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Perioperative Electroacupuncture for Gastric Cancer Patients After Gastrectomy

NCT ID: NCT03291574

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-29

Study Completion Date

2020-12-31

Brief Summary

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Evaluate the effect of Perioperative Electroacupuncture on rapid rehabilitation for the gastric cancer patients after gastrectomy .

Detailed Description

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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 35 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.

Conditions

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Acupuncture Gastrointestinal Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Electroacupuncture group

Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu

Group Type EXPERIMENTAL

Electroacupuncture

Intervention Type PROCEDURE

Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Sham electroacupuncture group

Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu

Group Type PLACEBO_COMPARATOR

Sham electroacupuncture

Intervention Type PROCEDURE

Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Interventions

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Electroacupuncture

Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Intervention Type PROCEDURE

Sham electroacupuncture

Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with gastric cancer who undergoing gastrectomy.
2. The life expectancy will be more than 3 months.
3. Voluntary participation, Signing informed consent and have good compliance.

Exclusion Criteria

1. Patient who has a history of abdominal surgery, radiotherapy, and chemotherapy.
2. Patient who combined with abdominal lymph node metastasis or distant organ metastasis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Chengfeng Wang

Director of Department of pancreatic and gastric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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chenefeng Wang, B.A

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chengfeng Wang, B.A

Role: CONTACT

[email protected]
8613811370062

Facility Contacts

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chengfeng Wang, B.A

Role: primary

[email protected]
8613811370062

References

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Qiu G, Huang T, Lu Y, Zhang L, Zhao Y, Yuan Y, Ren H, An J, Zhou J, Li R, Du Y, Wang T, Wang P, He F, Ding Y, Zhang J, Han B, Lan Z, Qi S, Li Z, Gao J, Gu Z, Sun Y, Bai X, Aimaiti S, Chu Y, Wang C. Perioperative Electroacupuncture Can Accelerate the Recovery of Gastrointestinal Function in Cancer Patients Undergoing Pancreatectomy or Gastrectomy: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2021 Mar 31;2021:5594263. doi: 10.1155/2021/5594263. eCollection 2021.

Reference Type DERIVED
PMID: 33859707 (View on PubMed)

Other Identifiers

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LC2015L45

Identifier Type: -

Identifier Source: org_study_id