Mini-sized MCE for Better Examination of UGI and Small Bowel

Capsule Endoscopy Clinical Trial

Official title:

Feasibility of Mini-sized Magnetically Controlled Capsule Endoscopy in Visualization of UGI and Small Bowel: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05073536
• Other study ID #: mini-MCE
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: November 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A mini-sized MCE highlighted with a diameter of 9.5mm, a length of 24.5mm, and a weight of 3.0g has been developed. This new type of MCE is approximately 0.6 times the conventional MCE (27mm*11.8mm) in volume and weight, and it is the smallest CE among all the reported capsules. Thus, this pilot study was conducted to clarify whether the mini-sized MCE can further optimize the process of swallowing the capsule and to verify whether the smaller size of the capsule will have influence on the examination procedure of the upper gastrointestinal tract and small intestine.

Description:

Magnetically controlled capsule endoscopy (MCE), with equally favorable diagnostic accuracy as conventional endoscopy, has become a painless noninvasive diagnostic modality in clinical practice. The more than 8 hours battery life of the MCE enables a further examination of the small bowel. In addition, it has been demonstrated that magnetic steering of capsule endoscopy improves the completion rate of small bowel examination by facilitating passage of the capsule through the pylorus, which further supported MCE as a practical modality for examination of both the stomach and small bowel. Previous studies have confirmed the great safety and efficacy of MCE for examination of patients with high-risk factors for standard gastroscopy, those long-time taking aspirin, aging patients and children. However, this technique still has some limitations in clinical practice. Due to the large size of the capsule, some patients may be difficult to swallow the capsule, especially in children. A clinical trial reported that a certain number of children with ages ranging from 6 to 14 years fail to swallow the MCE by themselves for its big size (27mm*11.8mm). During the examination procedure of small bowel capsule endoscopy, measuring 26*11mm, in those under 10 years old of age, up to 87% of patients are unable to swallow the capsule. In adolescents, it is reported that more than one-third of patients have difficulties with swallowing standard size tablets. In addition, serious complications, such as aspiration of the capsule, often occur in the elderly who need more efforts to swallow the capsule. For those at any age unable or unwilling to swallow a capsule, endoscopic placement is required to deliver the capsule to the stomach or directly the duodenum. However, this procedure greatly increases patient's discomfort, examination costs and increase the risk associated with the endoscopic procedure, anesthesia. Thus, it is of great importance to make the capsule endoscopy easier to swallow in both children and adolescents. Therefore, a mini-sized MCE highlighted with a diameter of 9.5mm, a length of 24.5mm, and a weight of 3.0g has been developed. This new type of MCE is approximately 0.6 times the conventional MCE (27mm*11.8mm) in volume and weight, and it is the smallest CE among all the reported capsules. Thus, this pilot study was conducted to clarify whether the mini-sized MCE can further optimize the process of swallowing the capsule and to verify whether the smaller size of the capsule will have influence on the examination procedure of the upper gastrointestinal tract and small intestine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 15, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients aged =18.
• Scheduled to undergo a capsule endoscopy for both stomach and small bowel.
• Signed the informed consents before joining this study.

Exclusion Criteria:

• Dysphagia or symptoms of gastric outlet obstruction
• Known or suspected GI obstruction, stenosis, or fistula
• History of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
• Implanted pacemaker, except the pacemaker is compatible with MRI
• Other implanted electromedical devices or magnetic metal foreign bodies
• Pregnancy or suspected pregnancy

Related Conditions & MeSH terms

• Capsule Endoscopy

Intervention

Device:
• mini-sized MCE
Enrolled participants were randomly allocated into the normal-sized MCE group or mini-sized MCE group in a 1:1 ratio.
• normal-sized MCE
Enrolled participants were randomly allocated into the normal-sized MCE group or mini-sized MCE group in a 1:1 ratio.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Changhai Hospital	Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (8)

Dan T, Dandan S, Enqiang L. Aspiration of a magnetically controlled capsule endoscopy. Gastroenterology. 2019 Apr 11. pii: S0016-5085(19)35686-0. doi: 10.1053/j.gastro.2019.04.006. [Epub ahead of print] — View Citation

Hu J, Wang S, Ma W, Pan D, Sun S. Magnetically controlled capsule endoscopy as the first-line examination for high-risk patients for the standard gastroscopy: a preliminary study. Scand J Gastroenterol. 2019 Jul;54(7):934-937. doi: 10.1080/00365521.2019.1638446. Epub 2019 Jul 22. — View Citation

Jiang X, Pan J, Li ZS, Liao Z. Standardized examination procedure of magnetically controlled capsule endoscopy. VideoGIE. 2019 May 30;4(6):239-243. doi: 10.1016/j.vgie.2019.03.003. eCollection 2019 Jun. — View Citation

Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11. — View 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. — View Citation

Liao Z, Zou W, Li ZS. Clinical application of magnetically controlled capsule gastroscopy in gastric disease diagnosis: recent advances. Sci China Life Sci. 2018 Nov;61(11):1304-1309. doi: 10.1007/s11427-018-9353-5. Epub 2018 Oct 18. Review. — View Citation

Nuutinen H, Kolho KL, Salminen P, Rintala R, Koskenpato J, Koivusalo A, Sipponen T, Färkkilä M. Capsule endoscopy in pediatric patients: technique and results in our first 100 consecutive children. Scand J Gastroenterol. 2011 Sep;46(9):1138-43. doi: 10.3109/00365521.2011.584900. Epub 2011 May 26. — View Citation

Patel A, Jacobsen L, Jhaveri R, Bradford KK. Effectiveness of pediatric pill swallowing interventions: a systematic review. Pediatrics. 2015 May;135(5):883-9. doi: 10.1542/peds.2014-2114. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difficulty score for swallowing the capsule	The primary outcome was the difficulty score for swallowing the capsule, which was assessed on a visual analog scale ranging from 0 (very easy with no nausea) to 10 (very difficult or with severe nausea)	6 months
Primary	the time required to swallow the capsule	The capsule swallowing time was defined as the time between the first mouth image and the first esophageal image.	6 months
Primary	the success rate for swallowing the capsule at the first attempt	If the patient swallowed the capsule directly with a sip of water at the first attempt, it was defined as a success for swallowing the capsule at the first attempt; if the capsule entered the esophagus after several swallowing attempts or with endoscopic placement, it was defined as a failure.	6 months
Secondary	the number of images captured for Z-line and quadrants of the Z-line	Visualization of the esophagus indicated by the number of images captured for Z-line and how many quadrants of the Z-line were observed.	6 months
Secondary	Visualization score of the gastric mucosa	To objectively evaluate the complete visualization of the gastric mucosa in the 6 anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus), a 3-point grading scale was used: 1, poor (<70% of the mucosa was observed), 2, fair (70%-90% of the mucosa was observed), and 3, good (>90% of the mucosa was observed).	6 months
Secondary	Visualization of the small bowel	Visualization of the small bowel was determined by the small bowel complete examination rate.	6 months
Secondary	Difficulty score of swallowing the capsule	To evaluate the difficulty score of swallowing the capsule. After the examination, the patient was asked to complete a questionnaire. A visual analogue scale ranging from 0 (easy with no nausea) to 10 (very difficult or with sever nausea) was used to evaluate the degree of difficulty of swallowing the capsule.	1 month
Secondary	Gastrointestinal transit time	Examination-related parameters included esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), pylorus transit time (PTT), small bowel transit time (SBTT). ETT is defined as the time between the first esophageal image and the first gastric image. GTT is defined as the time between the first gastric image and the first duodenal image. GET is defined as the time for examination of gastric primary anatomic landmarks twice. PTT is defined as the time between the first pyloric image and the first duodenal image. SBTT is defined as the time between the first duodenal image and the first cecal image.	1 month
Secondary	Detection rate of lesions	The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by mini-sized MCE and normal-sized MCE.	1 month
Secondary	Safety of mini-sized MCE procedure:presence of any adverse events during mini-sized MCE procedure will be recorded	presence of any adverse events during mini-sized MCE procedure will be recorded	1 month