Left-sided Pancreatic CancerNCT05939063
LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer
A study testing LRAMPS and LDP in people with Left-sided Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left-sided Pancreatic Cancer
- What is being tested?
- LRAMPS and LDP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Received neoadjuvant therapy.
- Presence of liver or other distant metastasis.
- Multifocal or recurrent disease.
- History of other malignancies.
- Simultaneously participating in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, MD, PhD, +86-13801669875, yuxianjun@fudanpci.org
Xianjun Yu, MD, PhD
About this study
Official title: Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial
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.
Read the 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 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.
- Conditions
- Left-sided Pancreatic Cancer
- Being tested
- LRAMPS, LDP
- Keywords
- Left-sided pancreatic cancer, Early-stage tumor, Laparoscopic radical antegrade modular pancreatosplenectomy, Laparoscopic distal pancreatosplecnectomy, Surgical complication, Oncologic prognosis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LRAMPSProcedure or surgery
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.
LDPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LRAMPS group | Active comparator | Patients who meet the inclusion and exclusion criteria will undergo laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) surgery. Receives: Procedure: LRAMPS |
| LDP group | Experimental | Patients who meet the inclusion and exclusion criteria will undergo laparoscopic distal pancreatosplecnectomy (LDP) surgery. Receives: Procedure: LDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 retroperitoneal margin rate
R0 retroperitoneal margin rate diagnosed by postoperative pathological examination.
Measured: From the date of surgery to 1 month after surgery.
R0 transection margin rate
R0 transection margin rate diagnosed by postoperative pathological examination.
Measured: From the date of surgery to 1 month after surgery.
Lymph node positive rate
Lymph node positive rate diagnosed by postoperative pathological examination.
Measured: From the date of surgery to 1 month after surgery.
Secondary outcomes (4)
Perioperative complication rate
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.
Measured: Within 90 days after surgery.
Life quality satisfaction evaluated according to EORTC C30 scale
The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey and the EORTC C30 scales.
Measured: Through study completion, an average of 3 year.
Recurrence-free survival (RFS)
The time of surgery to the time of tumor recurrence or death.
Measured: Through study completion, an average of 3 year.
Overall survival (OS)
The time from the surgery to death from any cause.
Measured: Through study completion, an average of 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Oct 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Left-sided Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Soochow University, Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xianjun Yu, MD, PhD, Principal investigator, Fudan UniversityXiaowu Xu, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939063
- Sponsor's protocol ID
- CSPAC-6
- Status last verified
- Nov 2023
- First submitted
- 2 Jul 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30080726Asbun 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.
PubMed 31567509van 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.
PubMed 29099399Strasberg SM, Drebin JA, Linehan D. Radical antegrade modular pancreatosplenectomy. Surgery. 2003 May;133(5):521-7. doi: 10.1067/msy.2003.146.
PubMed 12773980Strasberg 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.
PubMed 17254928Mitchem 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.
PubMed 22192922Takahashi 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.
PubMed 36088222Tang 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.
PubMed 35577311Zhang 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.
PubMed 33033915Wu 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.
PubMed 34609574Lee 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.
PubMed 24853839Sato 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.
PubMed 37249638Sutton 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.
PubMed 35403874Sivasanker M, Desouza A, Bhandare M, Chaudhari V, Goel M, Shrikhande SV. Radical antegrade modular pancreatosplenectomy for all pancreatic body and tail tumors: rationale and results. Langenbecks Arch Surg. 2019 Mar;404(2):183-190. doi: 10.1007/s00423-019-01763-4. Epub 2019 Feb 21.
PubMed 30790046
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05939063
- Acronym / sponsor ID
- CSPAC-6
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Soochow University, Qilu Hospital of Shandong University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRAMPS group | Active comparator | Procedure: LRAMPSPatients who meet the inclusion and exclusion criteria will undergo laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) surgery. |
| LDP group | Experimental | Procedure: LDPPatients who meet the inclusion and exclusion criteria will undergo laparoscopic distal pancreatosplecnectomy (LDP) surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Received neoadjuvant therapy.
- Presence of liver or other distant metastasis.
- Multifocal or recurrent disease.
- History of other malignancies.
- Simultaneously participating in other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LRAMPSFor 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. | Procedure or surgery | LRAMPS group |
| LDPFor 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. | Procedure or surgery | LDP group |
Primary outcome
R0 retroperitoneal margin rate
Time frame: From the date of surgery to 1 month after surgery.
R0 retroperitoneal margin rate diagnosed by postoperative pathological examination.
R0 transection margin rate
Time frame: From the date of surgery to 1 month after surgery.
R0 transection margin rate diagnosed by postoperative pathological examination.
Lymph node positive rate
Time frame: From the date of surgery to 1 month after surgery.
Lymph node positive rate diagnosed by postoperative pathological examination.
4 secondary outcomes
Perioperative complication rate
Time frame: Within 90 days after surgery.
Life quality satisfaction evaluated according to EORTC C30 scale
Time frame: Through study completion, an average of 3 year.
Recurrence-free survival (RFS)
Time frame: Through study completion, an average of 3 year.
Overall survival (OS)
Time frame: Through study completion, an average of 3 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 30080726de 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.
- Background: PubMed 31567509Asbun 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.
- Background: PubMed 29099399van 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.
- Background: PubMed 12773980Strasberg SM, Drebin JA, Linehan D. Radical antegrade modular pancreatosplenectomy. Surgery. 2003 May;133(5):521-7. doi: 10.1067/msy.2003.146.
- Background: PubMed 17254928Strasberg 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.
- Background: PubMed 22192922Mitchem 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.
- Background: PubMed 36088222Takahashi 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.
- Background: PubMed 35577311Tang 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.
- Background: PubMed 33033915Zhang 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.
- Background: PubMed 34609574Wu 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.
- Background: PubMed 24853839Lee 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.
- Background: PubMed 37249638Sato 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.
- Individual participant dataSharing planned: No
Related trials for Left-sided Pancreatic Cancer
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
Spleen Preservation Versus Splenectomy in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
Pancreatic Cancer, Pancreatectomy
Active, not recruitingObservational study
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
Pancreatic Cancer Resectable, Pancreatectomy
Not yet recruitingPhase 3
Neoadjuvant Treatment vs Upfront Surgery for Left-Sided Pancreatic Cancer
Pancreatic Cancer Resectable
Recruiting
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Pancreatectomy, Distal Pancreatectomy (DP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xianjun Yu, MD, PhD principal investigator
Fudan University
Xiaowu Xu, MD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LRAMPS and LDP in people with Left-sided Pancreatic Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, MD, PhD (+86-13801669875, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 retroperitoneal margin rate (time frame: From the date of surgery to 1 month after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05939063, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.