Clinical trial NCT03770559: The Therapeutic Evaluation(Both Short-term and Long-term Outcome) of Minimal Invasive Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer Patients
Official title: Minimal Invasive Versus Open Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Surgery
Keywords: Radical Antegrade Modular Pancreatosplenectomy(RAMPS)
Pancreatic Cancer
Minimal Invasive
ERAS
Disease Free Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Health Commission
First posted: 2018-12-10
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Posteroperative length of stay
timeFrame: Until patients were discharged
Secondary outcomes:
measure: Overall Survival
timeFrame: more than 1 year
measure: Operative time
timeFrame: during the surgery
measure: Estimated blood loss
timeFrame: During the surgery
measure: Postoperative pain
timeFrame: Until patients were discharged
measure: III-IV grade postoperative complication rate
timeFrame: No less than 3 months.
measure: Disease Free Survival
timeFrame: more than 1 year
measure: R0 resection
timeFrame: up to approximately 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Study officials:
affiliation: PUMCH
name: Menghua Dai, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.