Perioperative Electroacupuncture After Operation

Acupuncture Clinical Trial

Official title:

Effect of Perioperative Electroacupuncture After Operation for Pancreatic Cancer and Periampullary Carcinoma Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03291561
• Other study ID #: CT20170730
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2017
• Last updated: September 21, 2017
• Start date: August 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2017
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Chengfeng Wang, B.A
• Phone: 861013811370062
• Email: lifeofwater[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the effect of perioperative electroacupuncture on rapid rehabilitation for the pancreatic cancer and periampullary carcinoma patients after operation .

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 400 participants to take part in the trail.

The investigators can recruit about 200 participants every year according to previous experiences, so the investigators should recruit at least for two years. 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: 400
• Est. completion date: December 31, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. gastric cancer with gastrectomy

2. less than 3 months life expectancy

3. voluntary and good compliance

Exclusion Criteria:

1. history of abdominal surgery, radiotherapy or chemotherapy

2. metastatic disease.

Related Conditions & MeSH terms

• Acupuncture
• Gastrointestinal Function

Intervention

Procedure:
• Electroacupuncture
Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.
• Sham electroacupuncture
Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal function score	Using scale to evaluate the function of gastrointestinal tract after surgery	day 1 after surgery
Primary	Gastrointestinal function score	Using scale to evaluate the function of gastrointestinal tract after surgery	day 3 after surgery
Primary	Gastrointestinal function score	Using scale to evaluate the function of gastrointestinal tract after surgery	day 5 after surgery
Primary	Gastrointestinal function score	Using scale to evaluate the function of gastrointestinal tract after surgery	day 7 after surgery
Secondary	Physical fitness index	The recovery of physical fitness index	day 1 after surgery
Secondary	Physical fitness index	The recovery of physical fitness index	day 3 after surgery
Secondary	Physical fitness index	The recovery of physical fitness index	day 5 after surgery
Secondary	Physical fitness index	The recovery of physical fitness index	day 7 after surgery