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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: Investigate clinical features, diagnostic results, and interventions through single-balloon endoscopy in patients with suspected gastrointestinal bleeding in the small intestine Evaluation of specification and safety of single-balloon endoscopy in patients with gastrointestinal bleeding in the small intestine 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 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 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 onepage recommendations The thesis has 38 tables, charts, including 164 references including 16 Vietnamese documents and 148 English documents CHAPTER 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 Causes Lesions Vascular lesions * Arteriovenous malformation: AVM * Venous ectasia * Angioplasia * Telangiectasia * Varices * Dieulafoy’s lesion * Arterial aneurysm * Aortoenteric fistula Structural * Mucosal ulcerations abnormalities * Meckel’s Diverticulum * Radiation enteritis * Diverticulosis * Tuberculosis, parasite * Endometriosis * Crohn’s Disease Benign small * Adenoma bowel tumors * Lipoma * Neurofibroma * Hemangioma * Cowden Disease * Schwannomas * Nodular lymphoid hyperplasia Malignant small * Adenocarcinoma bowel tumors * Lymphoma * Leiomyosarcoma – GIST * Carcinoid Metastatic small Lung carcinoma bowel tumors Breast carcinoma Renal cell carcinoma 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 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 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 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 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 years old - 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: Z21-α/2 x p x (1 - p) n= d2 Where: Z21-α / = 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 (at Sigma colon): Pump up the balloon, pull out both the scope and the splint to shorten the Sigma colon + Step Aspiration in the balloon to deflate the balloon and continue to push the colonoscope to the splenic colon + Step In the colon the spleen angle inflates the balloon + Step and Push the machine across the transverse colon, down to the ascending colon + Step inflate the ball, pull out the scope and the tube brace + Step 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 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 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 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 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 Symptoms N (n= 89) Abdominal pain 11/89 Fatigue 66/89 Orthostatic hypotension 61/89 Dizziness 60/89 Unconsciousness 42/89 Hematemesis 13/89 Hematochezia/Melena 57/89 Pale skin color 63/89 % 12,3 74,2 68,5 67,4 47,2 14,6 64,0 70,8 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 Table 3.13 Endoscopic images of lesions detected on enteroscopy Causes N (n= 64) % Angiodysplasia 12,5 Tumor 11 17,2 Bleeding ulcer on Merkel’s 3,1 diverticula Dieulafoy’s lesions 1,6 Jejunum/ileum’s ulcers 22 34,4 Jejunum/ileum’s polyps 4,7 Subepithelial tumors 3,1 Jejunum/ileum’s mucositis 15 23,4 Total 64 100,0 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 Route n % p Anterograde 24/64 37,5 Retrograde 7/64 10,9 0,29 Dual route 33/64 51,6 Total 64/64 100,0 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 Non Yes Total p intestine examined (m) n % n % n %

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