Pancreatic Diseases Clinical Trial
Official title:
The Effect of Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide on the Complications After Pancreatectomy. A Prospective, Multicenter Clinical Trial
The Effect of Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide on the Complications After Pancreatectomy. A Prospective, Multicenter Clinical Trial
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.
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