The application of magnetically controlled capsule endoscopy in gastrointestinal bleeding patients

doi:10.21203/rs.3.rs-2986570/v1

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The application of magnetically controlled capsule endoscopy in gastrointestinal bleeding patients

https://doi.org/10.21203/rs.3.rs-2986570/v1

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Background

Magnetically controlled capsule endoscopy (MCCE) could simultaneously complete the observation of gastric and small bowel mucosa in one examination. It could not support therapeutic procedure. We aimed to evaluate the application of magnetically-control capsule endoscopy in gastrointestinal bleeding patients.

Methods

We reviewed the data of patients that finished MCCE in West China hospital, Sichuan University between 2021 January to 2021 December. In total of 123 patients, 50 complained of gastrointestinal bleeding symptoms were included. All patients’ data including gastrointestinal bleeding symptoms, comorbidities, drug history and laboratory test results were collected and analyzed.

Results

In all the patients, 92% patients had overt gastrointestinal bleeding symptoms, including melena (50%) and hematochezia (42%). The average hemoglobin concentration was 82.44 ± 17.33 g/L, and the median Glasgow-Blatchford score (GBS) was 8. Before MCCE examination, 28% patients had not received any endoscopic screening due to severe comorbidities, and the remaining 72% was considered as obscure gastrointestinal bleeding. MCCE detected gastrointestinal lesions in 96% patients, in which, 68% patients showed active bleeding lesions or recent hemorrhage stigmata during examination, including upper gastrointestinal lesions in 4 cases, small bowel lesions in 30 cases and colonic lesion in 1 case. In the other cases without bleeding signs, MCCE detected small bowel lesions in 11 cases, upper gastrointestinal lesions in 2 cases and colonic lesion in 1 case. All the patients finished both gastric and small bowel screening in one time. There were no side effects in all the patients during or after the MCCE examination, including emergency endoscopy intervention.

Conclusions

MCCE is available and safe in gastrointestinal bleeding patients with symptoms of melena, hematochezia, fecal occult blood positive and iron deficiency anemia of unknown origin.

Capsule endoscopy

Gastrointestinal bleeding

Indication

Gastrointestinal bleeding is a common medical condition, and ranges in severity from self-limiting to fatal. Traditional electronic esophagogastroduodenoscopy (EGD) and colonoscopy are recommended to diagnose and treat the bleeding lesions. However, therapeutic endoscopy is not always necessary. Proton pump inhibitors could effectively decrease the Forrest classification of peptic ulcer and reduce the need for endoscopic hemostasis [1], and the endoscopy intervention in lower gastrointestinal bleeding was 2.1–4.6% [2, 3]. It is reported that up to 35% hospitalized patients did not receive the endoscopic hemostasis with an undefined bleeding location [4]. Moreover, bleeding could result from multiple lesions, as aspirin could damage both the gastro and small bowel. Patients might need more than once endoscopy examination, including EGD and capsule endoscopy.

Magnetically controlled capsule endoscopy (MCCE) is a novel endoscopy tool that could exam gastro and small bowel in one time. It provides comparable accuracy to the standard EGD in the gastric lesion detection and also elevate the completion ratio of small bowel examination [5–7]. However, MCCE could only be used as a diagnostics tool, and could not provide therapeutic processing. In this study, we aimed to evaluate whether MCCE could be safely used in the gastrointestinal bleeding patients and its diagnostic efficiency.

Patients

This was a retrospective study that conducted in West China Hospital, Sichuan University. We collected the patients’ data that satisfy the following criteria: (1) taken MCCG examination because of gastrointestinal bleeding symptoms, including melena, hematochezia, positive fecal occult blood test or iron deficiency anemia of unknown origin; (2) finished the MCCG examination during 2021 January to December. This study was approved by the Medical Ethics Committee of West China Hospital, Sichuan University, and informed consent was remitted.

The MCCE procedure

The MCCE system (Ankon Technologies, Shanghai, China) consists of an endoscopic capsule, a waistcoat (data receiver and recorder), a detector, and a guidance magnet robot and a computer workstation. All patients took 4 L polyethylene glycol the night before MCCE for bowel preparation, and before the examination ingest 20,000 IU of Pronase granules with 1 g of NaHCO3, 6ml of simethicone emulsion and 200 ml of water and walked around for 30 minutes. Then, they ingested 500–800 ml of water before capsule ingestion. Next, patients laid supine on the bed and swallowed the capsule. When the capsule got into the esophagus, the patient needed to do swallowing action without water in order to have a clear view of esophagus. After the capsule reached stomach, the examination procedure would be conduct according to the instruction [8].Generally, doctor controlled the capsule movement through magnetic power, after finishing the gastric examination, capsule would be controlled to pass through the pylorus.

Statistical analysis

Continuous variables were expressed as mean ± standard deviation (SD), and analyzed using Student’s t tests or Mann-Whitney Test. A two-sided P value < 0.05 was considered statistically significant.

Patients’ characteristics

A total of 123 patients’ data were reviewed, 50 took magnetically-control capsule endoscopy examination (MCCE) because of gastrointestinal bleeding symptoms, including melena, hematochezia, fecal occult blood positive or iron deficiency anemia of unknown origin. There was no complain of hematemesis. In all patients, the average age was 60.50 ± 17.55 years, and 56% were male. 92% of them had overt bleeding symptoms, including 25 melena and 21 hematochezia. The average hemoglobin concentration was 82.44 ± 17.33 g/L, and the median Glasgow-Blatchford score was 8 (range from 0 to 15). 34% patients had a drug history of gastrointestinal side effects, including nonsteroidal anti-inflammatory drugs, antiplatelets, anticoagulation, glucocorticoids and metformin. (Table 1)

Table 1

Patients’ Characteristics
Parameters	Number	Percentage
Sex
male	28	56%
female	22	44%
Age
> 60	30	60%
≦ 60	20	40%
Bleeding symptoms
overt	46	92%
melena	25	50%
hematochezia	21	42%
obscure	4	8%
anemia of unknown origin	3	6%
FOB+	1	2%
Drug history
Non-aspirin NSAIDs	2	4%
Antiplatelets	8	16%
Anticoagulation	5	10%
Glucocorticoids	2	4%
Metformin	2	4%
None	33	66%
Comorbidities
IHD	38	76%
Hypertension	28	56%
Diabetes	44	88%
CKD	43	86%
Liver Disease	42	84%
Endoscopy history
yes	36	72%
No	14	28%
FOB+: positive fecal occult blood test; NSAIDs: non-steroidal anti-inflammatory drugs; IHD: ischemic heart disease; CKD: chronic kidney disease.

Before the MCCE, 72% (36) patients had finished both the EGD and colonoscopy examinations, and no findings of bleeding lesions. The remaining 28% patients had not because of severe comorbidities, and could not tolerate the anesthesia and traditional endoscopy. In all the patients, the most common comorbidities were diabetes (88%), chronic kidney diseases (86%) and liver diseases (84%). Also, 76% patients had a history of ischemic heart disease, and 56% had hypertension. The Charlson comorbidity index (CCI) was significantly lower in the patients who had taken traditional endoscopy before than the ones that taken MCCE as the initial examination (3 vs 6, Mann-Whitney Test p = 0.002). But the GBS score was similar between the two group patients (7.69 vs 9.50, Mann-Whitney test p = 0.10).

Magnetically-control capsule endoscopy examination (MCCE) findings

All of the 50 patients finished both of the gastro and small bowel examination without exacerbation of bleeding. There were 48 (96%) patients revealed lesions in MCCE examination, including 6 upper gastrointestinal lesions, 41 small bowel lesions and 2 colonic lesions (Table 2). No positive findings in the other two patients.

Table 2

MCCE findings
Parameters	location	Lesion	Case Number
Active Bleeding/stigmata of recent hemorrhage
Yes			34 ^a
	Gastro/duodenum		4 ^a
		Peptic ulcer	2
		Portal hypertensive gastropathy	1
		Gastric antral vascular ectasia	1^b
	Small bowel		30 ^a
		Vascular malformation	25
		Tumor	2^c
		Erosion	2^d
		Small bowel vascular ectasia	1^b
	Colon	Vascular malformation	1
No			16
	Gastro/duodenum		2
		Peptic ulcer	1
		Portal hypertensive gastropathy	1
	Small bowel		11
		Vascular malformation	7
		Erosion	4^e
	Colon	Vascular malformation	1
	No finding	-	2
^a: One patient showed both the gastric and small bowel bleeding
^b: This patient had lesions in both of gastro and small bowel
^c: One was stromal tumor, the other one was unknown because patient did take any biopsy or operation.
^d: One was diagnosed as aspirin associated enteropathy, the other was considered as the uremia related mucosal injuries.
^e: One patient was final diagnosed as Henoch–Schönlein purpura.

During the examination of MCCE, active bleedings or stigmata of recent hemorrhage were found in 34 (68%) patients. It was revealed that 29 (58%) patients had bleeding lesions in small bowel, 3 (6%) in upper gastrointestinal tract (gastro or duodenum), 1 (2%) in colon, and 1 (2%) in both the gastro and small bowel. For small bowel, vascular malformation was the most common lesions (25, 86%) (Table 2). Small bowel tumors were found in 2 cases, one received operation and was diagnosed as stromal tumor, the other one did not take further treatments because of severe comorbidities, which include liver cirrhosis and coronary heart disease. The interesting thing was that in one patient with small bowel tumor, duodenal ulcer was also found without recent hemorrhage stigmata (Fig. 1). Two patients showed multiple erosions in small bowel, and one of them was finally diagnosed as aspirin associated enteropathy with more than 3 years drug history (Fig. 2), the other one was considered to develop multiple erosions because of uremia. Three patients were diagnosed as upper gastrointestinal bleeding, and peptic ulcers were found in two, the other one was portal hypertensive gastropathy. The patient with colonic bleeding finished colonoscopy and showed vascular malformation in colon. One patient revealed both the gastric antral vascular ectasia and small bowel vascular ectasia, and active bleeding was found in multiple parts of small bowel as well as the gastro during MCCE (Fig. 3).

The other 16 patients showed no bleeding signs during MCCE examination. In these patients, there were no positive findings in 2 complained of melena. One of them had taken traditional electronic endoscopy before, and the remaining one had not. Meanwhile, MCCE revealed small bowel lesions in 11 patients, which included 7 vascular malformation and 4 erosion cases. In one of the erosion cases, the patient was finally diagnosed with Henoch–Schönlein purpura, and the other three patients had a drug history of aspirin. There were 2 cases found with gastric lesions, including one portal hypertensive gastropathy and one peptic ulcer. The MCCE also revealed colonic vascular malformation in one case, which was confirmed by colonoscopy.

There were no patients got emergence endoscopy treatment after or during MCCE examination. 5 of them were outpatients, and the other 45 inpatients were discharged with successful hemostasis.

In this study, we found that MCCE could be safely and efficiently used in gastrointestinal bleeding patients, that presented with melena, hematochezia, positive fecal occult blood test or iron deficiency anemia of unknown origin.

MCCE has a significant advantage over the tradition EGD and capsule endoscopy, that allows for noninvasively gastric and small bowel examination in one time. It was reported that MCCE could effectively detect the gastric lesions as the traditional EGD [9]. Moreover, MCCE detects lesions under water could clearly reveal tiny bleedings, and also observes the cardia in natural status, which would not be sheltered by the electronic endoscopy body (video 1). On the other hand, the inverted observation of duodenum is usually difficulty in EGD, and traditional capsule usually lose the view of duodenum. However, MCCE with a capsule body that controlled with magnetic power, could observe the duodenum more easily (video 2). Also, it could be controlled to pass through the pylorus, its small bowel completion rate was significantly higher than the traditional capsules [5]. In this study, we revealed 6 upper gastrointestinal lesions and 2 colonic lesions with MCCE. The diagnostic yield of MCCE in our study is higher (48/50, 96%) than the reported 47–86% of traditional capsule endoscope [10].

It is reported 5% patients who had finished the EGD and colonoscopy could not reveal the bleeding lesions [11]. In these patients, guideline recommended to repeat the standard endoscopy examination, and up to 25% patient would discover the bleeding origins, and the remaining ones still need further small bowel examination [12]. In this study, patients that considered as obscure gastrointestinal bleeding finished MCCE without need for further traditional EGD or capsule endoscopy. Therefore, we considered that MCCE might be a good choice for the gastrointestinal bleeding patients with negative findings in the traditional endoscopy.

There were 28% patients did not take any traditional endoscopy before the MCCE. They had a higher CCI, which meant a higher risk in traditional endoscopy procedure. However, MCCE could be safely used in the patients with severer comorbidities, as ischemic heart disease and chronic obstructive pulmonary disease [13].

Drug associated gastrointestinal damages increased according to the spread use of antiplatelets and other non-steroidal anti-inflammatory drugs. They could cause multiple lesions in gastro and small bowel [14]. We also found in this study that aspirin caused erosion lesions were multiple. Therefore, for patients suspected of drug induced bleeding, MCCE might be a better choice to finish both the gastro and small bowel examination.

This is a cross-sectional study, patients’ data were retrospectively collected, we did not have enough data to analysis the timing of MCCE in the diagnostic efficiency. But all the inpatients finished the examination in the first 7 days of hospitalization. Also, there were no enough data to evaluate the bleeding frequency, or volume. We could not point out which kind of patients would be the proper candidate of taking MCCE as the initial examination. However, for patients without definite findings in EGD and colonoscopy, and suspectable of small bowel bleeding, MCCE would be a proper choice. It is need to be noted that there were no data about hematemesis, and we do not consider that MCCE could be safely used in them. As such patients had a high need for therapeutic endoscopy, and most of them had lesions in upper gastrointestinal tract, which could be easily diagnosed with traditional EGD. Also, hematemesis would result in a bad gastric view and disturb the examination.

In summary, we consider that MCCE would be a feasible diagnostic method for gastrointestinal bleeding patients, especially for those with negative findings in initial endoscopic evaluation. And for these with severe comorbidities, if the need for endoscopic therapy is low, MCCE would be a substituted choice.

Our experience of MCCE indication for gastrointestinal bleeding patients:

1、 Obscure gastrointestinal bleeding

2、 Patients with severe comorbidities and low need for therapeutic endoscopy, as infrequent melena, which should be judged by the clinicians

3、 Suspected of drug induced gastrointestinal bleeding

MCCE: Magnetically controlled capsule endoscopy; EGD: esophagogastroduodenoscopy; CCI: Charlson comorbidity index; GBS: Glasgow-Blatchford score; SD: standard deviation.

Ethics approval and consent to participate: This study was approved by the Medical Ethics Committee of West China Hospital, Sichuan University, and informed consent was remitted.

Consent for publication: Not applicable.

Availability of data and materials: The datasets used during the current study are available from the corresponding author on reasonable request.

Competing interest: The authors declare that they have no competing interests.

Funding: This study was supported by the major technology application and demonstration project 2021-YF09-00050-SN, Chengdu Science and Technology Bureau；1·3·5 Project for Disciplines of Excellence–Clinical Research Incubation Project 2020HXFH039 & 2020HXFH054, West China Hospital, Sichuan University.

Author’s contributions: Xue Xiao drafted the manuscript; Yu Zeng provided magnetically capsule endoscopy data; Ming Shen and Xiaocun Xing helped to collect the patient data; Jinlin Yang supervised the study.

Acknowledgements: None

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No competing interests reported.

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The application of magnetically controlled capsule endoscopy in gastrointestinal bleeding patients

Status:

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Abstract

Background

Methods

Results

Conclusions

Figures

Introduction:

Patients and methods:

Statistical analysis

Results:

Discussion:

Our experience of MCCE indication for gastrointestinal bleeding patients:

Abbreviations:

Declarations:

References:

Additional Declarations

Supplementary Files

Status:

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