RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATE & ADDRESS / DR.JAGADEESHA.S.G
POST GRADUATE IN MD GENERAL MEDICINE,
BANGALOREMEDICALCOLLEGE & RESEARCH
INSTITUTE, KR ROAD, FORT, BANGALORE-560002
2 / NAME OF THE INSTITUTION / BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE,KR ROAD, FORT, BANGALORE-560002
3 / COURSE OF STUDY AND SUBJECT / MDIN GENERAL MEDICINE
4 / DATE OF ADMISSION TO THE COURSE / 25.08.2012
5 / TITLE OF TOPIC / “A STUDY OF CORRELATION BETWEEN ESOPHAGEAL VARICES AND PLATELET COUNT/SPLENIC DIAMETER RATIOIN PATIENTS WITH PORTAL HYPERTENSION.”
6. / BRIEF RESUME OF INTENDED WORK:
6.1Need for study:
Esophageal variceal bleeding is one of the most dreaded complicationsof cirrhosis because of its high mortality. The prevalence of varicesin patients with cirrhosis is approximately 60-80% and risk of bleeding is 25-35%.The incidence of esophageal varices increased by nearly 5% per year and the rate of progression from small to large varices approximately 5-10% per year. The mortality rate from variceal bleeding is 20-40%. Recurrent bleeding occurs in 60% of patients within a week.Thus prevention of esophageal variceal bleeding remains at the fore front of long term management of cirrhotic patient.1
In patients with cirrhotic liver disease endoscopic screening for esophageal varicesis currently recommended in all the patients at the time of diagnosis of cirrhosis.As far as patients with no varices at screening endoscopy are concerned,surveillance should be performed every two years on patients with stable liver function and every year on those who show signs of liver function deterioration. Endoscopy should be repeated every year when reveals small varices.
Non invasive assessment of esophageal varices may improve the management of patients with cirrhosis.It will decrease the financial burden and risk of invasive procedure to the patient.In this study use of platelet count and splenic diameter ratio will be helpful in the early diagnosis of esophageal varices and it is cost effective.
6.2ReviewofLiterature:
Esophaegeal varices are a serious consequence of portal hypertension in patients with liver diseases.It is recommended that parameters such as splenomegaly, thrombocytopenia, Childs score, ascites portal flow patterns and platelet count /splenic size ratio are predictors of esophageal varices.
A study conducted by Arulprakash Sarangapani et al Kilpauk medical college Chennai showed that thrombocytopenia large spleen size / platelet spleen diameter ratio strongly predict large number of Esophegeal varices.1
A study conducted by Edoardo.G.Giannini et al showed that the platelet count / splenic diameter ratio may be proposed as a safe and reproducible means to improve the management of cirrhotic patients who should undergo screening endoscopy for esophageal varices.2
Agha.A Anwar.E. et al showed that in patients with cirrhosis platelet count/spleen diameter ratio may be proposed as a non invasive tool for esophageal varices diagnosis, especially in financially deprived developing countries.3
Giannni EG , Botta F, et al showed that the use of platelet count /spleen diameter ratio proved to be an effective means for ruling out the presence of esophageal varices even in the longitudinal follow-upofpatients4.
Grace Marie ALegasto,Judy Sevilla, et al showed that the use of platelet count / splenic diameter ratio showed a good result in discriminating absence and presence of esophageal varices5.
6.3 Objectives of study
1.To develop practice guidelines for the management of gastrointestinal bleeding in adult patients with cirrhosis and portal hypertension.
2.To validate the use of platelet count /splenic diameter ratio for the noninvasive diagnosis of esophageal varices.
MATERIALS AND METHODS:
7.1 Source of data:
Portal hypertension patients admitted in Victoria hospital and Bowring and Lady Curzon hospital attached to BMCRI.
7.2Methods of collection of data:
  1. Study design:Observational study.
  2. Study period: Nov 2012- Oct 2014.
  3. Place of study:VictoriaHospital and Bowring and Lady Curzon hospital attached to BMCRI, Bangalore.
  4. Sample size: 50 patients.
  5. Inclusion Criteria :
1)Newly diagnosed male and female patients in the agegroup 18-75 years withclinical and ultrasonographic evidence of portal hypertension and given informed consent.
F. Exclusion Criteria:
1)Patientswith evidence of hepatocellular carcinoma.
2)Previous or current treatment with beta blockers.
3)Treatments with nitrates and diuretics.
4)Established cases of esophageal varices with portal hypertension on treatment.
G. Methodology:
After obtaining clearance and approval from the Institutional Ethics Committee, 50 patients fulfilling Inclusion/Exclusion criteria who give Informed Consent (Annexure 1) will be included in the study. Data is collected from the case sheets of patients admitted to the ward. Following data will be collected from case sheets of patients in a Study Performa (Annexure 2).
1)Demographic data: Age, sex. Address, IP No, date of admission.
2)Disease data: Diagnosis, duration, co-existing disease, past history of any major illness.
3) Platelet count done by manual method.
4)Ultrasound for the measurement of spleenic enlargement.
5)Complete blood count
6)Liver function test.
7)Renal function test.
8)Upper Gastrointestinal Endoscopy.
H. Statistical analysis:
Results will be analyzed using Descriptive statistics namely mean, standard deviation and percentage wherever applicable.
7.3 Does the study require any investigation to be conducted on patients or animals specify?
Animals-NO
This study does requireinvestigations to be conducted on patients.
7.4Has the ethical clearance been obtained from ethics committee of your Institution in case of 7.3?
Yes.The ethical clearance has been obtained by BMCRI Bangalore
LIST OF REFERENCES:
1)Arulprakash Sarangapani et al. Department of digestive health and disease, Govt.peripheral hospital Kilpak medical college, Chennai.102. India.Volume 16 no1 muharam 1431 AH Jan 2010 The Saudi J of gastroenterology.
2)Giannini E, et al. platelet count spleen diameter ratio: proposal and validation of a non invasive parameter to predict the presence of oesophageal varices in patients with liver cirrhosis. Gut. 2003 – PubMed-NCBI.
3)Adnan agha et al. use of platelet count / spleen diameter ratio for non invasive diagnosis of esophageal varices. The Saudi journal of gastroenterology year 2011, volume 17 , issue 5, page 307-311.
4)Giannini EG Botta F, et al. application of the platelet count / spleen diameter ratio to rule out the presence of esophageal varices Dig Liver dis. 2005 – PubMed- NCBRI.
5) Grace Marie A Legasto, Judy Sevilla,et al platelet count/splenic diameter ratio;A noninvasive parameter to predict the presence of esophageal varices Phil J Gastroenterol 2006;2;33-38.
6)Grace ND Diagnosis and treatment of gastrointestinal bleeding secondary to portal hypertension. American college of Gastroenterology practice parameters committee. Am. J. Gastroenterology. 1997; 92:1081-91.
7)Schepis F Camma C Nicefor D. Which patients with cirrhosis should undergo endoscopic screening for esophageal varices detection. Hepatology. 2001.33: 335-8.
8)Zaman A Becker T Lapidus J Benner K. Risk factors for the presence of varices in cirrhotic patients without history of variceal hemorrhage. Arch intern medicine.2001: 161:2564-70.
9)Harrisonsprinciples of internal medicine 18th edition p 321,2597-2599.
10)API Textbook of medicine 8th edition p 676.
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SIGNATURE OF CANDIDATE
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REMARKS OF THE GUIDE

/ Study of platelet count/ spleenic diameter ratio will go a long way in making the diagnosis of esophageal varices more appropriate effective safe and economical.Hence I strongly recommend this for dissertation.
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NAME AND DESIGNATION
11.1 GUIDE / Dr. JAYACHANDRA.MBBS,MD.
ASST. PROFESSOR, DEPARTMENT OF MEDICINE, BMCRI, BANGALORE.
11.2SIGNATURE

11.3CO-GUIDE (IF ANY)

11.4SIGNATURE

11.5 HEAD OF THE DEPARTMENT
/ Dr.B.PRABHAKAR. MBBS,MD.
PROFESSOR & HEAD, DEPARTMENT OF MEDICINE, BMCRI, BANGALORE.
11.6 SIGNATURE
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12.1 REMARKS OF CHAIRMAN AND PRINCIPAL
12.2 SIGNATURE

Annexure - I

WRITTEN INFORMED CONSENT

I ______age ______sex ______have been explained in a language understood by me about the study entitled ‘A study of correlation between esophageal varices and platelet count and spleenic diameter ratio in patients with portal hypertension’

I have been explained about the procedures and investigations that will be done during study. I have no objection to sharing my medical information and details in case records with the investigators of this study. Personal identity will not be revealed and data may be used for publication / dissertation purpose.

I understand that my participation in this study is entirely voluntary and I am willing to take part in this study

Place: signature:

Date: Name:

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