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Pancreatic CancerMIRRORNCT03770559

The Therapeutic Evaluation(Both Short-term and Long-term Outcome) of Minimal Invasive Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer Patients

A study testing Minimal Invasive RAMPS and Open RAMPS in people with Pancreatic Cancer and Surgery, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pancreatic cancer is regarded as "the king of cancer". It is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Surgery
What is being tested?
Minimal Invasive RAMPS and Open RAMPS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteChina
Study dates
1 Jul 2020to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old and older;
  • Pathology diagnosed as pancreatic adenocarcinoma or suspect cancer mass at the pancreatic body or tail;
  • Patients who are eligible and planned to be performed RAMPS procedure;
  • Resectable or borderline resectable tumor by preoperative evaluation.

Who cannot join

  • Patients with evidence of distant metastasis or advanced arterial invasion so that are not able to continue radical surgery;
  • ASA≥4；
  • Patients who are not willing to be performed open and/or mi-RAMPS;
  • Not pancreatic adenocarcinoma by posteroperative pathology.

Trial locations and contacts

1 site in 1 country.

HANYU ZHANG, M.D. contact

01069152600

medzhy5813@126.com

Yatong Li, M.D. contact

861069155992

medzhy5813@126.com

China1 site, 1 recruiting

  • Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

    Beijing, 100730

    Menghua Dai, M.D., daimh@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: Minimal Invasive Versus Open Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer: a Randomized Controlled Trial

Pancreatic cancer is regarded as "the king of cancer". It is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Radical antegrade modular pancreatosplenectomy (RAMPS) is a standard method for treating pancreatic cancer at the body and tail of pancreas. In the same surgical approach, the investigators are going to compare and discuss the advantages of laparoscopic and open RAMPS in the RCT study.

Read the detailed description

Open RAMPS is widely used now to treat pancreatic cancer at the body and tail of pancreas. Meanwhile, laparoscopic surgery is proved to have many advantages in other operations. According to primary retrospective study of open and laparoscopic RAMPS, there was no statistically significant difference in the long-term follow-up situations between these two groups, indicating the safety of both this two surgical approaches. The investigators would like to promote a prospective RCT study, to give more evidences of the superiority of laparoscopic RAMPS.

Being tested
Minimal Invasive RAMPS, Open RAMPS
Keywords
Radical Antegrade Modular Pancreatosplenectomy(RAMPS), Pancreatic Cancer, Minimal Invasive, ERAS, Disease Free Survival
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimal Invasive RAMPSProcedure or surgery

    Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery

  • Open RAMPSProcedure or surgery

    Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery

Study groups in NCT03770559
Study groupRoleWhat they receive
Open-RAMPSActive comparatorPatients with pancreatic cancer treated by traditional open surgery
Receives: Procedure: Open RAMPS
MI-RAMPSExperimentalPatients with pancreatic cancer treated by laparoscopic surgery
Receives: Procedure: Minimal Invasive RAMPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Posteroperative length of stay

    The days between the postoperative day-1 to the date when patient was eligible to be discharged.

    Measured: Until patients were discharged

Secondary outcomes (7)

  1. Overall Survival

    DFS means the survival duration after surgery.

    Measured: more than 1 year

  2. Operative time

    Durtion of operation

    Measured: during the surgery

  3. Estimated blood loss

    blood loss volume during the operation

    Measured: During the surgery

  4. Postoperative pain

    VAS score to measure the degree of postoperative pain

    Measured: Until patients were discharged

  5. III-IV grade postoperative complication rate

    The ratio between patients with complication(s) and total patients in each groups.

    Measured: No less than 3 months.

  6. Disease Free Survival

    DFS means the survival duration after surgery without any evidence of recurrence and metastasis.

    Measured: more than 1 year

  7. R0 resection

    the margin status of resection specimen

    Measured: up to approximately 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2018
  2. Study start1 Jul 2020
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

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
Model description
The development of study model was divided into 2 parrallel groups( Minimal Invasive RAMPS vs. Open RAMPS) based on the certain surgical procedure underwent
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03770559
Sponsor's protocol ID
daimh-RAMPS
Other IDs
No.2020-1-4011
Acronym
MIRROR
Status last verified
May 2022
First submitted
24 Nov 2018
Last updated
20 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD is not avaiable, but statistical data is avaiable

Publications

  • Harrison LE, Klimstra DS, Brennan MF. Isolated portal vein involvement in pancreatic adenocarcinoma. A contraindication for resection? Ann Surg. 1996 Sep;224(3):342-7; discussion 347-9. doi: 10.1097/00000658-199609000-00010.

    PubMed 8813262

  • Jimenez RE, Warshaw AL, Rattner DW, Willett CG, McGrath D, Fernandez-del Castillo C. Impact of laparoscopic staging in the treatment of pancreatic cancer. Arch Surg. 2000 Apr;135(4):409-14; discussion 414-5. doi: 10.1001/archsurg.135.4.409.

    PubMed 10768705

  • 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.

    PubMed 22192922

  • Ome Y, Hashida K, Yokota M, Nagahisa Y, Michio O, Kawamoto K. Laparoscopic radical antegrade modular pancreatosplenectomy for left-sided pancreatic cancer using the ligament of Treitz approach. Surg Endosc. 2017 Nov;31(11):4836-4837. doi: 10.1007/s00464-017-5561-6. Epub 2017 Apr 13.

    PubMed 28409377

  • Cao F, Li J, Li A, Li F. Radical antegrade modular pancreatosplenectomy versus standard procedure in the treatment of left-sided pancreatic cancer: A systemic review and meta-analysis. BMC Surg. 2017 Jun 5;17(1):67. doi: 10.1186/s12893-017-0259-1.

    PubMed 28583142

  • 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.

    PubMed 17254928

  • Park HJ, You DD, Choi DW, Heo JS, Choi SH. Role of radical antegrade modular pancreatosplenectomy for adenocarcinoma of the body and tail of the pancreas. World J Surg. 2014 Jan;38(1):186-93. doi: 10.1007/s00268-013-2254-8.

    PubMed 24166024

  • Dai M, Zhang H, Yang Y, Xiu D, Peng B, Sun B, Cao F, Wu Z, Wang L, Yuan C, Chen H, Wang Z, Tian X, Wang H, Liu W, Xu J, Liu Q, Zhao Y. The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol. Front Oncol. 2022 Sep 15;12:965508. doi: 10.3389/fonc.2022.965508. eCollection 2022.

    PubMed 36185308

Questions about this trial

What is this clinical trial studying?

A study testing Minimal Invasive RAMPS and Open RAMPS in people with Pancreatic Cancer and Surgery, run by Peking Union Medical College Hospital 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact HANYU ZHANG, M.D. (01069152600, medzhy5813@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Posteroperative length of stay (time frame: Until patients were discharged). 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 NCT03770559, which also lists 8 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 20 May 2022.

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