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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398941
• Other study ID #: LC2017L01
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2018
• Last updated: January 7, 2018
• Start date: February 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: January 2018
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Chen yingtai, PhD
• Phone: +8618600258827
• Email: yingtai.chen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pancreatectomy patients

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pancreatic Diseases

Intervention

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.

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chengfeng Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic fistula		three week after operation
Primary	delayed gastric emptying		three week after operation
Primary	intra-abdominal fluid collections		three week after operation
Primary	wound infection		three week after operation
Primary	Bile leak		three week after operation
Primary	Abdominal bleeding		three week after operation