NCT03770559

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

November 24, 2018

Last Update Submit

May 18, 2022

Conditions

Pancreatic CancerSurgery

Keywords

Radical Antegrade Modular Pancreatosplenectomy(RAMPS)Pancreatic CancerMinimal InvasiveERASDisease Free Survival

Outcome Measures

Primary Outcomes (1)

  • Posteroperative length of stay

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

    Until patients were discharged

Secondary Outcomes (7)

  • Overall Survival

    more than 1 year

  • Operative time

    during the surgery

  • Estimated blood loss

    During the surgery

  • Postoperative pain

    Until patients were discharged

  • III-IV grade postoperative complication rate

    No less than 3 months.

  • +2 more secondary outcomes

Study Arms (2)

Open-RAMPS

ACTIVE COMPARATOR

Patients with pancreatic cancer treated by traditional open surgery

Procedure: Open RAMPS

MI-RAMPS

EXPERIMENTAL

Patients with pancreatic cancer treated by laparoscopic surgery

Procedure: Minimal Invasive RAMPS

Interventions

Minimal Invasive RAMPSPROCEDURE

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

MI-RAMPS
Open RAMPSPROCEDURE

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

Open-RAMPS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, 100730, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 8813262BACKGROUND

  • 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.

    PMID: 10768705BACKGROUND

  • 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: 22192922BACKGROUND

  • 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.

    PMID: 28409377BACKGROUND

  • 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.

    PMID: 28583142BACKGROUND

  • 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: 17254928BACKGROUND

  • 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.

    PMID: 24166024BACKGROUND

  • 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.

    PMID: 36185308DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Menghua Dai, M.D.

    PUMCH

    STUDY CHAIR

Central Study Contacts

HANYU ZHANG, M.D.

CONTACT

01069152600medzhy5813@126.com

Yatong Li, M.D.

CONTACT

861069155992medzhy5813@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The development of study model was divided into 2 parrallel groups( Minimal Invasive RAMPS vs. Open RAMPS) based on the certain surgical procedure underwent
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2018

First Posted

December 10, 2018

Study Start

July 1, 2020

Primary Completion

June 30, 2023

Study Completion

December 30, 2024

Last Updated

May 20, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

IPD is not avaiable, but statistical data is avaiable

Locations

CN(1)