Perioperative Electroacupuncture After Operation

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

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

Study Overview

• Status: Unknown
• Conditions: Acupuncture; Gastrointestinal Function
• Intervention / Treatment: Procedure: Electroacupuncture; Procedure: Sham electroacupuncture

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chengfeng Wang, B.A; Phone Number: 861013811370062; Email: lifeofwater@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10021
      • Recruiting
      • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Chengfeng Wang, B.A; Phone Number: 861013811370062; Email: lifeofwater@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electroacupuncture group; Electroacupuncture Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.	Procedure: Electroacupuncture; Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.
PLACEBO_COMPARATOR: Sham electroacupuncture group; Sham acupuncture at Baihui, Nei guan, bilateral Zu, sanli and bilateral Tian shu.	Procedure: Sham electroacupuncture; Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal function score	Using scale to evaluate the function of gastrointestinal tract after surgery	day 1 after surgery
Gastrointestinal function score	Using scale to evaluate the function of gastrointestinal tract after surgery	day 3 after surgery
Gastrointestinal function score	Using scale to evaluate the function of gastrointestinal tract after surgery	day 5 after surgery
Gastrointestinal function score	Using scale to evaluate the function of gastrointestinal tract after surgery	day 7 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical fitness index	The recovery of physical fitness index	day 1 after surgery
Physical fitness index	The recovery of physical fitness index	day 3 after surgery
Physical fitness index	The recovery of physical fitness index	day 5 after surgery
Physical fitness index	The recovery of physical fitness index	day 7 after surgery

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Chengfeng Wang, B.A, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: July 30, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (ACTUAL): September 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CT20170730

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No