Divestment for Artery-involved Pancreatic Cancer

February 18, 2018 updated by: Yi Miao, The First Affiliated Hospital with Nanjing Medical University

Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial

Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival.

Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.

Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT&MRI scan and tumor markers;
  2. Age > 18 year and <80 year;
  3. Agree to participate in the study with signed informed consent.

Exclusion Criteria:

  1. Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
  2. Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
  3. Focal vessel narrowing or contour irregularity revealed by radiology examinations;
  4. Economic situations cannot afford designed treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery Group
In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status.
Procedure: Artery Divestment Technique
Tunica adventitia was pick up by forceps and opened by electrocoagulation at 1 cm distal from tumor-artery contact. Space between tunica adventitia and external elastic lamina (EEL) were blunt lifting tumor-invaded adventitia by angled clamp. Adventitia was then sectioned to show EEL. Loose dissect space could be achieve along long the plane between EEL and adventitia as long as tumor invasion outside EEL. Tumor and invaded adventitia were further cut open by electrocoagulation proximally. Circumferentially, separation could be done by blunt dissection around EEL. Nourishing blood vessels of the artery would be secured by electrocoagulation or ultrasonic scalpel while major branch would be ligated or transfixed.
Other Names:
  • Sub-adventitial Resection
Active Comparator: NeoChemo Group
In NeoChemo (Neoadjuvant Chemotherapy) Group, neoadjuvant chemotherapy will be utilized. After 2 circles of neoadjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.
Drug: Nab-paclitaxel
After eligibility testing as blood tests, contrast-enhanced CT and MRI scan, 3 cycles were administered (1,000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel on days 1, 8, and 15 every 28 days).Patients will be reevaluated and curative operation would be attempted if without disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall mortality at one year after randomization;
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 years
3 years
Overall survival rate after 2 years from randomization;
Time Frame: 2 years
2 years
Overall survival rate after 3 years from randomization;
Time Frame: 3 years
3 years
Median survival
Time Frame: 3 years
3 years
Margin status of subjects receiving curative surgery
Time Frame: 1 years
The margin status will be reported as R0, R1 and R2 according to AJCC Cancer Staging Manual 8th ed.
1 years
Intra-operative blood transfusion
Time Frame: 1 years
For both Surgery Group and participants who received operations in NeoChemo Group, category and volume of intra-operative blood transfusion will be reported.
1 years
Intra-operative blood loss
Time Frame: 1 years
For both Surgery Group and participants who received operations in NeoChemo Group, intra-operative blood loss will be measured and reported by milliliter.
1 years
Overall surgical complication rate
Time Frame: 1 years
Overall surgical complication rate for both Surgery Group and participants who received operations in NeoChemo Group will be reported. Post-operative pancreatic fistula, delayed gastric emptying, post-operative hemorrhage, Surgical site infection and other surgical complications will be recorded. Percentage that candidates suffered from surgical complications of surgical cases for both group will be reported.
1 years
Incidence of post-operative pancreatic fistula
Time Frame: 1 years
Post-operative pancreatic fistula (POPF) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of post-operative pancreatic fistula of surgical cases in both group will be reported.
1 years
Incidence of delayed gastric emptying
Time Frame: 1 years
Delayed gastric emptying (DGE) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of DGE of surgical cases in both group will be reported.
1 years
Incidence of post-operative hemorrhage
Time Frame: 1 years
Post-operative hemorrhage (POH) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of POH of surgical cases in both group will be reported.
1 years
Incidence of surgical site infection
Time Frame: 1 years
Surgical site infection was assessed as US CDC guidelines.Incidence of surgical site infection of surgical cases in both group will be reported.
1 years
Incidence of other surgical complications
Time Frame: 1 years
Any other undesirable situations that considered complicated with surgery will be recorded. Incidence of other surgical complications of surgical cases in both group will be reported.
1 years
Severe adverse events rate
Time Frame: 3 years
Feasibility of chemotherapy will be evaluated according to Common Terminology Criteria for Adverse Events, US NCI. Participants receiving neo-adjuvant, adjuvant or palliative chemotherapy will be accessed. Grade 3-5 adverse events, dose reduction or dose delay will be reported.
3 years
Quality of life at 0.5 year after randomization
Time Frame: 0.5 year
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
0.5 year
Quality of life at 1 year after randomization
Time Frame: 1 year
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
1 year
Quality of life at 2 years after randomization
Time Frame: 2 years
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
2 years
Quality of life at 3 years after randomization
Time Frame: 3 years
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
3 years
Performance status at 0.5 year after randomization
Time Frame: 0.5 year
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
0.5 year
Performance status at 1 year after randomization
Time Frame: 1 year
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
1 year
Performance status at 2 years after randomization
Time Frame: 2 years
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
2 years
Performance status at 3 years after randomization
Time Frame: 3 years
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

December 17, 2017

First Submitted That Met QC Criteria

February 18, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 18, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-JSPH-PC-DIV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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