--- --- KHAI NGUYEN DAO RESEARCH OF THE EFICIENCY OF ENDOSCOPIC HEMOCLIP OR HEMOCLIP COMBINED WITH INJECTION OF ADRENALIN 1/10000 IN PATIENTS WITH PEPTIC ULCER BLEEDING Specialit
Trang 1- -
KHAI NGUYEN DAO
RESEARCH OF THE EFICIENCY OF ENDOSCOPIC
HEMOCLIP OR HEMOCLIP COMBINED WITH
INJECTION OF ADRENALIN 1/10000
IN PATIENTS WITH PEPTIC ULCER BLEEDING
Speciality: Gastroe nte rology code: 62.72.01.43
SUMMARY OF MEDICAL DOCTORAL DISSERTATION
HA NOI-2020
Trang 2Scientific supervisors
1 Assoc Prof.Dr Khien Van Vu
2 Assoc Prof.Dr Thu Ho Thi Pham
Day Month Year
The dissertation could be found in:
1 Natio nal Library of Vietnam
2 108 clinical medical and pharmaceutical sciences institute
Trang 3BACKGROUND
In Vietnam, gastrointestinal bleeding (GB) is a common complication in both internal medicine and surgery Upper gastrointestinal bleeding accounts for about 70-80% of the total bleeding in the gastrointestinal tract The frequency of IDI ranged from 36 / 100,000 to 172 / 100,000 people
Endoscopic CMTH treatment has so far been classified into three main technical groups: mechanical therapy, ablation therapy, and injection therapy
Endoscopic clip clamping is a mechanical treatment that has been widely used since the 1990s, with a hemostatic effect of over 95% and a high safety In addition, the injection of hemostatic injection with adrenalin (epinephrine) 1 / 10,000 is also used in clinical practice, due to its good hemostatic effect, safer than other solutions (absolute alcohol, polidocanol )
In our country in recent years, clip techniques and adrenaline1/10,000 injection of hemostasis in endoscopy to treat gastrointestinal bleeding have been mentioned through studies The majority of authors used clips alone or injected adrenaline 1/10,000 alone No author has studied a systematic and large scale on the effectiveness of comparison between clip alone and clip combined adrenalin 1/10,000 injection for treating gastrointestinal bleeding due
to peptic ulcer Therefore, we conduct research on this topic with the following two objectives:
1 Evaluation of hemostatic results with simple clip clamps and clip clips combined with 1 / 10,000 adrenalin injection for the treatment of gastroduodenal ulcer bleeding
2 Comment on the specification, safety and a number of factors related to the outcome of treatment
Trang 4Chapter 1 OVERVIEW 1.1 ADRENALIN INJECTION METHOD
1.1.1 Inje ction technique and dosage :
+ Injection technique: using 4 corners of needle around the bleeding site, with the distance from the edge of the ulcer or bleeding place is 3-4 mm, the volume of each injection depends on the experience of the Endoscopic Doctor , injected into the lining until swollen and slightly changed color
+ Dose: The volume of injection solution depends very much
on the size of ulcer causing GI bleeding The dosage can be 0.5-1ml,
or can be used from 20 ml, 30 ml, even up to 45 ml
1.1.2 The he mostatic e ffect of he mostatic inje ction the rapy
with adre nallin
Until now, adrenalin is still a hemostatic solution that is used extensively by endoscopic therapist because of easy using and low cost Today, adrenalin 1/10000 injection is combined with other methods (hemoclips, electrocoagulation ) in the treatment of severe bleeding, when it is not possible to intervene deeply or difficult to intervene (posterior wall duodenal ulcer) Adrenalin injecting around the blood vessels is flowing may stop or reduce bleeding, which allow to reveal the bottom of the ulcer and vascular position, and create conditions for physicians to use combination therapy such as endoscopic hemostatic clips
Trang 51.5 HEMOCLIP METHOD
1.5.1 History and technical principles
The hemoclips technique was first used in 1975 by Hayashi
T et al in Japan for patients with gastrointestinal bleeding causing peptic ulcer Since then, this technique has been used in many countries around the world and brought good effectiveness in hemostasis and reducing the rate of patients having to surgery This technique is also used to hemostasis in surgery, for patients who undergo radiotherapy with bleeding complications, or tissue markers, clamps to close small holes related to submucosal dissection
The principle of clips method is based on the mechanism of using metal clips to clamp blood vessels or tissues to pinch blood vessels, which can stop bleeding, but do not cause inflammation or tissue damage such as fiber injection or heat It is usually indicated for acute bleeding ulcer or damage such as Mallory-Weiss, Dieulafoy when the lesion is small, soft
1.5.2 Effe ctive he mostasis of clips with e ndoscopic
There are many randomized studies about hemostatic effects
of hemoclip or hemoclip combined with other treatments such as injection (adrenalin injection, polidocanol, absolute alcohol, isotonic salt ), heat (photo-frezee, electrodynamics, heat frezee )
At the beginning of the birth of this hemoclip technique, there were some studies using hemoclip to evaluate the effectiveness
of hemostasis in patients with peptic ulcer
To learn about the hemostatic effect of clips, there have been
a number of studies comparing the hemostatic effect of clips and other methods Table 1.12 presents the combined therapeutic effect
Trang 6compared to momotherapy of patients with peptic ulcer and gastrointestinal bleeding
Table 1.12 Effe ctive he mostasis of clips with othe r method
asis (%)
Recurrent gastrointes tinal bleeding (%)
Op eration (%)
Fatal (%)
Trang 7Chapter 2 OBJECTIVES AND RESEARCH METHODS
2.1 RESEARCH SUBJECTS
We studied 150 patients with peptic ulcer bleeding caused
by ulcers were gone to emergency department , treated at the Internal Medicine Department of the 108 Central Military Hospital from January 2013 to March 2017 The patient was divided into 2 random groups:
+ Group I: hemoclip (n = 75)
+ Group II: hemoclip + adrenalin(1/10000) injection (n = 75)
2.1.1 Inclusion crite ria
Patients included in the study include the following criteria: + Symptomactic patients of peptic ulcer bleeding include vomiting of blood and / or black stools
+ Endoscopic images of lesions has hemostasis indication based on Forrest's classification Endoscopic therapeutic interventions were performed for Forrest IA patients to Forrest IIB
2.1.2 Exclusion crite ria
- Patients with GI bleeding due to portal hypertension
- Patients with CI bleeding complications of stomach cancer
- Patients with contraindications for gastroduodenoscopy
- Patients do not agree to participate in the study
- Patients with coagulopathy
- Aneurysms lesions, Mallory-Weiss syndrome
2.2 RESEARCH METHODS
2.2.1 Study des ign
- Research method: is a method of prospective, descriptive monitoring, vertical monitoring, randomized grouping, conducting intervention, and comparing treatment results of 2 groups
Trang 8- Sample size: Choose convenient 150 random pateints from January 2013 to March 2017 was divided into 2 groupss In group I, there were 75 patients patients received hemoclip , group II had 75 patients treated with hemocip combined with adrenalin(1/10000) injection
2.2.2 The technique of e ndoscopy he mostasis by clip
+ Step 1: Reveal ulcers
As soon as the ulcer is detected, it is necessary to assess the location, condition of the ulcer, bleeding level immediate ly and bring the scanner to the most favorable position to stop bleeding
Pump , c lean the ulcer, if blood c lot remains on the ulcer, clots must
be removed ,firstly, wash with strong pressure, if blood clot does not turn out, tools used to take out
+ Step 2: Insert the device that has inserted the clip through
the biopsy channel into the lesion position
+ Step 3: Pull out the handle to open the clip If les ion of
the stomach, the clip will be opened more convenient However, in order to increase the convenience of opening the clip, the person performing the procedure must perform the endoscopy in accordance with the regulations (do not twist the machine, cross-bend .) If lesson of the duodenum, it is necessary to expose the surrounding lesions, so that the clip can be opened smoothly
+ Step 4: Principle of clip : c lamp directly into blood vessels
at the ulcer causing bleeding Clips are paired perpendicular to the blood vessels The main physician has just pushed the clip into the clamping position, while sucking the vapor to pull the damage into the clip when the correct position has been determined, the secondary physician coordinates losely with the main physician to clam the clip In case the blood vessel is still flowing, it should be clamped above and below the position of the blood vessel that is
Trang 9following This technique is applicable to all ulcers causing GI bleeding Depending on the size of the ulcer, it can be clamped by 1-
10 clips Results are achieved when the blood flow from the ulcer is not visible
+ Ulcer causing bleeding is c lassificated in Forrest IIB : In case old clot is easy to turn out, proceed to clamp clip immediately In the case new clots is hard to cling, use pliers or snares to remove the
clot, after taking the clot while combining the washing and clamping
clips Need to monitor closely hemodynamics (pulse, blood pressure, oxygen pressure ) during the procedure
+ In case blood continues to flow, stop bleeding If unsuccessful, blood continues to flow, consultation should be switched to other methodic treatment (vascular intervention or surgery)
2.2.3 He mostatic technique with adre nalin inje ction
+ Pre pare injection solution:
- Adrenalin( 1mg / 1ml) tube
- Physiological saline (Nacl 0.9%)
- Use 10ml syringe, take 1ml of adrenaline solution, then take 9ml of saline solution to get 10 ml of adrenaline diluted 1 / 10,000
+ Technique of Adre nalin inje ction :
First, use an injection containing 10ml of adrenalin solution
to inject around the ulcer causing bleeding
With Forrest IA and IB ulcers, inject around the bleeding s ite until the mucosa swells with volumes for a injections ranges 0.5-3 ml
With Forrest IIA ulcer, inject 4 positions around the ulcer with dose is 0.5 - 3 ml
With Forrest FIIB ulcer having blood clot, inject to remove the clot, inject around the location of blood clot, the dose of each injection is 0.5 - 5 ml until the mucosa swells As a result, blood c lot
Trang 10may pop out and convenient for washing and removing the clot Then, the ulcer is performed a washing pump to reveal , if blood clots remain on the ulcer, the blood c lot must be removed, firstly,The ulcer is flushed with strong pressure, if the blood clot does not turn out, snares , pliers or three prong pliers were used to take out the objects
Claming clip is performed additionally after injecting adrenalin If it fails, the blood continues to flow, requiring Consultation to another method of treatment is required (vascular intervention, or surgery)
2.2.4 Ide ntify results
2.2.4.1 Crite ria for first hemostasis (imme diate he mostasis)
The first period is evaluated by endoscopic images right after the end of the procedure, with pictures:
+ Blood does not flow: After the procedure is performed, the results are successful immediate ly They include the image of blood from the ulcer does not flow, wash and clean the bottom ulcer, follow after that, blood bleeding is not see
+ Blood flow does not hold: the results is failure after performing the procedure as well as the blood still flow, physician must coordinate other endoscopic interventions such as adrenalin 1/1000 injection After the combination treatment is performed, physician must check again if the ulcer is no longer bleeding, treatment has been successful
+ Blood flow without holding, vascular intervention or surical method: After using other endoscopic interventions, the blood continues to flow, vascular intervention or surgical surgery must be performed immediately
2.2.4.2 Evaluate res ults afte r he mostasis:
Based on clinical and investigation:
The first hemostatic result:
Trang 11+ Success: when the first colonoscopy was successful, the clinical condition of patients is stable, there is not vomiting blood, defecation is yellow stool
+ Failure: when the first endoscopy must use other hemostatic measures or surgical transfer or in case the patient has recurrent bleeding with clinical signs :vomit blood, go outside the black stool, pulse fast, low blood pressure and endoscopy immage with recurrent bleeding ulcer must be intervened several times
The second hemostatic result:
Evaluate the results of hemostasis when the patient has recurrent bleeding, with the same criteria as the first hemostasis assessment
2.2.4.3 Evaluation of ge ne ral he mostatic results
As a general assessment of the results through hemostasis:
+ Good: Only one intervention has to be conducted, the
results are successful immediately, the ulcer is not bleeding, clinical monitoring is stable, stool is yellow
+ Average: Patients with recurrent bleeding, but through
successive hemostasis, clinica l monitoring is better , without bleeding, defecation
+ Poor: Hemostatic procedure failed, other endoscopic
intervention must be used or the patient must switch to vascular intervention or surgery, or the patient has severe fatalities, the procedure is not achieved
2.2.4.4 Crite ria of Technical and s afe ty evaluation
- Evaluation of technical complications: perforation when rough intervention, seeing tools through ulcers or exposed lateral lesions, necrosis
Trang 12- Assess the condition of pulse, blood pressure before and after intervention
2.2.4.5 Comparison of e ffe ctive hemostasis: clip alone and clip
combinate d with adre nalin 1/10000 injection
+ Compare the successful hemostatic rate between the two methods after performing the procedure
+ Compare the rate of recurrent bleeding between the two methods
+ Compare hemostatic results of two methods when patients leave the hospital
+ Compare the amount of blood transmitted to the patient between the two methods
+ Compare length of hospital stay between two methods + Technically: Compare the average number of clips used for each technique The average total of adrenalin solution injections and the total mean volume (ml) of adrenalin 1 / 10,000 solution for the combined treatment group (group II)
2.2.5 Using a scale to assess the risk of recurre nt GI bleeding,
the risk of de ath afte r tre atme nt
According to the guidelines for treatment for pateint with GI bleeding which not due to by portal hypertension, there are 2 commonly used scales: Full Rockall scale and Blatchford scale
2.2.6 Data processing
Data is processed according to the medical statistical method with the help of 20.0 SPSS software and processed at the Institute of Preventive Medicine Training and Public Health, Hanoi Medical Univers ity
Trang 13Chapte r III RESULTS
GROUP
Average age, rate of male and female, history of gastrointestinal bleeding (first, second, over 2 times), comorbidities and drug history between two different groups were not statistically significance (p> 0.05) Clinical symptoms (abdominal pain, vomiting blood, go outside black stool), classify the level of blood loss in clinical (severe, moderate, mild), the number of peptic ulcer (1 drive,
2 drives, on 2 drives), position of peptic ulcer (stomach, duodenum), stomach-duodenal ulcer size (<1 cm, 1-2 cm,> 2 cm), different between 2 groups were not statistically significance (p> 0.05)
GROUPS
3.2.1 Evaluate first he mostatic res ults (1 st )
Table 3.11 first he mostatic res ults of two groups
He mostatic results Plus
75 (100%)
0,013b Failure 7 (4,7%) 7 (9,3%) 0 (0%)
Plus (100%) 150 (100%) 75 75 (100%)
b: Fisher's Exact Test
Comme nt:
- Hemostatic effect of group II: 75/75 patients (100%)
- Successful hemostatic effect of group I: 68/75 patients (90.7%)