Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

RAMPS VS SRPS for Pancreatic Body and Tail Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253847
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Yuanchi Weng, Ruijin Hospital

Brief Summary:
Two arms RCT is design, patients with pancreatic body or tail adenocarcinoma will be randomly assigned to the Radical Antegrade Modular Pancreaticosplenectomy (RAMPS) group or Standard Retrograde Pancreatosplenectomy (SRPS) group. The primary objective is to evaluate the effect of RAMPS on the overall survival of patients with resectable body and tail pancreatic ductal adenocarcinoma. And the secondary objective is to evaluate the disease-free survival, R0 resection rate, number of retrieved lymph nodes and perioperative outcomes like postoperative complication rate, severe complications, mortality and functional recovery time between the experimental group and control group.

Condition or disease Intervention/treatment Phase
Radical Antegrade Modular Pancreatosplenectomy Procedure: Radical antegrade modular pancreatosplenectomy Procedure: Standard retrograde pancreatosplenectomy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The participant will not know which group they are assigned to, but the surgeons know which group they were randomly assigned to.
Primary Purpose: Treatment
Official Title: Radical Antegrade Modular Pancreatosplenectomy Versus Standard Retrograde Pancreatosplenectomy on the Survival and Prognosis for Resectable Body and Tail Pancreatic Ductal Adenocarcinoma
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2027

Arm Intervention/treatment
Experimental: RAMPS group
Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.
Procedure: Radical antegrade modular pancreatosplenectomy
Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.

Active Comparator: SRPS group
Standard retrograde pancreatosplenectomy(SRPS) includes several key points. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
Procedure: Standard retrograde pancreatosplenectomy
Standard retrograde pancreatosplenectomy(SRPS) includes several aspects. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 21 months ]
    Overall survival was defined as the time from surgery to either death or last follow-up. Patients will be observed or contacted every 2 months in the first 2 years after surgery and then every 3 months thereafter. Overall survival measurement will be based on patient's survival status and what is the date of death if the patient is not alive.


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 11 months ]
    DFS was calculated from the date of surgery to the date of recurrence or last follow-up if recurrence did not occur. Recurrence was diagnosed by imaging examination like CT, MRI, PET-CT and PET-MRI.

  2. R0 resection rate [ Time Frame: 1 month ]
    R0 resection was defined as absence of malignant cells within 1 mm from the resection margin using the Royal College of Pathologists definition. The assessment of the margin status will be done by pathologists.

  3. retrieved lymph nodes [ Time Frame: 1 month ]
    The dissected lymph nodes will be sent to pathology department and the pathologists will separate the lymph nodes and give reports about how many lymph nodes are found and if the lymph nodes are positive or negative.


Other Outcome Measures:
  1. operation time in minutes [ Time Frame: 1 day ]
    Operation time means "skin to skin"time (from the surgeon start to incise the skin to the last suture of the skin)

  2. estimated blood loss in milliliters [ Time Frame: 1 day ]
    Estimated blood loss will be evaluated based on the vacuum amount, gauze weight and liquid intake

  3. postoperative pancreatic fistula in percentage [ Time Frame: 3 months ]
    According to the definition of International Study Group on Pancreatic Fistula(ISGPF)

  4. postpancreatectomy hemorrhage in percentage [ Time Frame: 3 months ]
    Postpancreatectomy hemorrhage is defined by International Study Group on Pancreatic Surgery

  5. delayed gastric emptying in percentage [ Time Frame: 3 months ]
    Delayed gastric emptying is defined by International Study Group on Pancreatic Surgery

  6. Surgical site infection in percentage [ Time Frame: 3 months ]
    Surgical site infections are defined by the Center for Disease Control and Prevention (CDC) definition, and diagnosed by positive pathogen culture in 2 weeks from surgery

  7. 30-day mortality in percentage [ Time Frame: 1 month ]
    Any death within 30 days in postoperative period will be calculated

  8. 90-day mortality in percentage [ Time Frame: 3 months ]
    Any death within 90 days in postoperative period will be calculated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 years old;
  • Resectable pancreatic body and tail ductal adenocarcinoma with both preoperative and intraoperative evaluation(refer to NCCN guideline 2018 of Pancreatic Cancer);
  • ECOG Performance Status 0-1;
  • Adenocarcinoma of pancreatic body and tail duct, without distant metastasis and ascites;
  • The estimated survival time is ≥ 3 months;
  • Follow-up in time and obey the research requirements;
  • Be voluntary to this clinical trial and can sign the informed consent;
  • Normal hematological index (Leukocyte, platelet, liver function, renal function, DIC, electrolyte index, Hb >10g/dL).

Exclusion Criteria:

  • The patients with distant metastasis according to preoperative tumor staging;
  • Patients with recurrent pancreatic ductal adenocarcinoma;
  • The artery or vein is involved and could not be resected or reconstructed(according to preoperative evaluation or intraoperative evaluation after exploration);
  • Patients with cardiopulmonary disfunction and cannot tolerate operation;
  • The patients accepted neoadjuvant chemotherapy and radiotherapy before operation;
  • Patients with other malignancies or hematopathy
  • Before the operation, the total bilirubin was more than 250 μmol/L without preoperative biliary drainage or after biliary drainage, the total bilirubin was still more than 250 μmol/L;
  • Pregnancy diagnosed, planned pregnancy and lactating female patients
  • Refusal to sign consent.
  • Intraoperative exclusion include:Tumor metastasis; not pancreatic primary disease; unresectable pancreatic body/tail adenocarcinoma
  • Postoperative exclusion include: not pancreatic ductal adenocarcinoma according to pathological examination.
  • Withdrawal of informed consent;
  • Willingness to withdraw from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253847


Contacts
Layout table for location contacts
Contact: Yuanchi Weng, MD +86-13774209138 wyuanchi@126.com
Contact: Zhen Huo, PhD +86-15000082925 generalsurgeon@qq.com

Locations
Layout table for location information
China, Shanghai
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200025
Contact: Yuanchi Weng, MD.    +86-13774209138    wyuanchi@126.com   
Contact: Zhen Huo, PhD    +86-15000082925    generalsurgeon@qq.com   
Sponsors and Collaborators
Ruijin Hospital
Layout table for additonal information
Responsible Party: Yuanchi Weng, Attending Physician, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04253847    
Other Study ID Numbers: HBP-RCT-005
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuanchi Weng, Ruijin Hospital:
Radical antegrade modular pancreatosplenectomy
Standard retrograde pancreatosplenectomy
Pancreatic Body and Tail Adenocarcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms