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that use single balloon enteroscopy to diagnose and manage lesions in small intestine, including pathology of the small intestine lesion causing GIB.. However, studies and evaluation of

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RESEARCH SUMMARY

1.Background

Gastrointestinal bleeding (Gastrointestinal bleeding) is one of the most common emergencies both in surgery and in internal medicine According to the traditional classification, gastrointestinal bleeding (GIB) is divided into two categories: upper GIB and lower GIB Today, this classification has been divided more specifically according to regions, including: GIB in the small intestine and lower GIB (bleeding in the colorectum)

Despite progress in diagnosis and treatment, especially with various new drugs being used in clinical practice, the mortality rate due to GIB is still high, ranging from 6-8% There have been many techniques applied to the diagnosis and treatment of GIB in general and in small intestinal, including single-ball endoscopy So far, in Vietnam, there are several hospitals (including Bach Mai Hospital, Military Central Hospital 108, Cho Ray Hospital ) that use single balloon enteroscopy to diagnose and manage lesions in small intestine, including pathology of the small intestine lesion causing GIB However, studies and evaluation of the effectiveness of this method in Vietnam are still limited, so we conducted this research

on the “Application of single balloon endoscopy in diagnosis and treatment of suspected

gastrointestinal bleeding in small intestine” with the two following objectives:

1 Investigate clinical features, diagnostic results, and interventions through single-balloon endoscopy

in patients with suspected gastrointestinal bleeding in the small intestine.

2 Evaluation of specification and safety of single-balloon endoscopy in patients with gastrointestinal bleeding in the small intestine.

2 The necessity

In the 60s and 70s of the last century, GIB in the small intestine was considered as a "mysterious area" because there were no means of diagnosis and intervention By the end of the 20th century, a series of diagnostic imaging methods became available, making the diagnosis of GIB causes in the small intestine more feasible However, the disadvantage of these methods was only to help diagnosis, instead of

intervention In 2001, for the first time, the double ball colonoscopy technique was introduced By 2006, Olympus company (Japan) launched a single ball colposcope These techniques have been introduced to bring high efficiency in diagnosis and endoscopic intervention (hemoclip, polypectomy ) with lesions in the small intestine Since 2010, the Department of Functional Exploration - Bach Mai Hospital has also implemented single ball colonoscopy technique to diagnose and treat GIB in the small intestine

Therefore, a full research on the efficacy of single balloon endoscopy in the diagnosis and treatment of GIB in the small intestine is essential

3 Contributions of the thesis

The dissertation has determined the diagnostic effectiveness and treatment potential through single balloon endoscopy Specifically:

- The rate of detecting lesions in the small intestine through single balloon endoscopy is: 64/89 patients (71.9%)

- Common lesions (n = 64): Small intestine ulcers: 34.4%; inflammation of the of the small intestine mucosa 23.4%; tumors: 17.2% and vascular dysplasia: 12.5%

- Common lesion location: ileum: 40.6%; jejunum: 50%; ileum + jejunum: 9.4%

- Rate of intervention through single balloon small bowel endoscopy: 90.1%

- Types of intervention: biopsy: 60.9%; clip hemostasis: 10.9%; hemostasis injection: 7.9%; coagulation

by electricity: 4.7%; polypectomy: 4.7%

At the same time, the dissertation has also raised the technical characteristics and safety of single

endoscopy in patients with suspected GIB in the small intestine

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4 The thesis layout

The thesis is presented 132 pages including: 2-page problem statement, 34-page overview, 29-page subjects and research methods, 30-page research results, 34-page discussion, 2-page conclusions and one-page recommendations

The thesis has 38 tables, 8 charts, including 164 references including 16 Vietnamese documents and 148 English documents

CHAPTER 1 DOCUMENT OVERVIEW 1.1 Small intestine anatomy and physiology

1.2 Classification, clinical, factors related to GIB in small intestine.

1.2.1 Classification of gastrointestinal bleeding

1.2.2 Clinical GIB in small intestine

1.2.3 Level and early prognostic factors for GIB in small intestine

1.3 Causes of GIB in the small intestine.

Table 1.3 Causes GIB from small intestine

Vascular lesions * Arteriovenous malformation: AVM

* Venous ectasia

* Angioplasia

* Telangiectasia

* Varices

* Dieulafoy’s lesion

* Arterial aneurysm

* Aortoenteric fistula Structural

abnormalities

* Mucosal ulcerations

* Meckel’s Diverticulum

* Radiation enteritis

* Diverticulosis

* Tuberculosis, parasite

* Endometriosis

* Crohn’s Disease Benign small

bowel tumors

* Adenoma

* Lipoma

* Neurofibroma

* Hemangioma

* Cowden Disease

* Schwannomas

* Nodular lymphoid hyperplasia Malignant small

bowel tumors * Adenocarcinoma* Lymphoma

* Leiomyosarcoma – GIST

* Carcinoid Metastatic small

bowel tumors

Lung carcinoma Breast carcinoma Renal cell carcinoma

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1.4 Methods of diagnosing GIB in the small intestine

1.4.1 Enterography with barium

1.4.2 Computerized tomography

1.4.3 Angiogram

1.4.4 Tc-99m scans attached to autologous red blood cells.

1.4.5 Modern methods on investigation of the small intestine

1.4.5.1 Capsule endoscopy

1.4.5.2 Spiral enteroscopy

1.4.5.3 Double balloon enteroscopy

1.4.6 Single balloon enteroscopy

Single balloon endoscopy has several advantages such as:

+ Giving alive images of the entire small intestine

+ Being able to do procedure and take samples when detecting lesions

+ Doable technique and does not need a lot of assistants during the procedure

+ Complications tend to be less than that of dual ball colonoscopy

The main disadvantages of single balloon enteroscopy include:

+ The duration of a colonoscopy can be long

Diagnostic and therapeutic efficacy of single ball colonoscopy:

There are 6 randomized pilot studies comparing the rate of detecting small intestine lesions between single balloon enteroscopy (SBE) and double balloon enteroscopy (DBE) The rate of detecting lesions in the small intestine of SBE ranges from: 42-64.6% The rate of detecting lesions in the small intestine of DBE ranged from 28-67.1%

Research findings show that the ability of the DBE to complete the small intestine tends to be better than the SBE Although the ability to complete small intestine enteroscopy is not as high as the one of DBE But in contrast, manipulation of doing SBE is simpler, and time is shorter via oral route than that of the DBE

Advantage of enteroscopy is that it can be therapeutic The therapeutic intervention includes hemostatic clipping, polypectomy, coagulated hemostasis, and lesion biopsy Depending on different studies, the rate of therapeutic intervention is also different The intervention rates ranged from 4.6% to 48%

There are studies presenting complications after SBE as well as DBE, which include abdominal pain, diarrhea, vomiting blood, black stools, nausea, indigestion However, the authors also believe that the rate of complications depends much on different factors, especially in terms of the endoscopist's

experience and the patient's well-being

1.4.6 Research on enteroscopy in Vietnam

CHAPTER 2 SUBJECTS AND METHODS OF RESEARCH

2.1 Subjects

89 patients with suspected GIB in the small intestine They underwent gastroscopy and colonoscopy, but

no lesions were found Patients were hospitalized at the Gastroenterology Department - Bach Mai

Hospital and Gastroenterology Department - National 108 Hospital All patients were undergone a SBE during the treatment period in hospital

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Study period: April 2010 to June 6, 2020.

2.1.1 Criteria for selecting research candidates.

- Clinical: patients have symptoms of vomiting blood and/or black stools

- The patient has had twice both gastroscopy and colonoscopy, but no lesions were found

* Criteria for selection of enteroscopy route: Patients will be selected for oral enteroscopy first if bleeding points cannot be detected through both gastroscopy and colonoscopy because the oral approach is easier, and the exploration distance is longer Patients selected for rectal-approach examination before having oral enteroscopy with undetectable lesions and when colonoscopy showed fresh blood, blood clots at the end of the ileum and cecum (Suspected bleeding in the lower segment of the small intestine)

- All patients underwent oral and / or rectal SBE

2.1.2 Exclusion criteria

- Patient is too old and weak, pregnant woman

- Patients with heart failure, respiratory failure is contraindicated for endoscopic anesthesia

- Patients with hemodynamic disorders

- Patient disagrees to participate in the study

- Patient has history of serval abdominal surgeries

2.1.2.1 Indications and contraindications for SBE

Contraindications and contraindications for SBE

- Indication:

+ Bleeding due to lesion in the small intestine

+ Occult GI bleeding suspected in the small intestine

+ Diagnosis and treatment of lesions that narrow the small intestine

+ Removal of foreign bodies in the small intestine

+ Other small bowel diseases (diarrhea, tumors, polyps )

- Contraindicated

+ Availability of acute diseases in the esophagus such as chemical burns, acute ulcers, esophageal stenosis

+ Severe heart failure

+ Myocardial infarction

+ High blood pressure, low blood pressure

+ Dilated aorta

+ Pulmonary embolism, respiratory failure

+ Colon perforation

+ Peritonitis

+ Having shock condition

+ Difficulty breathing due to any cause

+ Cardiac arrhythmia without anesthesia indication

+ Patient recently operated on the stomach, colon, pelvic area

+ Ulcerative colitis with severe bleeding

+ Patients with old age, severely debilitated condition and cannot undergo the examination

+ Uncoordinated mental patients

+ Severe blood clotting disorder

+ Pregnant condition

2.1.2.2 Contraindicated with anesthetics.

- Allergy to the anesthetics, contrast drug

- Epilepsy unstable, mentally ill, or difficult to communicate

- Pregnant women, children under 3 years old

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- Severe liver failure, kidney failure

2.2 Research Methods

2.2.1 Research Methods

Descriptive study, cross-sectional study, interventional treatment

2.2.2 Research design

Conduct research according to cross-sectional descriptive method, therapeutic intervention

- The sample size is calculated by the following formula:

Z2

1-α/2 x p x (1 - p)

n =

d2

Where: Z21-α / 2 = 1.96 (95% confidence interval)

p: is the accuracy of the solution In this study, we choose p = 0.66 We based on the study of Kim TJ et

al because the object of this study is quite similar to our study

d: is desired absolute error We choose d = 10% (0.1) and when replacing the formula, we have n = 88 + In the period from April 2010 to June 2020, there were 89 patients suitable with the selection criteria to

be included in the study

2.2.3 Study stages

2.2.4 SBE.

2.2.4.1 SBE system

+ Small bowel endoscope (Olympus SIF-Q180, Japan)

+ Splinting tube

+ Balloon Control Unit (OBCU)

2.2.4.2 Other accessory equipment and tools

2.2.4.3 Single balloon enteroscopy

a) Prepare the patient for the procedure

b) Technical technique

c) Steps to conduct a single balloon colonoscopy

* Perform anesthesia

* Enteroscopy of the small intestine by oral route

+ Insert the splint into the endoscope and push up near the middle of the scope

+ Put the endoscope through the esophagus - stomach, to the duodenum and try to push the scope into the deep of the jejunum

+ When the scope is fully in place, push the splint to the insider, near the curved end of the scope, then stop To be careful, check the end of the brace on the bright display

+ Then, proceed to inflate the balloon to fix the small intestine, then pull the splint and the scope out When not pulling anymore, continue to push the filament deep inside This process was repeated over and over, until the most profound lesions are found, and the scope reaches the deepest area in the small intestine

* Enteroscopy with the rectal approach

+ Step 1 (at Sigma colon): Pump up the balloon, pull out both the scope and the splint to shorten the Sigma colon

+ Step 2 Aspiration in the balloon to deflate the balloon and continue to push the colonoscope to the splenic colon

+ Step 3 In the colon the spleen angle inflates the balloon

+ Step 4 and 5 Push the machine across the transverse colon, down to the ascending colon

+ Step 6 inflate the ball, pull out the scope and the tube brace

+ Step 7 Push the scope through the valve Bauhin into the ileum In the ileum, the steps for enteroscopy are the same as for the technique via oral route

2.2.4.4 Techniques for interventions with SBE

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2.2.5 Research indicators

2.2.5.1 Clinical investigation, diagnosis and endoscopic intervention results

a) General characteristics of the patient

b) Clinical information prior to admission

+ Reason for admission

+ Characteristics of vomit: color, number of times, quantity

+ Stool features: color, number of times, quantity

+ Evaluate the GIB status

c) Diagnosis through SBE

- The rate of lesion detection on SBE

- Characteristics of endoscopic lesions: location (ileum, jejunum, ileum + jejunum), types of lesions (vascular dysplasia, tumor of the small intestine, ulcer of the small intestine, inflammation of the small intestine, Meckel diverticulosis )

d) Intervention through SBE

- Rate of biopsy through SBE

- Histopathology

- The rate of treatment through SBE

- Endoscopic treatment techniques: polypectomy, hemostasis injection, hemostatic clip, coagulation

2.2.5.2 Specification and safety of single-ball colonoscopy

a) Technical specification of single balloon enteroscopy

- Average time of performance

- Depths of small bowel insertion (m):

- Assessment of lesion: number, size, location, morphology, bleeding status (bleeding, no longer

bleeding )

b) Single balloon enteroscopy

+ Images of normal small intestine endoscopy: the small intestinal mucosa villi has a finger-shaped protrusion in the lumen of the intestine, 0.5-1mm high, the highest in the jejunum and shorter in the ileum The blood vessels observed were clearer in the ileum than in other intestinal segments

+ Hypertrophy of lymphocysts: is a condition where there are 10 lymphocysts protruding from the surface

of the mucosa, overgrown lymphoid follicles are white, yellowish, soft and have diameter up to 2 mm Small bowel disease caused by NSAID: manifested in an ulcerative form often with bleeding, perforation, narrowing or obstruction of the intestine Lesions on endoscopic images vary from villi degeneration and erosive erosions to major lesions such as perforation and septum formation These lesions are numerous and have thin walls, concentric mucosa-like septum, narrowing the intestinal lumen

+ Angiodysplasia

+ Small bowel tumor: Carcinoid tumors usually locate under the mucosa, prominent in the ileum, slightly increased in size and often found by chance

+ Bleeding due to Meckel diverticula ulcers

+ GIST: The most found in jejunum, then the ileum, and the duodenum GIST usually develops from the muscular layer, as submucosal mass, but sometimes as sub-serosa mass

+ Blood tumor: is a neoplastic lesion caused by the vascular production of blood vessels, which is usually benign

+ Dieulafoy ulcer: is a bleeding artery damage but no ulcer

+ Aphthous ulcer: is a small, shallow, concave lesion with loss of villi These lesions are considered early stage of Crohn's disease Endoscopic image with erosions or small ulcers

+ Inflammatory fibroid polyp: is a non-malignant hyperplasia of the gastrointestinal tract Lesions have the form of a submucosal tumor that is not sessile or sessile

+ Submucosal tumor: is a tumor that develops from the lower epithelial layer protruding the mucosa into the lumen of the intestine

c) Follow-up for complications

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Complications during anesthesia: slow pulse, low blood pressure, respiratory failure, hiccups, increased secretion in the mouth

+ Complications during endoscopy: bleeding, perforation, blood pressure drop

+ Complications after enteroscopy: abdominal distension, abdominal pain, fever, acute pancreatitis, infection, perforation, respiratory inflammation

2.2.6 Histopathological standards

2.3 Data processing

The collected data are processed according to the statistical algorithm used in biomedical program with SPSS 20.0 software

2.4 Research ethics

CHAPTER 3 RESULTS 3.1 Characteristics of the research population

3.1.1 Age

The most common age is 20 - 59, accounting for 60.7%; 60 and over accounting for 34.8%, patients under 20 only account for 4.5% The average age of women is: 49.7 ± 18.0, in men: 49.07 ± 20.23 Average age in both gender: 49.3 ± 19.33

3.1.2 Gender characteristics

The number of male patients accounts for: 62.9% The ratio of male/female = 1.7

3.1.4 History of gastrointestinal bleeding

64% of patients had a history of GIB prior to admission, of which mainly happened one time (59.6%)

3.1.5 The reason for admission

The main reason that patients admitted to the hospital is black stools (62.9%) Other symptoms are more frequent

3.1.6 Initial diagnosis

3.1.7 Signs and symptoms

Table 3.5 Signs and symptoms upon admission

Comments: the most common signs are fatigue (74.2%), dazzled (68.5%), dizziness (67.45); the most common physical symptoms are blood stools (85.4%), pale skin (70.8%)

3.1.9 Classification of clinical blood loss level

Severe, medium and mild GIB level accounts for 11.3%, 39.3% and 49.4%, respectively

3.2 Endoscopic findings

3.2.1 Lesion detection rate on SBE

64/89 patients (71.9%) had lesions on the enteroscopy

3.2.2 Images of lesions on SBE

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Table 3.13 Endoscopic images of lesions detected on enteroscopy

Bleeding ulcer on Merkel’s

Comments: Common lesions include ulcers in the small intestine (34.4%), inflammation of the small intestine mucosa (23.4%), tumors (17.2%) and angiodysplasia (12.5%)

3.2.3 Proportion of lesions found on enteroscopy routes.

Table 3.14.The rate of lesions detected by enteroscope routes

Comments: 51.6% of lesions are detected through the combined endoscopy, 37.5% is via oral and 10.9%

is via anal approach

Table 3.15 The rate lesions detected by the length of small intestine

Length of small

intestine examined (m)

0,33

2 - < 3 7

28,0

1 3

20,3 20

22,5

≥ 3

13 52,0 40 62,6 53 59,6

0

6 4

100,0 89 100,0

Average 2,61 ± 0,93 3,12 ± 1,35 2,97 ± 1,26 0,09 Comment: The detection rate of small intestinal lesions tends to increase with the length of the intestine examined

3.2.4 Relationship between endoscopic lesions and gender

Table 3.16 Relationship between causes of GIB and gender

Gender Causes of GB

Bleeding ulcer on Merkel’s

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Jejunum/ileum’s ulcers 7 30,4 15 36,6 Jejunum/ileum’s polyps 2 8,7 1 2,4

Jejunum/ileum’s mucositis 6 26,2 9 22,0

Comments: The rate of inflammation lesion on small intestine mucosa and small bowel tumors tends to

be seen more in women; In contrast, vascular dysplasia, intestinal ulcers tend to be more common in men

3.3 The lesion's location on the SBE findings and its relationship

3.3.1 Distribution of lesion location on the SBE

Table 3.19 Location of lesions on the SBE findings

Image of lesions on enteroscopy is most common in the jejunum (50.0%)

3.3.2 The relationship between the lesion location and the manifestation of blood vomiting

3.3.5 Relation of lesion location with lesion image

Table 3.23 Relationship of lesion location and the endoscopic images

Lesion location Causes of GB

jejunum

Total

Bleeding ulcer on

Merkel’s diverticula

1 (50,0) 1 (50,0) 0 2 (100,0)

Jejunum/ileum’s ulcers 10 (45,5) 7 (31,8) 5 (22,7) 22

(100,0)

Jejunum/ileum’s polyps 3 (100,0) 0 0 3 (100,0)

Jejunum/ileum’s

mucositis

4 (26,7) 10 (66,7) 1 (6,6) 15

(100,0)

(100,0)

Comments: The rate of vascular dysplasia, small bowel ulcers, polyps had a higher prevalence in the ileum, while the rate of small bowel tumors, submucosa tumors, inflammation of the small intestinal mucosa was more common in the jejunum (p = 0.14)

3.4 Histopathology and its association

3.4.1 Histopathology test rate

There are 42/89 patients (47.2%) undergoing histopathological tests when performing enteroscopy

3.4.2 Histopathology findings

Table 3.24 Histopathological results

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GIST 2/42 4,8 Small intestine mucositis 22/42 52,4 Gastrointestinal

Chronic duodenum

Comments: Common injury includes inflammation of small intestinal mucosa (52.4%), chronic ulcer (23.8%)

3.4.3 Relationship between histological result and some clinical features

Table 3.29 Relationship between histopathological results and causes of GB

HR

Causes of GB

Chronic -ulcers

Hyper-plastic polyp

sitis

Others

Comment: In 3 cases of polyps, histological result is all polyp (100%); 17 cases of small bowel ulcers, Histological results: chronic ulcer (n = 10), inflammation of the small intestine mucosa (n = 5); 14 cases

of mucosal congestive inflammation, histological result: inflammation of the small intestinal mucosa (n = 12)

Table 3.30 Relationship between histopathological results and lesion locations

HR

Location of lesions

Chronic -ulcers

Hyper-plastic polyp

GIST mucositis Others

Ileum 4 (40,0) 3 (100,0) 0 (0,0) 9 (40,9) 1 (20,0)

Jejunum 2 (20,0) 0 (0,0) 2 (100,0) 11 (50,0) 4 (80,0)

Jejunum + ileum 4 (40,0) 0 (0,0) 0 (0,0) 1 (9,1) 0 (0,0)

Comment: Inflammation of the small intestinal mucosa (chronic, progressive) in the jejunum tends to be higher in the ileum, while chronic ulceration tends to be higher in the ileum than in the jejunum (p = 0.04)

3.5 Therapeutic intervention with SBE

3.5.1 The rate of therapeutic intervention with SBE

There are 59/64 patients (90.1%) among the SBE candidates

3.5.2 Types of intervention with SBE

Table 3.31 SBE interventional procedures

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