LRAMPS Versus LDP in Early-stage Left-sided Pancreatic Cancer Within Fudan Criteria
Study Details
Study Description
Brief Summary
This multicenter open-label randomized controlled clinical trial proposed the Fudan 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Although prospective comparative studies are lacking, laparoscopic distal pancreatosplenectomy (LDP) was considered to be feasible, safe, and oncologically equivalent for treating pancreatic ductal adenocarcinoma (PDAC). However, the extent of posterior resection and the oncological safety of achieving complete N1 lymph node resection in LDP remain uncertain. Strasberg proposed radical antegrade modular pancreatosplenectomy (RAMPS) for the treatment of resectable left-sided PDAC and confirmed that this technique can achieve negative margins and satisfactory survival. Given the oncological equivalence of laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) and its advantages in short-term outcomes, several studies have assessed the feasibility of LRAMPS as the standard treatment for resectable left-sided PDAC. However, previous studies on LRAMPS have mostly included tumors staged T2 and above, and there is currently no research on the routine use of LRAMPS for early-stage tumors. We proposed the Fudan criteria for selecting patients with early-stage left-sided PDAC: (1) diameter ≤ 4 cm; (2) located ≥ 1 cm from the celiac trunk; (3) didn't invade the fascial layer behind the pancreas. This multicenter open-label randomized controlled clinical trial aims to compare the perioperative and oncological outcomes of patients within the criteria who underwent LRAMPS versus LDP.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: LRAMPS group Patients who meet the inclusion and exclusion criteria will undergo laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) surgery. |
Procedure: LRAMPS
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.
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| Experimental: LDP group Patients who meet the inclusion and exclusion criteria will undergo laparoscopic distal pancreatosplecnectomy (LDP) surgery. |
Procedure: LDP
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.
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Outcome Measures
Primary Outcome Measures
- R0 retroperitoneal margin rate [From the date of surgery to 1 month after surgery.]
R0 retroperitoneal margin rate diagnosed by postoperative pathological examination.
- R0 transection margin rate [From the date of surgery to 1 month after surgery.]
R0 transection margin rate diagnosed by postoperative pathological examination.
- Lymph node positive rate [From the date of surgery to 1 month after surgery.]
Lymph node positive rate diagnosed by postoperative pathological examination.
Secondary Outcome Measures
- Perioperative complication rate [Within 90 days after surgery.]
Adverse events that occur during or after the surgery, including the incidence of postoperative complications reported according to the Clavien-Dindo classification, clinical relevant postoperative pancreatic fistula (POPF), postoperative pancreatic hemorrhage (PPH), delayed gastric emptying (DGE), reoperation rate and mortality rate within 90 days after surgery.
- Recurrence-free survival (RFS) [Through study completion, an average of 3 year.]
The time of surgery to the time of tumor recurrence or death.
- Overall survival (OS) [Through study completion, an average of 3 year.]
The time from the surgery to death from any cause.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinically diagnosed as resectable left-sided pancreatic cancer before surgery.
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Imaging tumor diameter ≤ 4 cm.
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Located ≥ 1cm from the celiac trunk.
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Tumor didn't invade the fascial layer behind the pancreas.
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Be able to comply with research protocol.
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Voluntary participation and signed informed consent.
Exclusion Criteria:
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Received neoadjuvant therapy.
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Presence of liver or other distant metastasis.
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Multifocal or recurrent disease.
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History of other malignancies.
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Simultaneously participating in other clinical trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
- The Third Affiliated Hospital of Soochow University
- Qilu Hospital of Shandong University
Investigators
- Principal Investigator: Xianjun Yu, MD, PhD, Fudan University
- Study Director: Xiaowu Xu, MD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- CSPAC-6