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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398941
Recruitment Status : Unknown
Verified January 2018 by Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Pancreatic Diseases Drug: Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined group Drug: Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide
Long-Period Octreotide 20mg one week before operation combine Short Period Octreotide 0.3mg during postoperative five days.




Primary Outcome Measures :
  1. pancreatic fistula [ Time Frame: three week after operation ]
  2. delayed gastric emptying [ Time Frame: three week after operation ]
  3. intra-abdominal fluid collections [ Time Frame: three week after operation ]
  4. wound infection [ Time Frame: three week after operation ]
  5. Bile leak [ Time Frame: three week after operation ]
  6. Abdominal bleeding [ Time Frame: three week after operation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pancreatectomy patients

Exclusion Criteria:

  • Treated by chemotherapy or radiotherapy before With distant organ metastasis Cannot tolerate surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398941


Contacts
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Contact: Chen yingtai, PhD +8618600258827 yingtai.chen@hotmail.com
Contact: Zhao Yajie, PhD +8617319303256 zhaoyajielancet@qq.com

Locations
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China
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, China
Contact: Chen Yingtai, PhD    +8618600258827    yingtai.chen@hotmail.com   
Contact: Zhao Yajie, PhD    +8617319303256    zhaoyajielancet@163.com   
Principal Investigator: Wang chengfeng, BA         
Sponsors and Collaborators
Chengfeng Wang
Investigators
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Principal Investigator: Wang Chengfeng, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03398941    
Other Study ID Numbers: LC2017L01
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Pancreatic fistula
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents