of bioactive compounds).
• History of preoperative antitumor therapy.
• Loss to follow-up.

Sponsors & Collaborators

• Fudan University: lead
• The Third Affiliated Hospital of Soochow University: collaborator
• Qilu Hospital of Shandong University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Southern Medical University, China: collaborator

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (13)

• Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.

  PMID: 28448665 BACKGROUND

• Falconi M, Eriksson B, Kaltsas G, Bartsch DK, Capdevila J, Caplin M, Kos-Kudla B, Kwekkeboom D, Rindi G, Kloppel G, Reed N, Kianmanesh R, Jensen RT; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for the Management of Patients with Functional Pancreatic Neuroendocrine Tumors and Non-Functional Pancreatic Neuroendocrine Tumors. Neuroendocrinology. 2016;103(2):153-71. doi: 10.1159/000443171. Epub 2016 Jan 5. No abstract available.

  PMID: 26742109 BACKGROUND

• Halfdanarson TR, Strosberg JR, Tang L, Bellizzi AM, Bergsland EK, O'Dorisio TM, Halperin DM, Fishbein L, Eads J, Hope TA, Singh S, Salem R, Metz DC, Naraev BG, Reidy-Lagunes DL, Howe JR, Pommier RF, Menda Y, Chan JA. The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Pancreatic Neuroendocrine Tumors. Pancreas. 2020 Aug;49(7):863-881. doi: 10.1097/MPA.0000000000001597.

  PMID: 32675783 BACKGROUND

• Gratian L, Pura J, Dinan M, Roman S, Reed S, Sosa JA. Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States. Ann Surg Oncol. 2014 Oct;21(11):3515-21. doi: 10.1245/s10434-014-3769-4. Epub 2014 May 20.

  PMID: 24841347 BACKGROUND

• Xu JZ, Wang WQ, Zhang SR, Xu HX, Wu CT, Qi ZH, Gao HL, Ni QX, Liu L, Yu XJ. Intrinsic Contact Between T and N Classifications in Resected Well-Moderately Differentiated Locoregional Pancreatic Neuroendocrine Neoplasms. Ann Surg Oncol. 2018 Mar;25(3):647-654. doi: 10.1245/s10434-017-6289-1. Epub 2017 Dec 12.

  PMID: 29235006 BACKGROUND

• Tanaka M, Heckler M, Mihaljevic AL, Probst P, Klaiber U, Heger U, Schimmack S, Buchler MW, Hackert T. Systematic Review and Metaanalysis of Lymph Node Metastases of Resected Pancreatic Neuroendocrine Tumors. Ann Surg Oncol. 2021 Mar;28(3):1614-1624. doi: 10.1245/s10434-020-08850-7. Epub 2020 Jul 27.

  PMID: 32720049 BACKGROUND

• Partelli S, Massironi S, Zerbi A, Niccoli P, Kwon W, Landoni L, Panzuto F, Tomazic A, Bongiovanni A, Kaltsas G, Sauvanet A, Bertani E, Mazzaferro V, Caplin M, Armstrong T, Weickert MO, Ramage J, Segelov E, Butturini G, Staettner S, Cives M, Frilling A, Moulton CA, He J, Boesch F, Selberheer A, Twito O, Castaldi A, De Angelis CG, Gaujoux S, Holzer K, Wilson CH, Almeamar H, Vigia E, Muffatti F, Luca M, Lania A, Ewald J, Kim H, Salvia R, Rinzivillo M, Smid A, Gardini A, Tsoli M, Hentic O, Colombo S, Citterio D, Toumpanakis C, Ramsey E, Randeva HS, Srirajaskanthan R, Croagh D, Regi P, Gasteiger S, Invernizzi P, Ridolfi C, Giovannini M, Jang JY, Bassi C, Falconi M. Management of asymptomatic sporadic non-functioning pancreatic neuroendocrine neoplasms no larger than 2 cm: interim analysis of prospective ASPEN trial. Br J Surg. 2022 Nov 22;109(12):1186-1190. doi: 10.1093/bjs/znac267. No abstract available.

  PMID: 35986682 BACKGROUND

• Partelli S, Mazza M, Andreasi V, Muffatti F, Crippa S, Tamburrino D, Falconi M. Management of small asymptomatic nonfunctioning pancreatic neuroendocrine tumors: Limitations to apply guidelines into real life. Surgery. 2019 Aug;166(2):157-163. doi: 10.1016/j.surg.2019.04.003. Epub 2019 May 17.

  PMID: 31109657 BACKGROUND

• Chivukula SV, Tierney JF, Hertl M, Poirier J, Keutgen XM. Operative resection in early stage pancreatic neuroendocrine tumors in the United States: Are we over- or undertreating patients? Surgery. 2020 Jan;167(1):180-186. doi: 10.1016/j.surg.2019.04.061. Epub 2019 Sep 16.

  PMID: 31537303 BACKGROUND

• Pea A, Tanno L, Nykanen T, Prasad P, Tuncer C, Robinson S, Marchegiani G. Comparison of Oncological and Surgical Outcomes Between Formal Pancreatic Resections and Parenchyma-Sparing Resections for Small PanNETs (<2 cm): Pancreas2000 Research and Educational Program (Course 9) Study Protocol. Front Med (Lausanne). 2020 Sep 10;7:559. doi: 10.3389/fmed.2020.00559. eCollection 2020.

  PMID: 33015105 BACKGROUND

• Nesti C, Brautigam K, Benavent M, Bernal L, Boharoon H, Botling J, Bouroumeau A, Brcic I, Brunner M, Cadiot G, Camara M, Christ E, Clerici T, Clift AK, Clouston H, Cobianchi L, Cwikla JB, Daskalakis K, Frilling A, Garcia-Carbonero R, Grozinsky-Glasberg S, Hernando J, Hervieu V, Hofland J, Holmager P, Inzani F, Jann H, Jimenez-Fonseca P, Kacmaz E, Kaemmerer D, Kaltsas G, Klimacek B, Knigge U, Kolasinska-Cwikla A, Kolb W, Kos-Kudla B, Kunze CA, Landolfi S, La Rosa S, Lopez CL, Lorenz K, Matter M, Mazal P, Mestre-Alagarda C, Del Burgo PM, van Dijkum EJMN, Oleinikov K, Orci LA, Panzuto F, Pavel M, Perrier M, Reims HM, Rindi G, Rinke A, Rinzivillo M, Sagaert X, Satiroglu I, Selberherr A, Siebenhuner AR, Tesselaar MET, Thalhammer MJ, Thiis-Evensen E, Toumpanakis C, Vandamme T, van den Berg JG, Vanoli A, van Velthuysen MF, Verslype C, Vorburger SA, Lugli A, Ramage J, Zwahlen M, Perren A, Kaderli RM. Hemicolectomy versus appendectomy for patients with appendiceal neuroendocrine tumours 1-2 cm in size: a retrospective, Europe-wide, pooled cohort study. Lancet Oncol. 2023 Feb;24(2):187-194. doi: 10.1016/S1470-2045(22)00750-1. Epub 2023 Jan 11.

  PMID: 36640790 BACKGROUND

• Bolm L, Nebbia M, Wei AC, Zureikat AH, Fernandez-Del Castillo C, Zheng J, Pulvirenti A, Javed AA, Sekigami Y, Petruch N, Qadan M, Lillemoe KD, He J, Ferrone CR; PAncreatic Neuroendocrine Disease Alliance (PANDA). Long-term Outcomes of Parenchyma-sparing and Oncologic Resections in Patients With Nonfunctional Pancreatic Neuroendocrine Tumors <3 cm in a Large Multicenter Cohort. Ann Surg. 2022 Sep 1;276(3):522-531. doi: 10.1097/SLA.0000000000005559. Epub 2022 Jun 27.

  PMID: 35758433 BACKGROUND

• Tsuchikawa T, Tanaka K, Nakanishi Y, Asano T, Noji T, Nakamura T, Okamura K, Shichinohe T, Hirano S. Clinical Impact of Organ-Preserving Surgery for Pancreatic Neuroendocrine Neoplasms: A Single-Center Experience. Pancreas. 2021 Feb 1;50(2):196-200. doi: 10.1097/MPA.0000000000001739.

  PMID: 33565795 BACKGROUND

MeSH Terms

Conditions

Non functioning pancreatic endocrine tumor

Study Officials

• Xianjun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Shunrong Ji, PhD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Xianjun Yu, MD, PhD

CONTACT

+86-13801669875; yuxianjun@fudanpci.org

Zheng Li, MD

CONTACT

+86-18521097686; lizheng@fudanpci.org

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: May 29, 2023
• First Posted: June 18, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)