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COMPARATIVE ANALYSIS OF PROGNOSTIC SYSTEMS IN PATIENTS WITH RELAPSE OF GASTRODUODENAL BLEEDING


Lebedev Nikolai V. -�Doctor of Medical Sciences, Professor.�Works at the Department of Surgery of Peoples� Friendship University Russia.�Address (home): 123060, Moscow, Marshal Birjuzova, 22, Bldg.�3, square 84. Tel: work - 1359125, cell: 89175989015;�House 8 -194-499-82-65.�(E-mail�address:nickl55@mail.ru�)

Klimov Alexei E.�- Doctor of Medical Sciences, professor, Head of the Department of Surgery of Peoples  Friendship University Russia.�Moscow, Vavilova Street 61, tel.�135-91-87, (E-mail:  HYPERLINK "mailto:klimov.pfu@mail.ru" \h klimov.pfu@mail.ru).


Barkhudarov Alexander .- PhD, Associate Professor in Faculty of Clinical Surgery of Peoples� Friendship University Russia. 8-926-160-35-67 (E-mail:  HYPERLINK "mailto:ulbak@yandex.ru" ulbak@yandex.ru)

Sokolova Polina U. -�Postgraduate student of the Department of Surgery of Peoples� Friendship University Russia.�8-985-435-36-94�(E-mail:  HYPERLINK "mailto:sokolovapu@gmail.com" \h sokolovapu@gmail.com)


Ankit Paul D. - Postgraduate student of the Department of Surgery of Peoples� Friendship University Russia.�8-926-897-70-18 (E-mail:  HYPERLINK "mailto:ankitpaul.paul8@gmail.com" \h ankitpaul.paul8@gmail.com )











Abstract

Purpose:
The aim of our study was to conduct a comparative evaluation of modern prognostic systems for gastroduodenal ulcer bleeding relapse.
Methods:
The material for this clinical research was the results of treatment of patients in the surgical clinic of Russian University of Peoples' Friendship (RUDN). The research included 737 patients with gastroduodenal bleeding with ulcers as the main etiology in the period of 2005 to 2012.�For comparative evaluation systems that were considered were most commonly used in Western countries�T.A. Rockall, O.�Blatchford,�as well as the Russian system of analysis of re-bleeding N.V.�Lebedev (SPRB), M.M.�Vinokourov, I.I.�Zatevahina, E.D. Fedorov.
Results:
None of the six studied scales that predict the ulcer re-bleeding includes high optimal research values, which is probably due to the impossibility of applying the mathematics rules to a complex biological system like the human body.
Conclusions:
When choosing a treatment strategy we should focus on the scale which allows predicting most accurately the group of patients with high risk of re-bleeding.�This characteristic has developed at the Department of Surgery RUDN, system of prognosis of re-bleeding (SPRB).
Keywords:
Gastroduodenalulcers. System of prognosis of re-bleeding.

































Authors� Contributions

Lebedev Nikolai V. - Study conception and design, analysis and interpretation of data, drafting of manuscript.
Klimov Alexei E. - Critical revision of manuscript.
Sokolova Polina U. - Acquisition of data, analysis and interpretation of data.
Barkhudarov Alexander�. - Acquisition of data.
Ankit Paul D.-�Acquisition of data, drafting of manuscript.

�










































In Russia, the number of patients with gastroduodenal bleeding ranges about 90-160 per 100,000. [1,2,3,4]; [4].�In the structure of complicated forms of peptic ulcer gastrointestinal bleeding leads, accounting to 42-47% [3,5].
According to V�Congress of Surgeons held in Moscow (2013) in the period of 2008 to 2012, 18,446 patients were treated in the treatment and prophylactic centers of Moscow regarding gastroduodenal ulcer bleeding.�During this five-year period there has been a decrease in total mortality rate from 5.3% to 3.0%, especially in hospitals where a decrease in the operational activity changed from 16.3% to 13.9% [6].
At the present level of surgery, therapeutic endoscopy, intensive care, antisecretory drugs relapse of peptic ulcer hemorrhage occur in 5-35% [5,7,8,9,10,11].�In this case, mortality in recurrent hemorrhage is increased up to 30-40% [8,12,13], and postoperative-more than 50% [14,15,16].
Modern algorithms of treatment of patients with ulcer bleeding are mainly aimed at solving problems of its recurrence.�In cases where the bleeding fails to stop endoscopically or transcatheter embolization then no doubt �indicated surgical treatment.�After successful stoppage of bleeding, determined the likelihood of recurrence of bleeding followed by differentiated approach to the treatment.�In this situation, the question of determining the indications for surgery and duration of its implementation is a key issue in the treatment of patients with gastroduodenal ulcer bleeding.�If the surgeon is able to predict with reasonable certainty the future course of events (in this case the probability and time of recurrent ulcer bleeding), he will not face the eternal/constant question of the need of operation and optimal duration of its implementation.�In this regard, it is extremely important to use re-bleeding forecasting systems and the enhance the methods of its prevention.
The complexity in prevention relapses of gastroduodenal ulcer hemorrhage compounded by the lack of clear criteria predicting the probability of re-bleeding [15,17, 18].
In order to predict the likelihood of recurrence of ulcer bleeding, a huge number of methods based on specific prognostic factors, their aggregate or complex mathematical analysis.�However, studies comparing the existing systems are very few, and the conclusions of the authors raise more questions than answers [19, 20].
The aim of our study was the comparative evaluation of the current systems to predict the recurrence of ulcerative gastroduodenal bleeding.
Materials and methods
The clinical material of this research was the results of treatment in the clinic of Surgery, Russian University of Peoples' Friendship. The research included 737 patients with gastroduodenal bleeding with ulcers as the etiology in the period of 2005 to 2012.�Male patients accounted for 477 (64.7%), women - 260 (35.3%).�Ratio of men to women comes out to be 477: 260 (1.8: 1).�The age of patients ranged from 14 to 97 years (mean age 59,4 � 18,9 years), with more than 50% patients elderly (over 60 years).
All patients within the first hour from the time of hospitalization underwent esophagogastroduodenoscopy (EGD).�Bleeding intensity evaluation was carried out by endoscopic classification J.�Forrest [21].�Continued�bleeding jet�(FIA)�was diagnosed in 61 (8.3%) patients, the�continued capillary bleeding�(FIB)�- in 124 (16.8%) patients.�Consisting bleeding�FIIa�- in 168�(22, 8%),�FIIb -�in 104�(14,1%),�FIIc -�in 280 (38.0%) patients.
In primary endoscopy 440 patients (59.7%) performed endoscopic hemostasis.�The most commonly used argon-plasma coagulation - 294 cases (40%) and combined hemostasis (injection method + argon-plasma coagulation) - 113 (15.33%), in 297 patients (40.3%) taking into account the low risk of re-bleeding endoscopic hemostasis is not performed.�After endoscopy was calculated the risk of recurrence of bleeding by the method of system of prognosis of re-bleeding (SPRB), developed at the Department of Surgery People's Friendship University, as well as on the severity of the condition based on�SAPSII�scale.
All patients underwent antisecretory therapy, 71.6% used drugs from the group of proton pump blockers (Losek, Ulkozol, Ultop, Omez, Nexium), in 15.3% of cases used drugs from the group of H2 receptor blockers (Kvamatel, Ranitidine).�In 13.1% of patients used a complex therapy with both the groups.
Re-bleeding was observed in 117 cases (15.9%), 74 men (63.2%) and 43 females (36.8%).�Male to female ratio of 1.7: 1, this is identical to the distribution by gender in the whole study group.�Bleeding from gastric ulcers recurred in 18% of cases and of duodenal ulcers in 14.4%.
Relapse was observed in all types of bleeding by�Forrest,�however more than half of recurrences developed against the background of the initial bleeding intensity�F1 (51.3% of recurrent hemorrhage).
For comparative evaluation systems considered the most well-known and frequently used scale abroad�T.A.�Rockall[22], O. Blatchford[23],�as well as the Russian system of re-bleeding�forecast: Developed in the clinic of Surgery of the Russian Peoples' Friendship University, system of prognosis of re-bleeding (SPRB) [15] ( Table 1.2), M.M.�Vinokourov [24] (Table 3), I.I.�Zatevahina [7] (Table 4) and E.D.�Fedorov [25] (Table 5).
Table 1
System of prognosis of recurrent gastroduodenal bleeding (2010)�*
�
SignCriterionPoints�
Age
(years)Up to 31
31-50
51-70
older than 701
2
3
4LocalizationStomach
Duodenum1
2�
Ulcer size (mm)Up to 5
6-14
15-24
e"�251
2
3
4�
Blood pressure (syst.)e"�120
90-119
61-89
d"�601
2
4
6�
Heart rate (beats / min)Up to 80
81-110
111-140
> 1401
2
3
4�
�
ForrestF2c
F2b
F2a
F1b
F1a1
2
3
4
5Type of endo-hemostasis (for chronic ulcers)AIC
Other (other than clipping)2
3Antisecretory therapyProton pump inhibitors
H�2�blockers1
2* All methods of endoscopic hemostasis in acute ulcers are estimated as 1 point.
Endoscopic clipping is not included in the system of prognosis of bleeding relapse, as it is not always possible to clearly see the bleeding vessel and (or) firmly set on clips on the bleeding vessel due to  fibrous tissue changes in the depth of callous ulcers.
The fundamental difference between the proposed system SPRB with others is to explore the possibility of taking into account the treatment (variants of endoscopic hemostasis and antisecretory therapy), the most important factor preventing recurrent bleeding.
�
Table 2
Quantitative prediction of re-bleeding gradation system determine the probability of recurrent bleeding and lethal outcome
Score SPRBThe probability of relapse (%)The probability of lethal outcome (%)8 � 10--11 - 13610.414 - 1612.22517 - 182732.419 - 2033.341.721 - 225066.62385.786.424 or more100100�
As can be seen from Table 2, with an increase in SPRB points increases the likelihood of recurrent bleeding, reaching the score 24 or more is an absolute indication of high probability of relapse as well as high probability of lethal outcome.�Using the developed system can also be predicted the probability of death in patients, it is often associated not only with the loss of blood, but also to the severity of comorbidities.�The reliability of the prognosis using the SPRB with 10 or less point and 24point or more is 100%.�During assessment of recurrent bleeding from 11 to 23 points the accuracy is 93 - 94%.
Table 3
Scale counting signs of bleeding to identify indications for urgent surgical treatment and determine the probable re-bleeding [24]
SignPointsAge of the patient, years�15 to 3010from 31 to 60561 and over5Melena and / or hematemesis more than 2 times per day5Hemoglobin less than 100 g / l, erythrocyte less than-�2.5x1012�/ l5BP below 80/40 mm.Hg, heart rate over 100 per minute5Localization of ulcer�The rear wall of the intestine duodenum10Lesser curvature of the stomach10The rear wall of the stomach10Ulcers Size, cm�Stomach 210Stomach 220Duodenum ulcer 1.520Endoscopic picture�F1A20F1B15F2A10�
Table 4
The relative signs of the threat of bleeding and scores [7]
IndexCriterionPointsClinical characteristics of bleedingThe high intensity of bleeding or a history of collapse1Endoscopic hemostasis characteristicsAny bleeding stopped endoscopically, or the presence of thrombosis vessels in the ulcer or ulcer, covered with blood clot (thrombus)1Endoscopic ulcers characteristicDiameter 1.3 cm ulcer 0.8 cm or more for duodenal ulcers.11�.��������Recurrence of bleeding is predicted in the presence of 2 or 3 points.
2�.��������Of the forecast period - the first 10 days from the date of receipt of the patient in the hospital.�
Table 5
Re-bleeding risk assessment [25]
SignCharacteristicPointsSigns of hemorrhagic shock pre-hospitalNo-1Yes2Liver DiseaseNo0Yes6Heart rate100-1More than 1003The admixture of blood in gastric contents on probingNo-6<150+1150-5003> 5005The deficit blood volume<10%010 - 20%2> 20%5The depth of duodenum ulcerd"�4-1> 45The depth of gastric ulcers
�d"�6-1> 65�
Comparative analysis proceeded from the authors recommended interpretations of scales (the recommended score high risk of re-bleeding).�The threshold values of high probability of recurrent bleeding were:
-�System T.A. Rockall -�6 points or more,
-�System �O. Blatchford -�6 points or more,
-�System M.M.�Vinokourov - 55 points or more,
-�System I.I.�Zatevahina - 2 points or more,
- SPRB�- 17 points or�more,
-�System E.D.�Fedorov - 0 points or�more.
The analyzed systems were compared for reliability - the sensitivity and specificity [27]
Reliability - a quantity that characterizes the ability of a method to distinguish healthy from the sick.�It includes two components: sensitivity and specificity.
Sensitivity - The probability that a patient with suspected recurrent hemorrhage is really present or not.�Determined by the formula:
Sensitivity = True-positive / True-positive � Pseudo-negative x 100
�
Specificity - The probability that a patient without the risk of re-bleeding is actually not present.�Measured according to the formula:
Specificity = True-negative / True-negative + Pseudo-positive x 100
�
Also to evaluate error probability characterizing the extent to which the next subsequent observations confirm prognosis phenomenon.�For such characteristics prognosis, Panofsky G.A.�term accuracy was proposed in 1967[28]
Accuracy - the percentage of coincidence of results of follow-up, confirming the prognosis of a certain phenomenon.�Determined by the formula:
Accuracy = True-positive + True-negative / Total x 100
�Sensitivity and Specificity describe the accuracy of the systems studied.
R. Greenberg et al.�(2001) suggested the use of two additional indicators to assess the likelihood of disease (gastroduodenal bleeding in this study) - a positive predictive evaluation (PV+) and negative predictive evaluation (PV-) [29].
Results of the study
In the entire group of patients (737 people) determines the risk of recurrence of gastroduodenal ulcer bleeding on the scale described above.
The main results of the comparative analysis of the test prediction systems are presented in Table 6.
Table 6
The results of the comparative analysis of relapse prediction systems gastroduodenal bleeding�(n�= 737)
�
�
ScaleSensitivity%Specification%Accuracy%�PV+%PV-�%LR+LR-T.A.�Rockall,�199654.755.755.518.886.70.230.15I.I. Zatevahin 199760.763.563.523.989.50.310.12. latchford, 200072.748.15220.990.30.270.11E.D. Fedorov 20026562.462.824.692.10.330.11M.M. Vinokurov 200825.695.584.451.787.21.460.15SPRB (N.V. Lebedev, 2010)60.77068.545.290.40.380.11�
It is clear from Table 6 that scale T.A.�Rockall�relative to other scales has lower performance and reliability (sensitivity 54.7%, specificity 55.7%) and accuracy (55.5%), and predictive assessment (PV+�18.8%�PV-�86.7%) and low refractive�LR+�(0.23) and the largest exponent�LR-�(0.15).�Thus, to predict the likelihood of recurrence of bleeding from gastroduodelnal ulcer scale T.A.�Rockall is�impossible.
Higher rates has I.I. Zatevahina Scale�(sensitivity 60.7%, specificity 63.5%, accuracy 63.5%), indicators of predictive assessment and likelihood ratios are comparable with those of the scale T.A.�Rockall.
Possess the most sensitive scale�O.Blatchford and�E.D. Fedorova (72.5 and 65%, respectively), in the same scale have the highest negative predictive performance assessment (PV-) - 90.3% and 92.1%.�In other words, the negative of these scales virtually eliminates the likelihood that the patient had a relapse of gastroduodenal bleeding.�However, the specificity and positive predictive score in the above scales are among the lowest (O. Latchford scale�- 48,1%, 20,9%,�the scale of E.D. Fedorov - 62.4%, 24.6%).
The highest specificity has M.M.�Vinokourov and SPRB scale (95.5% and 70%, respectively).�Also, these scales observed the highest rate of positive predictive evaluation (PV+) 51.7% and 45.2%, and accuracy (84.4 and 68.5%, respectively).�Thus, the positive result of these systems involves a high risk of re-bleeding.
In addition, M.M. Vinokurova scale has the highest rate�LR+�1.46, but it loses much the rest of the scales in their sensitivity (the sensitivity of the scale M.M. Vinokurova 25.6%) and has the highest indicator of the likelihood ratio (LR-�0.15), and hence cannot identify a group of patients with a low risk of re-bleeding.
The percentage of agreement of the results of follow-up, confirming the prognosis of certain phenomena (accuracy) scales M.M. Vinokurova and SPRK (84.4% and 68.5%, respectively) are also higher than those of other scales.
We have also conducted comparison of sensitivity and specificity performance scales with this prognosis, the authors of systems reliability indicators (table 7).
�
Table 7
Comparison of reliability indicators
�
ScaleOur findingsRespective authorT.A.�Rockall,�1996The sensitivity of 54.7%
The specificity of 55.7%No dataI.I. Zatevahin 1997The sensitivity of 60.7%
Specificity 63.5%Reliability 92%A.�Blatchford,�2000The sensitivity of 72.7%
The specificity of 48.1%Sensitivity 99%
Specificity 32%E.D.�Fedorov 2002Sensitivity 65%
The specificity of 62.4%Sensitivity 82%
Specificity 74%M.M. Vinokurov 2008Sensitivity 25.6%
Specificity 95.5%No dataSPRB (N.V. Lebedev, 2010)The sensitivity of 60.7%
Specificity 70%The reliability of 93-94%�
Out of the six scales we could not found data on reliability for the systems M.M.�Vinokourov and T.A.�Rockall scale.
When comparing the reliability of the rest of the prognostic systems revealed differences of indicators in all these cases. Author�s�sensitivity and specificity of the calculated scales exceed our data by 11.6% to 31.3%.
Discussion
In Western countries for re-bleeding prognosis using T.A. Rockall scale (1996).�According to this scale, at high risk of recurrence and mortality include patients who have scored 6 or more points�[16,22].
According to scales�I.�C. Chen[30,31] and T.�A.�Rockall�allows to predict the duration of hospital stay and plan accordingly discharge date.�The disadvantages of the scoring system T.A. Rockall some foreign authors attributed the need for endoscopic gastroduodenoscopy (EGD) before counting points�[30,32,33], but the validity of the use of endoscopy as a pivotal trial for the diagnosis and treatment of gastroduodenal bleeding, at the moment there is no doubt [34,35,36]. L.Camellini   believes that the scale of T.A.�Rockall is effective to identify the group of patients with a low risk of re-bleeding [30].
A.�Blatchford based on non-endoscopic evidence developed and tested a simple system to identify patients at high risk of death and recurrent bleeding, in which 6 points and above reaches up to 50% [37].�The authors emphasize that this system can be used immediately upon receipt of the patient prior to the endoscopy method for further treatment strategy.
System�A.�Blatchford, as well as all computer and tabular algorithms inherent hyper prognosis, as evidenced by the high sensitivity of the indicators (99%) together with lower rates of specificity (32%).�Probably, this assessment created based on local conditions diagnostic algorithm and treatment system, as in patients with a low risk of death and recurrence conducting endoscopy bleeding and hospitalization are not provided [38].�The big question is the lack of data and system endoscopy (positioned by the authors as an achievement).�Some authors [Chen�I.C. 2007] pointed out that the scale�O.�Blatchford has a higher sensitivity than the�T.A.�Rockall.�However, the system�O.�Blatchford, and�T.A. Rockall�are not able to clearly identify the group of patients who need surgery [39].
Thus, we see that some scales are simple and are based on a small number of characters [7], others are built on complex mathematical calculations [25], one focuses on the identification of group of patients with a low risk of recurrence of gastroduodenal bleeding [22;�23, 25], others - to identify the group of patients with a high risk of hemorrhage recurrence [7,15,24].
Our results show that none of the scales studied shows high optimum values (reliability, specificity and sensitivity), accuracy and predictive assessment of the likelihood ratio.
The discrepancy in the figures on the basis of the reliability of the authors and of the clinical material in our study may confirm the assumption that each prognosis technique can only be applied in the hospital, where it was created.�However, to confirm this assumption, it is necessary to carry out similar studies on our scales compared to the clinical material other medical institutions.
Probably in the near future we will not be able to create a completely accurate universal prognosis system; first�of all, because the laws of mathematics cannot be applied to the prediction of living biological system, as almost all the components of their values   are variable.
To successfully predict the scale required, high specificity index, accuracy, and at the same time a significant sensitivity and�the PV�-.�To a large extent, from the systems we studied, these requirements correspond to SPRB.
Conclusions
1. None of the six studied relapse prediction systems gastroduodenal ulcer bleeding has all optimally high levels of reliability, which is probably due to the impossibility of applying the laws of mathematics to a complex biological system of the human body.
2. When choosing a treatment strategy in patients with gastroduodenal ulcer bleeding should focus on prognosis system that determines patients at high risk of re-bleeding.�System of prognosis of re-bleeding (SPRB), developed in the clinic of Surgery of the Russian Peoples' Friendship University, is effective in identifying the group of patients with a high risk of re-bleeding.
�
�
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Conflict of Interest: The authors declare that they have no conflict of interest.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and / or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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