Clinical trial NCT02219529: Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases
Official title: Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Diseases,
Gastric Ulcer,
Gastric Polyps,
Early Gastric Cancer,
Chronic Gastritis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Nanfang Hospital, Southern Medical University
name: Chinese PLA General Hospital
name: General Hospital of Beijing PLA Military Region
name: Wuhan Union Hospital, China
name: Shandong Provincial Hospital
name: Peking Union Medical College Hospital
First posted: 2014-08-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients presented with gastric symptoms and ready for the first Upper GI endoscopy
* Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.
* Age of 18 years to 70 years

Exclusion Criteria:

* Patients with impaired bowel movement from ileus or organic digestive diseases
* Patients with known large and obstructing tumors of the upper GI tract
* Patients after upper GI surgery or abdominal surgery altering GI anatomy
* Patients under full anticoagulation
* Patient in poor general condition
* Patients using equipment that may be affected by radio transmission
* Patients using equipment that may be affected by magnetic field
* Pregnancy or suspected pregnancy

Primary outcomes:
measure: Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
timeFrame: 2 days
measure: Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
timeFrame: 2 days
Secondary outcomes:
measure: Volume of water and drugs used for gastric preparation
timeFrame: 1 hour
measure: Scores of the cleanliness of stomach after preparation
timeFrame: 1 day
measure: Percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
timeFrame: 1 day
measure: Examination times of MCE and standard gastroscopy
timeFrame: 1 day
measure: Patient acceptance of MCE and standard gastroscopy
timeFrame: 3 days
measure: Adverse events of both procedures
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.
citation: Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031.
citation: Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.