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Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03317886
Recruitment Status : Not yet recruiting
First Posted : October 23, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Hiroki Yamaue, Wakayama Medical University

Brief Summary:
The aim of this study is to evaluate the advantage of mesenteric approach during pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC). The design of this study is multicenter randomized clinical trial, comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Pancreaticoduodenectomy Mesenteric Approach Procedure: pancreaticoduodenectomy Phase 3

Detailed Description:
Mesenteric approach starts from dissection of lymph nodes around the superior mesenteric artery (SMA) and finally performs Kocher's maneuver during PD. The aims of this approach are 1) decrease of intraoperative blood loss volume, 2) increase of R0 rate, and 3) prevention of squeezing cancer cells out into the vessels. However, there have been no evidence of the efficacy of this procedure. Therefore, the aim of this study is to evaluate the efficacy of mesenteric approach during PD for PDAC, by multicenter randomized clinical trial comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer During Pancreaticoduodenectomy (MAPLE-PD Trial)
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: mesenteric approach
mesenteric approach starts from lymph node dissection around the superior mesenteric artery and performs Kocher's maneuver finally during pancreaticoduodenectomy.
Procedure: pancreaticoduodenectomy
pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

Active Comparator: conventional approach
Conventional approach starts from Kocher's maneuver and finally performs lymph node dissection around the superior mesenteric artery during pancreaticoduodenectomy.
Procedure: pancreaticoduodenectomy
pancreaticoduodenectomy for pancreatic ductal adenocarcinoma




Primary Outcome Measures :
  1. overall survival [ Time Frame: up to 48 months ]
    survival from surgery to death


Secondary Outcome Measures :
  1. operative time [ Time Frame: up to 24 months ]
    time for operation

  2. time for resection [ Time Frame: up to 3 months ]
    time for resection

  3. intraoperative blood loss [ Time Frame: up to 3 months ]
    intraoperative blood loss volume

  4. blood transfusion volume [ Time Frame: up to 3 months ]
    transfusion volume required during operation

  5. grade B/C pancreatic fistula rate [ Time Frame: up to 3 months ]
    grade B/C pancreatic fistula rate according to International Study Group of Pancreatic Surgery (ISGPS) definition

  6. rate of delayed gastric emptying [ Time Frame: up to 3 months ]
    rate of delayed gastric emptying according to International Study Group of Pancreatic Surgery (ISGPS) definition

  7. abdominal hemorrhage rate [ Time Frame: up to 3 months ]
    abdominal hemorrhage rate according to International Study Group of Pancreatic Surgery (ISGPS) definition

  8. all morbidity rate [ Time Frame: up to 3 months ]
    rate of all postoperative complications

  9. mortality rate [ Time Frame: up to 3 months ]
    rate of operative death

  10. diarrhea rate [ Time Frame: up to 24 months ]
    rate of postoperative rate

  11. R0 rate [ Time Frame: up to 3 months ]
    pathological R0 rate

  12. R1 rate [ Time Frame: up to 3 months ]
    pathological R1 rate

  13. the closest length between surgical margin and cancer cell [ Time Frame: up to 3 months ]
    the closest length between surgical margin and cancer cell if R0

  14. number of harvested lymph nodes [ Time Frame: up to 3 months ]
    number of harvested lymph nodes

  15. number of metastatic lymph nodes [ Time Frame: up to 3 months ]
    number of metastatic lymph nodes

  16. lymph node ratio [ Time Frame: up to 3 months ]
    number of metastatic lymph nodes divided by number of harvested lymph nodes

  17. recurrence free survival [ Time Frame: up to 24 months ]
    survival from operation date to recurrence date

  18. site of initial recurrence [ Time Frame: up to 24 months ]
    site of initial recurrence



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient who are scheduled to undergo pancreaticoduodenectomy for resectable or borderline resectable (only portal vein invasion) pancreatic ductal adenocarcinoma.
  2. Patients whose Eastern Cooperative Oncology Group performance status are 0 or 1.
  3. Patients who are 20 years or older.
  4. Patients who have adequate organ function.
  5. Patients who understand sufficiently the study to provide written informed consent

Exclusion Criteria:

  1. Patients who have severe ischemic cardiovascular disease
  2. Patients who have liver cirrhosis or active hepatitis
  3. Patients who need oxygen due to interstitial pneumonia or lung fibrosis
  4. Patients who receive dialysis due to chronic renal failure
  5. Patients who need surrounding organ resection
  6. Patients who need artery reconstruction
  7. Patients who are diagnosed as positive para-aortic lymph node metastases based on preoperative imaging
  8. Patients who have active multiple cancer that is thought to influence the occurrence of adverse events
  9. Patients who take steroid for the long period that is thought to influence the occurrence of adverse events
  10. Patients who undergo laparoscopic or laparoscopy-assisted pancreaticoduodenectomy
  11. Patients who cannot understand ths study due to psychotic disease or psychological symptoms
  12. Patients whose preoperative biopsy tissues are diagnosed as other pathological findings than pancreatic ductal adenocarcinoma
  13. Patients who underwent gastrectomy or colon/ rectum resection previously
  14. Patients who have severe drug allergy to iodine and gadolinium

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): NCT03317886


Contacts
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Contact: Seiko Hirono, M.D.,PhD +81-73-441-0613 seiko-h@wakayama-med.ac.jp

Locations
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Japan
Kyusyu University Not yet recruiting
Fukuoka, Japan
Contact: Masafumi Nakamura         
Kansai Medical University Not yet recruiting
Hirakata, Japan
Contact: Masanori Kon         
Sub-Investigator: Sohei Satoi         
Hiroshima University Not yet recruiting
Hiroshima, Japan
Contact: Yoshiaki Murakami         
Shimane University Not yet recruiting
Izumo, Japan
Contact: Yoshitsugu Tajima         
Kagoshima University Not yet recruiting
Kagoshima, Japan
Contact: Kousei Maemura         
Nara Medical University Not yet recruiting
Kashihara, Japan
Contact: Masayuki Sho         
Kumamoto University Not yet recruiting
Kumamoto, Japan
Contact: Hideo Baba         
Nagoya University Not yet recruiting
Nagoya, Japan
Contact: Yasuhiro Kodera         
Sub-Investigator: Suguru Yamada         
Osaka Medical University Not yet recruiting
Osaka, Japan
Contact: Ryosuke Amano         
Osaka University Not yet recruiting
Osaka, Japan
Contact: Hidetoshi Eguchi         
Shiga Medical University
Otsu, Japan
Kinki University Not yet recruiting
Sayama, Japan
Contact: Ippei Matsumoto         
Tokyo Medical University Not yet recruiting
Tokyo, Japan
Contact: Yuichi Nagakawa         
Toyama University Not yet recruiting
Toyama, Japan
Contact: Tsutomu Fujii         
Wakayama Medical University Not yet recruiting
Wakayama, Japan, 641-8510
Contact: Hiroki Yamaue, M.D., PhD    +81-73-441-0613    yamaue-h@wakayama-med.ac.jp   
Sub-Investigator: Seiko Hirono, M.D., PhD         
Sub-Investigator: Manabu Kawai, M.D., PhD         
Sub-Investigator: Ken-ichi Okada, M.D., PhD         
Sub-Investigator: Motoki Miyazawa, M.D., PhD         
Sub-Investigator: Yuji Kitahata, M.D., PhD         
Sub-Investigator: Ryohei Kobayashi, M.D., PhD         
Sub-Investigator: Mariko Doi, PhD         
Sub-Investigator: Toshio Shimokawa, PhD         
Principal Investigator: Hiroki Yamaue, M.D., PhD         
Sponsors and Collaborators
Wakayama Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hiroki Yamaue, Professor, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT03317886     History of Changes
Other Study ID Numbers: 2128
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms