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Pancreatic Ductal AdenocarcinomaPhase 3NCT03317886

Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

A Phase 3 study testing pancreaticoduodenectomy in people with Pancreatic Ductal Adenocarcinoma and Pancreaticoduodenectomy, run by Wakayama Medical University at 15 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
pancreaticoduodenectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
15 sitesJapan
Study dates
1 Dec 2017to 30 Nov 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

Seiko Hirono, M.D.,PhD contact

+81-73-441-0613

seiko-h@wakayama-med.ac.jp

15 sites in 1 country

Japan15 sites

  • Kyusyu University

    Fukuoka

    Masafumi Nakamura

  • Kansai Medical University

    Hirakata

    Masanori Kon

    Sohei Satoi

  • Hiroshima University

    Hiroshima

    Yoshiaki Murakami

  • Shimane University

    Izumo

    Yoshitsugu Tajima

  • Kagoshima University

    Kagoshima

    Kousei Maemura

  • Nara Medical University

    Kashihara

    Masayuki Sho

  • Kumamoto University

    Kumamoto

    Hideo Baba

  • Nagoya University

    Nagoya

    Yasuhiro Kodera

    Suguru Yamada

  • Osaka Medical University

    Osaka

    Ryosuke Amano

  • Osaka University

    Osaka

    Hidetoshi Eguchi

  • Shiga Medical University

    Ōtsu

  • Kinki University

    Sayama

    Ippei Matsumoto

  • Tokyo Medical University

    Tokyo

    Yuichi Nagakawa

  • Toyama University

    Toyama

    Tsutomu Fujii

  • Wakayama Medical University

    Wakayama, 641-8510

    Hiroki Yamaue, M.D., PhD, +81-73-441-0613, yamaue-h@wakayama-med.ac.jp

    Seiko Hirono, M.D., PhD

Other trials in Japan

About this study

Official title: Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer During Pancreaticoduodenectomy (MAPLE-PD Trial)

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.

Read the 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.

Being tested
pancreaticoduodenectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pancreaticoduodenectomyProcedure or surgery

    pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

Study groups in NCT03317886
Study groupRoleWhat they receive
mesenteric approachActive comparatormesenteric approach starts from lymph node dissection around the superior mesenteric artery and performs Kocher's maneuver finally during pancreaticoduodenectomy.
Receives: Procedure: pancreaticoduodenectomy
conventional approachActive comparatorConventional approach starts from Kocher's maneuver and finally performs lymph node dissection around the superior mesenteric artery during pancreaticoduodenectomy.
Receives: Procedure: pancreaticoduodenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    survival from surgery to death

    Measured: up to 48 months

Secondary outcomes (18)

  1. operative time

    time for operation

    Measured: up to 24 months

  2. time for resection

    time for resection

    Measured: up to 3 months

  3. intraoperative blood loss

    intraoperative blood loss volume

    Measured: up to 3 months

  4. blood transfusion volume

    transfusion volume required during operation

    Measured: up to 3 months

  5. grade B/C pancreatic fistula rate

    grade B/C pancreatic fistula rate according to International Study Group of Pancreatic Surgery (ISGPS) definition

    Measured: up to 3 months

  6. rate of delayed gastric emptying

    rate of delayed gastric emptying according to International Study Group of Pancreatic Surgery (ISGPS) definition

    Measured: up to 3 months

  7. abdominal hemorrhage rate

    abdominal hemorrhage rate according to International Study Group of Pancreatic Surgery (ISGPS) definition

    Measured: up to 3 months

  8. all morbidity rate

    rate of all postoperative complications

    Measured: up to 3 months

  9. mortality rate

    rate of operative death

    Measured: up to 3 months

  10. diarrhea rate

    rate of postoperative rate

    Measured: up to 24 months

  11. R0 rate

    pathological R0 rate

    Measured: up to 3 months

  12. R1 rate

    pathological R1 rate

    Measured: up to 3 months

  13. the closest length between surgical margin and cancer cell

    the closest length between surgical margin and cancer cell if R0

    Measured: up to 3 months

  14. number of harvested lymph nodes

    number of harvested lymph nodes

    Measured: up to 3 months

  15. number of metastatic lymph nodes

    number of metastatic lymph nodes

    Measured: up to 3 months

  16. lymph node ratio

    number of metastatic lymph nodes divided by number of harvested lymph nodes

    Measured: up to 3 months

  17. recurrence free survival

    survival from operation date to recurrence date

    Measured: up to 24 months

  18. site of initial recurrence

    site of initial recurrence

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start1 Dec 2017 (estimated)
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion30 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
354 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03317886
Sponsor's protocol ID
2128
Status last verified
Oct 2017
First submitted
18 Oct 2017
Last updated
24 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hirono S, Kitahata Y, Motobayashi H, Satoi S, Sho M, Takami H, Kamei K, Shibuya K, Hidaka M, Uemura K, Kimura K, Mataki Y, Nagakawa Y, Hayashi H, Morimura R, Nakamura M, Wan K, Shimokawa T, Nakao A, Yamaue H; MAPLE-PD trial investigators. Mesenteric Versus Conventional Approach During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma (MAPLE-PD trial): A Multicenter Randomized Controlled Trial. Ann Surg. 2026 Apr 1;283(4):581-592. doi: 10.1097/SLA.0000000000006900. Epub 2025 Aug 7.

    PubMed 40772617

  • Hirono S, Kawai M, Okada KI, Fujii T, Sho M, Satoi S, Amano R, Eguchi H, Mataki Y, Nakamura M, Matsumoto I, Baba H, Tani M, Kawabata Y, Nagakawa Y, Yamada S, Murakami Y, Shimokawa T, Yamaue H. MAPLE-PD trial (Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer during Pancreaticoduodenectomy): study protocol for a multicenter randomized controlled trial of 354 patients with pancreatic ductal adenocarcinoma. Trials. 2018 Nov 8;19(1):613. doi: 10.1186/s13063-018-3002-z.

    PubMed 30409152

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pancreaticoduodenectomy in people with Pancreatic Ductal Adenocarcinoma and Pancreaticoduodenectomy, run by Wakayama Medical University at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Seiko Hirono, M.D.,PhD (+81-73-441-0613, seiko-h@wakayama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03317886, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.

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