NCT02451384

Brief Summary

Acccording circulating tumor cells to compare the differences of different methods(routine method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of pancreatic body and tail.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 30, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

May 14, 2015

Last Update Submit

June 28, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • the changes of CTCs countings between the pre and post-operation in each arm

    Within 1 week after the surgeries are completed in any arm

  • the changes of CTCs countings between the pre and post-operation among the arms

    Within 2 weeks after the surgeies are all completed

Study Arms (3)

routine surgery

EXPERIMENTAL

In this arm the patients will be performed routine surgery to remove the tumors. And then we compare their circulating tumor cell countings in the pre and post-operation.

Procedure: routine surgery

no-touch surgery

EXPERIMENTAL

In this arm the patients will be performed no-touch surgery to remove the tumors. And then we compare their circulating tumor cells countings in the pre and post-operation.

Procedure: no-touch surgery

laparoscopy surgery

EXPERIMENTAL

In this arm the patients will be performed laparoscopy surgery to remove the tumors. And then we compare their circulating tumor cells countings in the pre and post-operation.

Procedure: laparoscopic surgery

Interventions

To observe if the surgeries can influence the countings of circulating tumor cells of the patients.

routine surgery
no-touch surgery
laparoscopy surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ductal adenocarcinoma of pancreatic body and tail
  • Tumor can be removed
  • No other tumors and without liver metastases
  • Age from 18 to 80 years old

You may not qualify if:

  • Neoplasms with other sites of the pancreas
  • With other tumors of any other sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Genaral surgery department of Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Pancreatic DuctalNeoplastic Cells, Circulating

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Carcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of General Surgery Department

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 22, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

June 30, 2015

Record last verified: 2015-06

Locations