LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer

NCT05939063 | Recruiting DMC

• 1 other identifier: CSPAC-6
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter randomized controlled clinical trial proposed the criteria for selecting patients with early-stage left-sided pancreatic cancer and aimed to compare the perioperative and oncological outcomes of patients within the criteria who underwent laparoscopic radical antegrade modular pancreatosplenectomy versus laparoscopic distal pancreatosplenectomy.

Conditions

Left-sided Pancreatic Cancer

Keywords

Left-sided pancreatic cancer; Early-stage tumor; Laparoscopic radical antegrade modular pancreatosplenectomy; Laparoscopic distal pancreatosplecnectomy; Surgical complication; Oncologic prognosis

Outcome Measures

Primary Outcomes (3)

• R0 retroperitoneal margin rate

  R0 retroperitoneal margin rate diagnosed by postoperative pathological examination.

  From the date of surgery to 1 month after surgery.

• R0 transection margin rate

  R0 transection margin rate diagnosed by postoperative pathological examination.

  From the date of surgery to 1 month after surgery.

• Lymph node positive rate

  Lymph node positive rate diagnosed by postoperative pathological examination.

  From the date of surgery to 1 month after surgery.

Secondary Outcomes (4)

• Perioperative complication rate

  Within 90 days after surgery.

• Life quality satisfaction evaluated according to EORTC C30 scale

  Through study completion, an average of 3 year.

• Recurrence-free survival (RFS)

  Through study completion, an average of 3 year.

• Overall survival (OS)

  Through study completion, an average of 3 year.

Study Arms (2)

LRAMPS group

ACTIVE COMPARATOR

Patients who meet the inclusion and exclusion criteria will undergo laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) surgery.

Procedure: LRAMPS

LDP group

EXPERIMENTAL

Patients who meet the inclusion and exclusion criteria will undergo laparoscopic distal pancreatosplecnectomy (LDP) surgery.

Procedure: LDP

Interventions

LRAMPS PROCEDURE

For LRAMPS procedure, Gerota's fascia and perirenal fat capsule are removed, and the procedure is divided into anterior LRAMPS and posterior LRAMPS depending on whether the left adrenal gland is resected. The N1 station lymph nodes (i.e., groups 10, 11, and 18) in the body and tail of the pancreas are removed. If the tumor is located near the pancreatic body, the No. 9 lymph node group is additionally removed.

LRAMPS group

LDP PROCEDURE

For LDP procedure, the dissection plane is located behind the fusion fascia. The N1 station lymph nodes (i.e., groups 10, 11, and 18) in the body and tail of the pancreas are removed. If the tumor is located near the pancreatic body, the No. 9 lymph node group is additionally removed.

LDP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed as resectable left-sided pancreatic cancer before surgery.
• Imaging tumor diameter ≤ 4 cm.
• Located ≥ 1cm from the celiac trunk.
• Tumor didn't invade the fascial layer behind the pancreas.
• Be able to comply with research protocol.
• Voluntary participation and signed informed consent.

You may not qualify if:

• Received neoadjuvant therapy.
• Presence of liver or other distant metastasis.
• Multifocal or recurrent disease.
• History of other malignancies.
• Simultaneously participating in other clinical trials.

Sponsors & Collaborators

• Fudan University: lead
• The Third Affiliated Hospital of Soochow University: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (14)

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  PMID: 30080726 BACKGROUND

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• van Hilst J, de Rooij T, Klompmaker S, Rawashdeh M, Aleotti F, Al-Sarireh B, Alseidi A, Ateeb Z, Balzano G, Berrevoet F, Bjornsson B, Boggi U, Busch OR, Butturini G, Casadei R, Del Chiaro M, Chikhladze S, Cipriani F, van Dam R, Damoli I, van Dieren S, Dokmak S, Edwin B, van Eijck C, Fabre JM, Falconi M, Farges O, Fernandez-Cruz L, Forgione A, Frigerio I, Fuks D, Gavazzi F, Gayet B, Giardino A, Groot Koerkamp B, Hackert T, Hassenpflug M, Kabir I, Keck T, Khatkov I, Kusar M, Lombardo C, Marchegiani G, Marshall R, Menon KV, Montorsi M, Orville M, de Pastena M, Pietrabissa A, Poves I, Primrose J, Pugliese R, Ricci C, Roberts K, Rosok B, Sahakyan MA, Sanchez-Cabus S, Sandstrom P, Scovel L, Solaini L, Soonawalla Z, Souche FR, Sutcliffe RP, Tiberio GA, Tomazic A, Troisi R, Wellner U, White S, Wittel UA, Zerbi A, Bassi C, Besselink MG, Abu Hilal M; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Minimally Invasive versus Open Distal Pancreatectomy for Ductal Adenocarcinoma (DIPLOMA): A Pan-European Propensity Score Matched Study. Ann Surg. 2019 Jan;269(1):10-17. doi: 10.1097/SLA.0000000000002561.

  PMID: 29099399 BACKGROUND

• Strasberg SM, Drebin JA, Linehan D. Radical antegrade modular pancreatosplenectomy. Surgery. 2003 May;133(5):521-7. doi: 10.1067/msy.2003.146.

  PMID: 12773980 BACKGROUND

• Strasberg SM, Linehan DC, Hawkins WG. Radical antegrade modular pancreatosplenectomy procedure for adenocarcinoma of the body and tail of the pancreas: ability to obtain negative tangential margins. J Am Coll Surg. 2007 Feb;204(2):244-9. doi: 10.1016/j.jamcollsurg.2006.11.002. Epub 2007 Jan 4.

  PMID: 17254928 BACKGROUND

• Mitchem JB, Hamilton N, Gao F, Hawkins WG, Linehan DC, Strasberg SM. Long-term results of resection of adenocarcinoma of the body and tail of the pancreas using radical antegrade modular pancreatosplenectomy procedure. J Am Coll Surg. 2012 Jan;214(1):46-52. doi: 10.1016/j.jamcollsurg.2011.10.008.

  PMID: 22192922 BACKGROUND

• Takahashi A, Mise Y, Watanabe G, Yoshioka R, Ono Y, Inoue Y, Ito H, Takahashi Y, Kawasaki S, Saiura A. Radical antegrade modular pancreatosplenectomy enhances local control of the disease in patients with left-sided pancreatic cancer. HPB (Oxford). 2023 Jan;25(1):37-44. doi: 10.1016/j.hpb.2022.08.004. Epub 2022 Aug 20.

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• Tang W, Zhang YF, Zhao YF, Wei XF, Xiao H, Wu Q, Du CY, Qiu JG. Comparison of laparoscopic versus open radical antegrade modular pancreatosplenectomy for pancreatic cancer: A systematic review and meta-analysis. Int J Surg. 2022 Jul;103:106676. doi: 10.1016/j.ijsu.2022.106676. Epub 2022 May 13.

  PMID: 35577311 BACKGROUND

• Zhang H, Li Y, Liao Q, Xing C, Ding C, Zhang T, Guo J, Han X, Xu Q, Wu W, Zhao Y, Dai M. Comparison of minimal invasive versus open radical antegrade modular pancreatosplenectomy (RAMPS) for pancreatic ductal adenocarcinoma: a single center retrospective study. Surg Endosc. 2021 Jul;35(7):3763-3773. doi: 10.1007/s00464-020-07938-1. Epub 2020 Oct 8.

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• Wu EJ, Kabir T, Zhao JJ, Goh BKP. Minimally Invasive Versus Open Radical Antegrade Modular Pancreatosplenectomy: A Meta-Analysis. World J Surg. 2022 Jan;46(1):235-245. doi: 10.1007/s00268-021-06328-5. Epub 2021 Oct 5.

  PMID: 34609574 BACKGROUND

• Lee SH, Kang CM, Hwang HK, Choi SH, Lee WJ, Chi HS. Minimally invasive RAMPS in well-selected left-sided pancreatic cancer within Yonsei criteria: long-term (>median 3 years) oncologic outcomes. Surg Endosc. 2014 Oct;28(10):2848-55. doi: 10.1007/s00464-014-3537-3. Epub 2014 May 23.

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• Sato S, Oba A, Kato T, Kobayashi K, Wu YHA, Ono Y, Sato T, Ito H, Inoue Y, Takahashi Y. Feasibility of laparoscopic radical antegrade modular pancreatosplenectomy (RAMPS) as a standard treatment for distal resectable pancreatic cancer. Langenbecks Arch Surg. 2023 May 30;408(1):217. doi: 10.1007/s00423-023-02942-0.

  PMID: 37249638 BACKGROUND

• Sutton TL, Potter KC, Mayo SC, Pommier R, Gilbert EW, Sheppard BC. Complications in Distal Pancreatectomy versus Radical Antegrade Modular Pancreatosplenectomy: A Disease Risk Score Analysis Utilizing National Surgical Quality Improvement Project Data. World J Surg. 2022 Jul;46(7):1768-1775. doi: 10.1007/s00268-022-06545-6. Epub 2022 Apr 11.

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MeSH Terms

Conditions

Neoplasms

Study Officials

• Xianjun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaowu Xu, MD

  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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 11, 2023
• Study Start: October 1, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2028
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)