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

NCT ID: NCT03770559

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2024-12-30

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.

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.

Conditions

Pancreatic Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-RAMPS

Patients with pancreatic cancer treated by traditional open surgery

Group Type: ACTIVE_COMPARATOR

Open RAMPS

Intervention Type: PROCEDURE

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

MI-RAMPS

Patients with pancreatic cancer treated by laparoscopic surgery

Group Type: EXPERIMENTAL

Minimal Invasive RAMPS

Intervention Type: PROCEDURE

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

Interventions

Minimal Invasive RAMPS

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

Intervention Type: PROCEDURE

Open RAMPS

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 18 years old and older;

2. Pathology diagnosed as pancreatic adenocarcinoma or suspect cancer mass at the pancreatic body or tail;

3. Patients who are eligible and planned to be performed RAMPS procedure;

4. Resectable or borderline resectable tumor by preoperative evaluation.

Exclusion Criteria

1. Patients with evidence of distant metastasis or advanced arterial invasion so that are not able to continue radical surgery;

2. ASA≥4；

3. Patients who are not willing to be performed open and/or mi-RAMPS;

4. Not pancreatic adenocarcinoma by posteroperative pathology.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Health Commission

OTHER_GOV

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dai Menghua

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Menghua Dai, M.D.

Role: STUDY_CHAIR

PUMCH

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

HANYU ZHANG, M.D.

Role: CONTACT

medzhy5813@126.com

01069152600

Yatong Li, M.D.

Role: CONTACT

medzhy5813@126.com

861069155992

Facility Contacts

Menghua Dai, M.D.

Role: primary

daimh@pumch.cn

References

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.

Reference Type: BACKGROUND

PMID: 8813262 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10768705 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22192922 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28409377 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28583142 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17254928 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24166024 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36185308 (View on PubMed)

Other Identifiers

No.2020-1-4011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

daimh-RAMPS

Identifier Type: -

Identifier Source: org_study_id