According CTC to Compare the Influences of Different Methods to Remove the PDAC

Carcinoma, Pancreatic Ductal Clinical Trial

Official title:

To Compare the Influences of Different Methods to Remove the Pancreatic Ductal Adenocarcinoma With the Detection of Circulating Tumor Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02451384
• Other study ID #: B2015-010
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2015
• Last updated: June 28, 2015
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Neoplasms with other sites of the pancreas

• With other tumors of any other sites

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal
• Circulating Tumor Cells
• Neoplastic Cells, Circulating

Intervention

Procedure:
• routine surgery
To observe if the surgeries can influence the countings of circulating tumor cells of the patients.
• no-touch surgery

• laparoscopic surgery

Locations

Country	Name	City	State
China	Genaral surgery department of Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	the changes of CTCs countings between the pre and post-operation among the arms		Within 2 weeks after the surgeies are all completed	Yes