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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04855331
Other study ID # CSPAC-5
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2021
Est. completion date December 2025

Study information

Verified date May 2023
Source Fudan University
Contact Xianjun Yu, MD, PhD
Phone +86-13801669875
Email yuxianjun@fudanpci.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the safety and efficacy of laparoscopic versus open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer


Description:

Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive tumors with an increasing incidence and constitutes the fourth leading cause of cancer-related deaths. Radical resection remains the potential curative treatments for selected patients, and the Miami international evidence-based guidelines suggest that minimally invasive resection is feasible, safe, and oncologically equivalent for PDAC patients compared with open surgery. Furthermore, minimally invasive pancreatomy was associated with better overall and disease-free survival. However, only 15% to 20% PDAC patients are eligible for upfront surgery at the time of initial diagnosis. For borderline resectable PDAC, studies have confirmed that neoadjuvant therapy can provide more oncological benefits than upfront surgery, such as improved rates of margin-negative resection and decreased incidence of lymph node metastases. Additionally, short-term neoadjuvant therapy has been shown to improve postoperative survival. These findings support the use of short-term neoadjuvant therapy in borderline resectable PDACs, as recommended by the National Comprehensive Cancer Network guidelines. Neoadjuvant therapy can lead to severe fibrosis in the localized tumor tissue, which may hinder dissection and increase the risk of dangerous and bloody surgery. Furthermore, most anatomically borderline resectable PDACs have a large diameter and are in close proximity to major blood vessels, making the surgical procedure more complex and challenging. To date, there is insufficient evidence to determine the feasibility and safety of minimally invasive pancreatectomy compared to open surgery after neoadjuvant therapy. This study aims to evaluate the safety and efficacy of laparoscopic pancreatoduodenectomy (LPD) versus open pancreatoduodenectomy (OPD) for borderline resectable PDAC following neoadjuvant chemotherapy (NACT) through a multicenter randomized controlled clinical trial.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Before neoadjuvant chemotherapy, pancreatic ductal adenocarcinoma was confirmed by pathology; - According to the guidelines, neoadjuvant chemotherapy should be performed before surgery, including patients with resectable pancreatic cancer (RPC) with high risk factors (biologically borderline resectable), anatomically borderline resectable pancreatic cancer (BRPC) with good physical condition; - Receive at least 2 cycles of neoadjuvant chemotherapy before radical surgery; - After neoadjuvant chemotherapy, the patient can be further treated by laparoscopic or open surgery; - No obvious surgical contraindications, suitable for minimally invasive surgery; - ECOG score of preoperative physical condition was 0-1; - No history of preoperative pancreatitis; - Preoperative PET-CT or other imaging examination did not show distant metastasis; - The expected postoperative survival time was more than 3 months; - Be able to comply with research protocol, follow-up plan and other protocol requirements; - Voluntary participation and signed informed consent. Exclusion Criteria: - Neoadjuvant chemotherapy is not suitable before operation according to the guidelines; - Invasion of adjacent organs, abdominal cavity or distant metastasis was found by introperative exploration; - Patients requiring total pancreatectomy; - Severe impairment of heart, liver and kidney function; - Patients with other malignancies or hematological diseases; - The patient is pregnant, planning to be pregnant or lactating; - Before surgery, anti-cancer therapy except neoadjuvant chemotherapy were performed, including interventional chemoembolization, ablation, radiotherapy and molecular targeted therapy; - Participants in other clinical trials; - Tumor progression occurred during neoadjuvant chemotherapy. After neoadjuvant chemotherapy, patients failed reach the standard of laparoscopic surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic pancreatoduodenectomy
Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Open pancreatoduodenectomy
Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Locations

Country Name City State
China Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (7)

Lead Sponsor Collaborator
Fudan University Fujian Provincial Hospital, Qilu Hospital of Shandong University, The Third Affiliated Hospital of Soochow University, Tongji Hospital, West China Hospital, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

Asbun HJ, Moekotte AL, Vissers FL, Kunzler F, Cipriani F, Alseidi A, D'Angelica MI, Balduzzi A, Bassi C, Bjornsson B, Boggi U, Callery MP, Del Chiaro M, Coimbra FJ, Conrad C, Cook A, Coppola A, Dervenis C, Dokmak S, Edil BH, Edwin B, Giulianotti PC, Han HS, Hansen PD, van der Heijde N, van Hilst J, Hester CA, Hogg ME, Jarufe N, Jeyarajah DR, Keck T, Kim SC, Khatkov IE, Kokudo N, Kooby DA, Korrel M, de Leon FJ, Lluis N, Lof S, Machado MA, Demartines N, Martinie JB, Merchant NB, Molenaar IQ, Moravek C, Mou YP, Nakamura M, Nealon WH, Palanivelu C, Pessaux P, Pitt HA, Polanco PM, Primrose JN, Rawashdeh A, Sanford DE, Senthilnathan P, Shrikhande SV, Stauffer JA, Takaori K, Talamonti MS, Tang CN, Vollmer CM, Wakabayashi G, Walsh RM, Wang SE, Zinner MJ, Wolfgang CL, Zureikat AH, Zwart MJ, Conlon KC, Kendrick ML, Zeh HJ, Hilal MA, Besselink MG; International Study Group on Minimally Invasive Pancreas Surgery (I-MIPS). The Miami International Evidence-based Guidelines on Minimally Invasive Pancreas Resection. Ann Surg. 2020 Jan;271(1):1-14. doi: 10.1097/SLA.0000000000003590. — View Citation

Chawla A, Molina G, Pak LM, Rosenthal M, Mancias JD, Clancy TE, Wolpin BM, Wang J. Neoadjuvant Therapy is Associated with Improved Survival in Borderline-Resectable Pancreatic Cancer. Ann Surg Oncol. 2020 Apr;27(4):1191-1200. doi: 10.1245/s10434-019-08087-z. Epub 2019 Dec 4. — View Citation

Croome KP, Farnell MB, Que FG, Reid-Lombardo KM, Truty MJ, Nagorney DM, Kendrick ML. Total laparoscopic pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: oncologic advantages over open approaches? Ann Surg. 2014 Oct;260(4):633-8; discussion 638-40. doi: 10.1097/SLA.0000000000000937. — View Citation

de Rooij T, van Hilst J, van Santvoort H, Boerma D, van den Boezem P, Daams F, van Dam R, Dejong C, van Duyn E, Dijkgraaf M, van Eijck C, Festen S, Gerhards M, Groot Koerkamp B, de Hingh I, Kazemier G, Klaase J, de Kleine R, van Laarhoven C, Luyer M, Patijn G, Steenvoorde P, Suker M, Abu Hilal M, Busch O, Besselink M; Dutch Pancreatic Cancer Group. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD): A Multicenter Patient-blinded Randomized Controlled Trial. Ann Surg. 2019 Jan;269(1):2-9. doi: 10.1097/SLA.0000000000002979. — View Citation

Jang JY, Han Y, Lee H, Kim SW, Kwon W, Lee KH, Oh DY, Chie EK, Lee JM, Heo JS, Park JO, Lim DH, Kim SH, Park SJ, Lee WJ, Koh YH, Park JS, Yoon DS, Lee IJ, Choi SH. Oncological Benefits of Neoadjuvant Chemoradiation With Gemcitabine Versus Upfront Surgery in Patients With Borderline Resectable Pancreatic Cancer: A Prospective, Randomized, Open-label, Multicenter Phase 2/3 Trial. Ann Surg. 2018 Aug;268(2):215-222. doi: 10.1097/SLA.0000000000002705. — View Citation

Miyasaka Y, Ohtsuka T, Kimura R, Matsuda R, Mori Y, Nakata K, Kakihara D, Fujimori N, Ohno T, Oda Y, Nakamura M. Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel for Borderline Resectable Pancreatic Cancer Potentially Improves Survival and Facilitates Surgery. Ann Surg Oncol. 2019 May;26(5):1528-1534. doi: 10.1245/s10434-019-07309-8. Epub 2019 Mar 13. — View Citation

Mokdad AA, Minter RM, Zhu H, Augustine MM, Porembka MR, Wang SC, Yopp AC, Mansour JC, Choti MA, Polanco PM. Neoadjuvant Therapy Followed by Resection Versus Upfront Resection for Resectable Pancreatic Cancer: A Propensity Score Matched Analysis. J Clin Oncol. 2017 Feb 10;35(5):515-522. doi: 10.1200/JCO.2016.68.5081. Epub 2016 Sep 30. — View Citation

Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, Lopez-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14. — View Citation

Reni M, Balzano G, Zanon S, Zerbi A, Rimassa L, Castoldi R, Pinelli D, Mosconi S, Doglioni C, Chiaravalli M, Pircher C, Arcidiacono PG, Torri V, Maggiora P, Ceraulo D, Falconi M, Gianni L. Safety and efficacy of preoperative or postoperative chemotherapy for resectable pancreatic adenocarcinoma (PACT-15): a randomised, open-label, phase 2-3 trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):413-423. doi: 10.1016/S2468-1253(18)30081-5. Epub 2018 Apr 4. — View Citation

Roland CL, Yang AD, Katz MH, Chatterjee D, Wang H, Lin H, Vauthey JN, Pisters PW, Varadhachary GR, Wolff RA, Crane CH, Lee JE, Fleming JB. Neoadjuvant therapy is associated with a reduced lymph node ratio in patients with potentially resectable pancreatic cancer. Ann Surg Oncol. 2015 Apr;22(4):1168-75. doi: 10.1245/s10434-014-4192-6. Epub 2014 Oct 29. — View Citation

Sugimoto M, Takahashi N, Farnell MB, Smyrk TC, Truty MJ, Nagorney DM, Smoot RL, Chari ST, Carter RE, Kendrick ML. Survival benefit of neoadjuvant therapy in patients with non-metastatic pancreatic ductal adenocarcinoma: A propensity matching and intention-to-treat analysis. J Surg Oncol. 2019 Nov;120(6):976-984. doi: 10.1002/jso.25681. Epub 2019 Aug 26. — View Citation

Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. doi: 10.1200/JCO.19.02274. Epub 2020 Feb 27. — View Citation

Wang M, Li D, Chen R, Huang X, Li J, Liu Y, Liu J, Cheng W, Chen X, Zhao W, Li J, Tan Z, Huang H, Li D, Zhu F, Qin T, Ma J, Yu G, Zhou B, Zheng S, Tang Y, Han W, Meng L, Ke J, Feng F, Chen B, Yin X, Chen W, Ma H, Xu J, Liu Y, Lin R, Dong Y, Yu Y, Liu J, Zhang H, Qin R; Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Jun;6(6):438-447. doi: 10.1016/S2468-1253(21)00054-6. Epub 2021 Apr 27. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Recurrence free survival The time from surgery until tumor recurrence, death or the last follow-up time. up to 5 years after the surgery
Other Overall survival The time from surgery until death or the last follow-up time. up to 5 years after the surgery
Other Postoperative quality of life Postoperative quality of life was assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale QLQ-C30 and pancreatic cancer quality of life specific scale QLQ-PAN26. up to 5 years after the surgery
Primary Postoperative complications The specific postoperative complications of pancreatic surgery include postoperative pancreatic fistula, postoperative hemorrhage and gastroparesis. Other common postoperative complications include abdominal infection, incision nonunion and so on. The degree of complications was evaluated by Clavien-Dindo grading system. 90 days after the surgery
Secondary Length of stay The length of hospital stay from the end of surgery to discharge or death. The length of hospital stay for readmission after discharge is not included. 90 days after the surgery
Secondary Operation time The time from the beginning to the end of the surgery. 1 day
Secondary R0 resection rate Postoperative pathology confirmed that there were no tumor cells in the tissue within 1 mm from the surgical margin. 30 days after the surgery
Secondary The 90 days readmission rate The rate of rehospitalization within 90 days after surgery due to aggravation. 90 days after the surgery
Secondary The 90 days mortality rate after operation The mortality within 90 days after surgery. 90 days after the surgery
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