- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03398941
The Effect of Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide on the Complications After Pancreatectomy. A Prospective, Multicenter Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on the clinicaltrail.gov.
Quality assurance plan: every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences.
Data check: the investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 70 participants to take part in the trail.
The investigators can recruit about 150 participants according to previous experiences.
Plan for missing data: the investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.
Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P < 0.05.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chen Yingtai, PhD
- Phone Number: +8618600258827
- Email: yingtai.chen@hotmail.com
Study Contact Backup
- Name: Zhao Yajie, PhD
- Phone Number: +8617319303256
- Email: zhaoyajielancet@qq.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contact:
- Chen Yingtai, PhD
- Phone Number: +8618600258827
- Email: yingtai.chen@hotmail.com
-
Contact:
- Zhao Yajie, PhD
- Phone Number: +8617319303256
- Email: zhaoyajielancet@163.com
-
Principal Investigator:
- Wang chengfeng, BA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pancreatectomy patients
Exclusion Criteria:
- Treated by chemotherapy or radiotherapy before With distant organ metastasis Cannot tolerate surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combined group
|
Long-Period Octreotide 20mg one week before operation combine Short Period Octreotide 0.3mg during postoperative five days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pancreatic fistula
Time Frame: three week after operation
|
three week after operation
|
delayed gastric emptying
Time Frame: three week after operation
|
three week after operation
|
intra-abdominal fluid collections
Time Frame: three week after operation
|
three week after operation
|
wound infection
Time Frame: three week after operation
|
three week after operation
|
Bile leak
Time Frame: three week after operation
|
three week after operation
|
Abdominal bleeding
Time Frame: three week after operation
|
three week after operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wang Chengfeng, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LC2017L01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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