Comparision of the hemostatic efficacy from the combined bipolar probe coagulation with epinephrine injection and the bipolar proble coagulation alone in the treatment of peptic ulcer bleeding

Nội dung text: Comparision of the hemostatic efficacy from the combined bipolar probe coagulation with epinephrine injection and the bipolar proble coagulation alone in the treatment of peptic ulcer bleeding

1. Journal of military pharmaco-medicine N o7-2016 COMPARISION OF THE HEMOSTATIC EFFICACY FROM THE COMBINED BIPOLAR PROBE COAGULATION WITH EPINEPHRINE INJECTION AND THE BIPOLAR PROBLE COAGULATION ALONE IN THE TREATMENT OF PEPTIC ULCER BLEEDING Le Quang Duc*; Tran Viet Tu**; Nguyen Quang Duat** SUMMARY Objectives: This study compared the combined bipolar probe coagulation with epinephrine injection during endoscopic process with the bipolar probe coagulation alone in the treatment for patients suffering from peptic ulcer bleeding. Subjects and methods: Patients who were endoscopically confirmed of peptic ulcer bleeding (active or visible vessel) during the period from January, 2010 through December, 2014, were prospectively randomized into two groups. The control group was treated by the bipolar probe coagulation alone (group 1); and the study group was treated by the combined bipolar probe coagulation with epinephrine injection during the endoscopic process (group 2). The primary outcomes, in terms of initial hemostasis, rate of recurrent bleeding within 72 hours, blood transfusion volume after the intervention, duration of hospital stay, and the potential risk of blood transfusion after the intervention were assessed. Results: The common rate of initial hemostasis was 97.5% (95.1% and 100% in group 1 and 2, respectively); the rate of recurrent bleeding in group 1: 5.2%, and group 2: 0% showing the remarkable success of hemostasis in group 2 (100%) compared to group 1 (90.2%) (p = 0.043); the blood transfusion after the intervention in group 1 and 2 were 792.9 ± 125.56 (p = 0.370) and 557.7 ± 41.76 mL, respectively; duration of hospital stay were 9.6 ± 3,01 and 8.9 ± 3.12 days (p = 0.167). As such, the combination method showed the reduction of the potential risk of blood transfusion after the intervention from 1.28 - 1.39 times in comparison with the bipolar probe coagulation alone method. Conclusion: The combined bipolar probe coagulation with epinephrine injection during the endoscopic process was proved more effective than the bipolar probe coagulation alone in the treatment of patients suffering from peptic ulcer bleeding. * Key words: Peptic ulcer bleeding; Hemostasis; Electrical oagulation. BACKGROUND in which coagulation injection and probe coagulation are commonly used [2]. Recently, Peptic ulcer bleeding is a common some activists have conducted the emergency, and can be life-threatening if patients are not treated timely. Endoscopic combination method and observed the hemostasis is an effective treatment method effectiveness in hemostasis for peptic for peptic ulcer bleeding reducing the ratio ulcers [7]. However, there has not been of dead and surgery [2, 4, 6]. There are any study discussing and comparing many methods of endoscopic hemostasis, the effectiveness among these methods. * Haiduong General Hospital ** 103 Hospital Corresponding author: Le Quang Duc (bsquangduc@gmail.com) 22
2. Journal of military pharmaco-medicine N o7-2016 Therefore, this study is aiming at: Probe coagulation was conducted after Compare the hemostatic efficacy between that around or directly into the vessels the bipolar probe coagulation alone and or the bleeding point with the intensity of the combined bipolar probe coagulation 10 - 15 in 5 - 10 seconds. The entire with epinephrine injection during the intervention was implemented using the endoscopic process. Olympus-CV 240 endoscopic system, the ICC-ERBE 300 probe coagulation system, SUBJECTS AND METHODS the bipolar interject gold probe (Boston 1. Subjects of the study. Scientific) which is the probe association 122 selected patients among 1,252 with the injection needle and the probe patients suffering from peptic ulcer bleeding coagulation needle. Patients were clinically who were being treated at the Internal monitored, re-tested, screened after 72 hours. Digestive Department of the General If bleeding recurrence was found, endoscopic Hospital of Haiduong from 01 - 2010 to hemostasis shall be applied again. 12 - 2014. * Criteria for evaluation: * Diagnostic criteria: Symptoms including - Primary hemostasis: (1) Hemostasis: vomiting of blood or black stool; active no evident of bleeding via endoscopic bleeding of Forrest IA, B showed in after the last hemostasis: no flow of blood; endoscopy taken within 24 hours after (2) If the bleeding is on-going: other admission, and the ulcer with high-risk of endoscopical hemostasis shall be conducted Forrest II A, B. (such as combination of injection and probe * Exclusion criteria: Peptic bleeding coagulation or clip hemostasis, etc.); (3) If by no ulcer, bleeding ulcer with clean the bleeding keeps going: patient shall be intervented by surgery. Monitoring of bottoms, large ulcers by stomach cancer, bleeding recurrence based on the symptoms patient who does not agree to participate such as vomiting of red blood or the study. discharging of black tool, or continuous 2. Methods. reduction of Hb within 24h. If the bleeding * Study method: Patients were selected recurrence was suspicious, endoscopic in the two groups in the form of coupling, would be conducted again right away and based on classifications by gender and the treatment would be taken again from age: alone method group (group 1) and the beginning. the combined method group (group 2). - Assessment after 72 hour: (1) Good The epinephrine injection was conducted (entire ulcers was hemostasised, no evident before the probe coagulation. The step of of bleeding); (2) Average (primary hemostasis, conduction included: using the 25G needle bleeding recurrence afterward causing associating with the gold probe (7 Fr) to reintervention, then being success within inject a dose of 1 - 2 mL adrenalin 1/10.000 72 hours); (3) Poor (hemostasis failed at into 4 plots around the bleeding point. the primary endoscopical intervention and 23
3. Journal of military pharmaco-medicine N o7-2016 other method had to be used including transfused blood, duration of hospital surgery, or the patient was dead). stays and some other criteria were included. Assessment of hemostasis (first time, The studied data were processed by second time or third time if bleeding SPSS 15.0 using percentage algorithm (%,) recurrence over and over): “Success” if no average algorithm accepting standard blood flow was found; “Fail” if bleeding is deviations, % comparison, and average on-going or recurrent. Assessment of values. Test t-student was used for square intervention duration; assessment of the algorithm and Mann-Whitney was used with ratio of recurrent bleeding, the volume of appropriate deviations for accreditation test. RESULTS 1. General features. Table 1: Age, gender and the status of blood coagulation before intervention. Research targets Total, n (%) Group 1, n (%) Group 2, n (%) p 55.4 ± 16.83 55.4 ± 16.78 55.3 ± 17.02 Average age 0.957 (15 - 91) (15 - 87) (15 - 91) Gender (male/female) 61/38 42/19 42/19 1 Male patients took 68.9%. Male/female ratio = 2.2/1. There was no difference in terms of age and gender between the two groups. Table 2: RBC count, hemoglobin and hematocrit concentration, and blood transfusion before intervention. Features Total Group 1 Group 2 p 2.9 ± 0.91 2.8 ± 0.92 2.9 ± 0.90 Volume of erythrocytes (T/L) 0.729 (1,11 - 1,53) (1.11 - 5.13) (1,38 - 5.06) 82.7 ± 25.90 79.7 ± 24.47 85.8 ± 27.12 Concentration of hemoglobin (g/L) 0.200 (25 - 144) (25 - 138) (41 - 144) 25.5 ± 7.66 24.9 ± 7.38 25.9 ± 7.95 Hematocrit (%) 0.450 (10.2 - 43.5) (10.2 - 42.2) (12.8 - 43.5) Ratio of blood transfusion before 80/122 44/61 (72.1%) 36/61 (59.0%) 0.127 intervention (65.6%) n = 54 n = 30 n = 24 Volume of blood transfusion before 502.8 ± 23.95 533.3 ± 33.33 464.58 ± 33.31 0.423 intervention (mL) (250 - 1,250) (250 - 1,250) (250 - 750) There was no difference in terms of volume of hemoglobin as well as volume of blood transfusion between the two groups before and after intervention. The ratio of patients who had blood transfused as well as volume of blood transfusion before intervention also showed no difference. 24
4. Journal of military pharmaco-medicine N o7-2016 Table 3: Endoscopic picture before hemostasis. Endoscopic pictures Total Group 1 Group 2 before hemostasis n (%) n (%) n (%) p Forrest classification Forrest IA 2 (1.6) 1 (1.6) 1 (1.6) 1 Forrest IB 39 (32.0) 20 (32.8) 19 (31.1) 0.845 Forrest IIA 28 (23.0) 14 (23.0) 14 (23.0) 1 Forrest IIB 53 (43.4) 26 (42.6) 27 (44.3) 0.856 Total 122 (100) 61 (100) 61 (100) Location of ulcer Stomach 30 (24.6) 17 (27.9) 13 (21.3) 0.400 Duodenum 86 (70.5) 41 (67.2) 45 (73.8) 0.427 Stomach + duodenum 6 (4.9) 3 (4.9) 3 (4.9) 1 Ulcer size < 1 cm 25 (20.5) 12 (19.7) 13 (21.3) 0.823 1 - 2 cm 91 (74.6) 46 (75.4) 45 (73.8) 0.836 > 2 cm 6 (4.9) 3 (4.9) 3 (4.9) 1 Endoscopic pictures were mainly seen in Forrest IB, IIA and IIB with respective ratios 32.0%, 23.0% and 43.4%. The ratio of Forrest IA was rarely seen taking only 1.6%. There was no difference between the two groups in terms of bleeding level. The common location of ulcer was seen at duodenum. The ratio ulcer location at duodenum/stomach = 2.4/1. Ulcer sizes of about 1 - 2 cm took 74.6%. There was no difference between the two groups in terms of location and size of ulcer. 2. Results from the endoscopic intervention. Table 4: Pictures of primary hemostasis. Hemostatic result Total, n (%) Group 1, n (%) Group 2, n (%) p Picture of primary hemostasis Complete hemostasis 119 (97.5) 58 (95.1) 61 (100) 0.079 Incomplete hemostasis 3 (2.5) 3 (4.9) 0 On-going bleeding 0 0 0 Ratio of bleeding recurrence Yes 3 (2.6) 3 (5.2) 0 0.072 No 116 (97.4) 55 (94.8) 61 (100) 25
5. o Journal of military pharmaco-medicine N 7-2016 Results from the first time hemostasis Success 116 (95.1) 55 (90.2) 61 (100) 0.012 Fail 6 (4.9) 6 (9.8) 0 General results of hemostasis Good 116 55 (90.2) 61 (100) Average 3 3 (4.9) 0 Poor 3 3 (4.9) 0 The ratio of complete hemostasis after intervention was 97.5%, in which group 1 was 95.1%, group 2 was 100%. 4.9% in group 1 showed incomplete hemostasis therefore other endoscopic hemostasis methods were mobilized. There was no case of impossible intervention via endoscopy. Group 1 showed the bleeding recurrence ratio of 5.2%, which reflected no statistical meaning of p = 0.072 in comparison with group 2. Table 5: Volume of blood transfusion after intervention and the duration of hospital stays. Feature Total (n = 54) Group 1 (n = 28) Group 2 (n = 26) p Volume of blood transfusion 679.6 ± 510.23 792.9 ± 664.40 557.7 ± 212.92 0.091 after intervention (250 - 3,000) (250 - 3,000) (250 - 1,000) 9.3 ± 3.07 9.7 ± 3.01 8.9 ± 3.04 Duration of hospital stays 0.167 (3 - 22) (4 - 18) (3 - 22) There was no difference in terms of volume of blood transfusion and duration of hospital stays between the two groups. 3. Assessment of risks factors after intervention. Table 6: Ratio of required blood transfusion among the sub-groups of light and heavy blood lost. Ratio of required blood transfusion HR Group 1 (n = 30) Group 2 (n = 24) Group with high blood lost (required p1 = 16/30 (53.3%) p2 = 10/24 (41.7%) p /p = 1.28 blood transfusion before intervention) 1 2 Group with low blood lost (no requirement n = 31 n = 37 p /p = 1.39 of blood transfusion before intervention) 1 2 p1 = 14/31 (45.2%) p2 = 12/37 (32.4%) Group with high blood lost: risk of blood transfusion again in group 1 was 1.28 time higher than group 2. Group with low blood lost: risk of blood transfusion again in group 1 was 1.39 time higher than group 2. 26
6. Journal of military pharmaco-medicine N o7-2016 DISCUSSION The observation of endoscopical pictures 1. General features. showed no difference in terms of ulcers’ characteristics. *Age and gender: Average age of the studied groups was 2. Results from the endoscopic 55.4 ± 16.83, the youngest was 15 and intervention. the highest was 91 years old. Among the Results from endoscopic intervention 122 patients, male took 68.9%, male/female were assessed based on the primary ratio = 2.24. This ratio was similar with the hemostasis. The overall results from the ratio of the studies from in-country activist combined groups reached 100%. The bipolar such as Tran Viet Tu [3], and from out- probe coagulation alone group reached country activist such as Bianco et al 95.1%; the other 4.9% of patients was 75% [5], Chau et al 64.9% and 70,5%, seen on-going bleeding, therefore other Soon et al 73.0% [9]. There was no endoscopic hemostatic methods including difference in terms of average age and hemostatic injection and clipping were gender ratio between the two studied applied. groups. Although the intervention of endoscopic * Clinical and subclinical features: alone was effective in the treatment of ulcer in stomach and duodenum, a small Regarding the CBC value, average recurrent ratio remained [2]. As such, later hemoglobin concentration was 82.8 ± studies tried to improve the results by the 25.91 g/L, similarly to the study taken by combined methods. Based on different Bianco [5]. Results showed that majority hemostatic theories, adrenalin was proved of patients suffered from average to high to be the active factor for hemostasis blood lost levels and this feature is shown inside the endogenous arteries resulting similarly in both groups. vasoconstriction and therefore making it * Characteristics of peptic ulcers: easier for coagulation. The thermal probe In this study, the endoscopic pictures can result in the artery inflow causing were mainly Forrest IB, IIA and IIB with organizational coagulation and therefore respective ratios of 32.0%, 23.0% and activate the coagulation in the arteries 43.4%. The ratio of Forrest IA was rarely and cause the swelling which help to seen taken 1.6%. Majority of ratios were pinch the artery. Via each probe point, the similar to the studies conducted by in and blood flow would be seen decreasing and out country activists, but showed lower coagulating completely [4, 6]. This study ratio of Forrest IA compared with the showed the good result on 100% of studies conducted by Dao Van Long [1], patients in their initial hemostasis. This Tran Viet Tu [2]. Ulcer size of more than result fit with the conclusion by Bianco 1 cm took 79.5% associating with potential and Chau confirming the role of adrenalin risk of bleeding and high blood lost. associating with other methods [5]. 27
7. Journal of military pharmaco-medicine N o7-2016 The long-term hemostasis was assessed CONCLUSION by the clinical criteria such as color of The bipolar probe coagulation alone discharge of patients was gradually brighten and the combined bipolar probe coagulation and the picture of ulcer bottom was clean. with epinephrine injection were proved to After 72h, patients were re-endoscopically be effective in treatment of peptic ulcer tested. The general hemostatic result in bleeding. Particularly, the combination the combined group was 100% good. of the bipolar probe coagulation alone 3. Assessment of post-intervention associating with adrenalin injection during risks. the endoscopic process showed better The result showed that the primary result. 100% of patients enjoyed the hemostasis in the combined group was complete hemostasis only after the first remarkable good compared to the bipolar intervention reducing the risk of blood probe coagulation alone group. The analysis re-transfusion after intervention from of post-intervention criteria such as the 1.28 - 1.39 compared to the bipolar probe duration of hospital stays and the volume coagulation alone. of blood transfusion after the intervention were conducted. However, no difference REFERENCES in terms of statistical meaning were found. 1. Dao Van Long, Vu Truong Khanh et al. The volume of blood transfusion in the Assessment of results of hemostasis using combined group was lower than the other adrenalin 1/10.000 injection during endoscopic groups (p = 0.167). By deeply analyzing process in association with high dose of this criterion, the data in the table 6 rabeprazole in intravenous for patients of showed that the hazard ratio (HR) was peptic ulcer bleeding. The Vietnam Journal of Digestive Science. Episol VII. 2012, No 28, increased from 1.28 to 1.39. It means that pg.1827-1834. the risk of blood transfusion in the group 1 2. Le Quang Duc, Tran Viet Tu, Nguyen is higher than in the group 2 from 1.28 Quang Duat. Treatment of peptic ulcer (in the sub-group with high blood lost - bleeding due to ulcers in stomach and need blood transfusion before intervention) duodenum by the bipolar probe coagulation to 1.39 (in the sub-group with low blood lost - during endoscopic process. Journal of Vietnam no blood transfusion before intervention Medicine. 2014, No 2, pp.58-61. was needed). This parameter once again 3. Tran Viet Tu. Study of effectiveness of proved the effectiveness of the combined some injection liquids using for hemostasis bipolar probe coagulation with epinephrine during endoscopic process in the treatment of injection in the treatment for peptic ulcer peptic ulcer bleeding. Medical doctorate thesis. bleeding. Military Medical University. 2004. 28
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