Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03317886
Other study ID # 2128
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received October 18, 2017
Last updated October 21, 2017
Start date December 1, 2017
Est. completion date November 30, 2021

Study information

Verified date October 2017
Source Wakayama Medical University
Contact Seiko Hirono, M.D.,PhD
Phone +81-73-441-0613
Email seiko-h@wakayama-med.ac.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 during PD for PDAC.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 354
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
pancreaticoduodenectomy
pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

Locations

Country Name City State
Japan Kyusyu University Fukuoka
Japan Kansai Medical University Hirakata
Japan Hiroshima University Hiroshima
Japan Shimane University Izumo
Japan Kagoshima University Kagoshima
Japan Nara Medical University Kashihara
Japan Kumamoto University Kumamoto
Japan Nagoya University Nagoya
Japan Osaka Medical University Osaka
Japan Osaka University Osaka
Japan Shiga Medical University Otsu
Japan Kinki University Sayama
Japan Tokyo Medical University Tokyo
Japan Toyama University Toyama
Japan Wakayama Medical University Wakayama

Sponsors (1)

Lead Sponsor Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival survival from surgery to death up to 48 months
Secondary operative time time for operation up to 24 months
Secondary time for resection time for resection up to 3 months
Secondary intraoperative blood loss intraoperative blood loss volume up to 3 months
Secondary blood transfusion volume transfusion volume required during operation up to 3 months
Secondary grade B/C pancreatic fistula rate grade B/C pancreatic fistula rate according to International Study Group of Pancreatic Surgery (ISGPS) definition up to 3 months
Secondary rate of delayed gastric emptying rate of delayed gastric emptying according to International Study Group of Pancreatic Surgery (ISGPS) definition up to 3 months
Secondary abdominal hemorrhage rate abdominal hemorrhage rate according to International Study Group of Pancreatic Surgery (ISGPS) definition up to 3 months
Secondary all morbidity rate rate of all postoperative complications up to 3 months
Secondary mortality rate rate of operative death up to 3 months
Secondary diarrhea rate rate of postoperative rate up to 24 months
Secondary R0 rate pathological R0 rate up to 3 months
Secondary R1 rate pathological R1 rate up to 3 months
Secondary the closest length between surgical margin and cancer cell the closest length between surgical margin and cancer cell if R0 up to 3 months
Secondary number of harvested lymph nodes number of harvested lymph nodes up to 3 months
Secondary number of metastatic lymph nodes number of metastatic lymph nodes up to 3 months
Secondary lymph node ratio number of metastatic lymph nodes divided by number of harvested lymph nodes up to 3 months
Secondary recurrence free survival survival from operation date to recurrence date up to 24 months
Secondary site of initial recurrence site of initial recurrence up to 24 months
See also
  Status Clinical Trial Phase
Recruiting NCT05209074 - Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma Phase 1
Recruiting NCT04969731 - Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer Phase 3
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT05048524 - Peri-operative SLOG for Localized Pancreatic Cancer Phase 2
Terminated NCT04042480 - A Study of SGN-CD228A in Advanced Solid Tumors Phase 1
Completed NCT03257150 - A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer N/A
Terminated NCT04400903 - Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
Active, not recruiting NCT05462717 - Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Phase 1
Active, not recruiting NCT03267316 - A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors Phase 1/Phase 2
Recruiting NCT04970056 - Pancreatic Cancer Early Detection Consortium
Terminated NCT04046887 - Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC) Phase 1
Recruiting NCT05964621 - Venous Thromboembolism in Primary Pancreatic Tumour Resection
Active, not recruiting NCT04827953 - Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer Phase 1/Phase 2
Recruiting NCT04291651 - UCSF PANC Cyst Registry
Recruiting NCT05977322 - A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors. Phase 1
Recruiting NCT05692596 - The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Active, not recruiting NCT04853017 - A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors Phase 1
Active, not recruiting NCT04862260 - Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma Early Phase 1
Completed NCT03770117 - Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
Completed NCT02259114 - A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003) Phase 1