Clinico-demographic Profile of the Patient With Pancreaticobiliary Malignancy Undergoing ERCP in a Tertiary Care Center of Nepal: A Cross-sectional Study
Conditions: Cholangiocarcinoma, Bile Duct Carcinoma, Endoscopic Retrograde Cholangio-Pancreatography, Pancreatic Neoplasms
Sponsor: Kathmandu University School of Medical Sciences

 
 
 

 
1 KUSMS – IRC, 2023 
 
A. Research Proposal Information 
 
A.1 Title of the study: 
Clinico-demographic profile of the patient with cholangiocarcinoma undergoing ERCP in 
Dhulikhel Hospital. 
 
 
A.4 List name, affiliation and contact details of all investigator 
A4.1 Faculty or Staff or other  
 
Name 
Position 
Contact address 
E-mail address 
Dr Ram Bdr. Gurung 
Principal 
Investigator 
Dhulikhel Hospital, 
Endoscopy 
department 
rambgurung7@gmail.com 
Dr Pasand Sharma 
Co-investigator 
Dhulikhel Hospital, 
Endoscopy 
department 
pasanda@gmail.com 
Dr Prakash Sapkota 
Co-investigator 
Dhulikhel Hospital, 
Endoscopy 
department 
drprakash@kusms.edu.np 
 
 
 
 
 
A4.2 Students 
Name 
Position 
Contact address 
E-mail address 
Shreesuna Katila 
Co-investigator 
Kathmandu University 
School of Medical 
Sciences, Dhulikhel, Nepal 
shreesuna95@gmail.com 
Samyog 
Adhikari 
Co-investigator 
Kathmandu University 
School of Medical 
Sciences, Dhulikhel, Nepal 
adhikarisamyog90@gmail.co
m 
 
A.5 Contact detail 
Dr Ram Bdr Gurung, Head of the Department, Internal Medicine, Dhulikhel Hospital, 
Dhulikhel,6, Kavre. 
Email address: ramgurung7@gmail.com 
 

 
2 KUSMS – IRC, 2023 
 
A.6 Nature of Study 
□ Clinical trial phase…/ Intervention study  
□ Bioequivalence/ pharmacokinetic drug study 
□ Epidemiological research 
□ Laboratory study 
□ Social/ behavioral research 
□ Study using stored specimens/tissue 
☒ Study using stored medical records 
□ Others…………………………………………………… 
 
A.7 Is study single center or multicenter 
☒  Single center 
□  Multicenter (within Nepal)  
 Please specify the study sites ……………………………………………........ 
□  Multicenter (International) 
 Please specify the study sites …………………………………........................ 
Note: NHRC Approval is compulsory for Ph. D/ International Study/ International 
Collaboration/ Multicenter & Clinical Trial Study. 
 
 
 
 
 
A.8 Summary of the proposed research protocol (within 200 words) 
Cholangiocarcinoma (CCA) or a bile duct cancer is regarded as the second most frequent 
type of primary liver cancer which is diagnosed in the late decades of life with fatal 
outcomes. Its risk factors include primary sclerosing cholangitis, hepatitis, smoking, 
alcohol, obesity, inflammatory bowel disease, cirrhosis, etc. As it is a fatal disease with 
late diagnosis, knowing the risk factors and its occurrence rate will be helpful to design 
interventions based on the evidence. It is  also important for the early treatment and 
increased survival rate of patients. It is a quantitative observational type of study. The 
objective of this study is to collect the clinico-demographic profile of the patients with 
cholangiocarcinoma undergoing  Endoscopic Retrograde Cholangiopancreatography 
(ERCP) in Dhulikhel Hospital. Self- structured Questionnaire will be used as a research 
tool for data collection based on literature review. This kind of  research is crucial to widen 
the knowledge in prevention of the morbidity and mortality due to cholangiocarcinoma. 
Dhulikhel Hospital is a pioneer tertiary care center in Nepal for ERCP, where cases are 
from different parts of Nepal and their medical records will be reviewed to generate the 

 
3 KUSMS – IRC, 2023 
 
evidence of the clinico-demographic profile of the patient with cholangiocarcinoma 
undergoing ERCP.  
 
A.9 Source of Funding/Sponsor 
Non Funded 
 
A.11 Declaration of Co-I 
None 
 
 
 
 

 
4 KUSMS – IRC, 2023 
 
B. DETAIL OF THE STUDY 
 
B.1. Background: 
Bile is a complex aqueous secretion that originates from hepatocytes of liver then 
stored and concentrated in gallbladder or is delivered directly to the intestinal lumen 
whose function is to break down fats and help the body to remove excretory 
products.1 Bile duct is a tube which connects gallbladder and liver to the small 
intestine to allows flow of bile into the small intestine.1 Cholangiocarcinoma (CCA) 
is an epithelial cell malignancy of biliary tree that arises from varying locations.2 Of 
three types i.e Extra hepatic, Hilar and Intra hepatic cholangiocarcinoma, Extra 
hepatic is the most common and most treatable form of cholangiocarcinoma.3–5 Risk 
factors include primary sclerosing cholangitis, hepatitis, smoking, alcohol, obesity, 
inflammatory bowel disease, cirrhosis, host genetic polymorphisms,etc.6 
 
Discussing the data of cholangiocarcinoma, these are most common in Southeast and 
East Asia due to the prevalence of parasitic infection in those particular areas as it is 
one of the important causes of cholangiocarcinoma.7 Ophisthorchis Viverrini and 
Clonorchis sinensis are the hepatobiliary flukes mainly associated with CCA in 
Southeast Asia.6. A study done in the United States stated the continued increment in 
incidence of cholangiocarcinoma from 2001-2017 with greater increase in 
intrahepatic CCA than extrahepatic CCA. 8 Different liver flukes are also associated 
with cholangiocarcinoma in countries like Vietnam, Thailand, Korea, China, 
Vietnam, etc.7  
 
Accounting for about 2% of all malignancies, CCA is considered as a rare 
malignancy.9 It rarely occurs before the fourth decade of life with a wide variation of 
incidence rates in different geographical regions that reflect the distribution of risk 
factors, both environmental and genetic.9,10 Hence it is known as the disease with late 
diagnosis and fatal outcome.11 This form of cancer is prevalent in males compared to 
females and it is found to affect people in their fifth to seventh decade of life.11 
According to the American Cancer Society (2023), about 41,420 cases of liver and 
intra hepatic cancer are estimated including both sexes among which 29,380 deaths is 
reckoned.12 CCA is regarded as the second most frequent type of primary liver 
cancer.13 Risk factors related to CCA may vary within different geographical 
variations.14 In case of hepatobiliary cancers, CCA accounts for about 20% of death 
whereas it constitutes 13% of total cancer mortality. 15 As it is not more frequently 
diagnosed worldwide, it is also regarded as an orphan cancer.16  
 
 

 
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The treatment choice of CCA either surgical or radiological, is dependent on different 
factors such as anatomical position, lymph node and vascular invasion, metastatic 
condition, etc. 13,16 In case of chemotherapy, combination of gemcitabine and 
cisplatin has been considered as a standard chemotherapy regimen as the combination 
of both of them has been shown overall survival rate of 3.6 months as compared to 
gemcitabine alone.17 Patients are usually diagnosed at older age and further it is made 
worse by symptoms such as pruritus, jaundice, ascites, etc.18 There has been limited 
information on the application of autoantibodies (AABs) as biomarkers in case of 
primary liver tumors such as CCA so far.19 However, carbohydrate antigen 19-9 
(CA19-9) and carcinoembryonic antigen (CEA) were the most commonly studied 
biomarkers.19      
 
B.2. Statement of the problem/ rationale/ need of the study: 
Studies have shown that the death rate from Cancer is increasing globally, especially in 
low and middle income countries.19,20 Incidence of CCA is increasing in western 
countries during the last decades and increasing tremendously in Asian countries as well. 
10,19,20 The number of CCA raised from 1720 in 2010 to 2161 in 2013 in England.21 The 
highest incidence of CCA has been reported in northeast Thailand.22 
                                                                                                                                                                             
Nepal being an Asian country is also in the region to have increased cases of 
cholangiocarcinoma and need rigorous scientific studies to generate evidence to prepare 
interventions on its prevention and treatment. Cholangiocarcinoma being the major 
contributing factor for the death of the humans, this needs early diagnosis and treatment 
system to intrude the increasing mortality and morbidities. Studies should be conducted 
in its risk factors, disease status, occurrence and other factors so that such studies are 
considered to estimate the prevention and management of such deadly diseases.  
 
The studies on this sector is in dearth and is in great need of the involvement of 
academia, medical centers and different institutions. Such studies will provide evidence 
to plan several interventions for its better and efficient prevention and treatment option.  
 
 
B.3. Research hypothesis (if applicable): 
NA 
 
 
 
 
 
 

 
6 KUSMS – IRC, 2023 
 
B.4. Objectives of the research: 
 General objective (s) 
The aim of the study is to assess  the clinico-demographic profile of the patient with 
cholangio-carcinoma undergoing ERCP in Dhulikhel Hospital. 
 
Specific objective(s): 
This study holds the objective, 
● To identify clinical profile of the patient with cholangio-carcinoma undergoing 
ERCP 
● To describe the demographic profile of the patient with cholangio-carcinoma 
undergoing ERCP  
● To measure the outcome of ERCP procedure in them. 
● To  identify the association between demographic variable and clinical 
presentation of the patient with cholangio-carcinoma undergoing ERCP 
 
 
B.5. Study site and justification:  
The study will be conducted in the Endoscopy unit of the Internal medicine department  
of Dhulikhel Hospital. This hospital has provided services to more than 50 out of 75 
districts of the country. It provides services to about 2.7 million people from 
Kavrepalanchowk, Sindhupalchowk, Dolakha, Lalitpur, Kathmandu, Sindhuli, 
Ramechhap and other surrounding districts per-year. In Nepal ERCP procedure has been 
limited to very few Tertiary centers and Dhulikhel Hospital is the pioneer institute to 
provide the ERCP procedure (since 2011) in the nation. This procedure is mainly 
performed for the indication of choledocolithiasis, obstructive Jaundice, acute biliary 
pancreatitis, cholangiocarcinoma, etc. In 2019 only, a total of 1352 patients had 
undergone ERCP in Dhulikhel Hospital as per the monthly ERCP report book obtained 
from the Department of Endoscopy of Dhulikhel Hospital.  
 
B6. METHODS/ METHODOLOGY: 
B.6.1 Research Methods (Cross in the appropriate box) 
 a) Qualitative Research 
  ☐ 
Quantitative Research ☒ 
c) Mixed Research  ☐ 
 
B.6.2. Study design: 
This is a quantitative, retrospective, descriptive cross-sectional observational study.. The 
outcome and the exposure will be measured at the same time as a snapshot.  
 
B.6.3. Study Variables 
The study variables will be the socio-demographic variables and the clinical details of the 
study participants.  

 
7 KUSMS – IRC, 2023 
 
 
B.6.4. Expected outcomes of the research  
The expected outcome of the research is to present a clinical finding of this under studied 
clinical area in Nepal. Furthermore, this will be a reference for the future researchers to 
conduct further studies on this sector to enhance the prevention, management and the 
treatment services.  
 
B.7 STUDY POPULATION AND SAMPLE 
B.7.1. Participants/ study population: 
Patients with cholangiocarcinoma who had undergone ERCP in Endoscopic Department 
of Dhulikhel Hospital. The patient's information will be obtained from patients' medical 
records from the outpatient and inpatient department of Dhulikhel Hospital. Thus, the 
person will not be contacted directly for the data collection. 
 
B.7.2  Selection criteria:  
 Inclusion criteria: 
● All the participants with cholangiocarcinoma had undergone ERCP 
● above 18 years of age. 
 
Exclusion criteria: 
● ERCP failed cases 
 
B.7.3.  Sampling method/ technique: 
We will do purposive sampling from the eligible list obtained from the medical records.  
 
 
 
 
 
 
 
B.7.4. Sampling Unit: 
The sampling unit is the patient with cholangiocarcinoma who had undergone ERCP.  
 
 
 
B.7.5  Sample size determination: 
All the eligible cases listed in the medical record of Dhulikhel Hospital from January 
2017 to January 2023. Hospital records showed approximately 75 cases of 
cholangiocarcinoma per year. So, we will conduct a total population sampling with an 
estimated sample size of  375.  
 
 
 

 
8 KUSMS – IRC, 2023 
 
B.8. Procedure: 
First of all, the researcher will get formal approval for data collection in the institution. 
 
● After ethical clearance, data will be collected through a case sheet of the patient 
and record of ERCP procedure at the department using prepared Per forma.  
● Data of procedure outcome will be collected via call to the patient. Before 
collecting information from the respondent, they will be informed about the 
objective of the study and will be assured of privacy and volunteering participation. 
 
B.8.1. Data Collection Tools/ Measures: 
● Clinical Proforma will be used to collect data  
Part I: Socio-Demographic information of patient 
Part II: Information related to Clinical profile of patient 
Part III: outcome of ERCP procedure 
● The data will then be entered into Microsoft Excel for further data management.  
 
B.8.2. Pretesting 
The proforma will be pretested entering about 10 cases so that we can further modify the 
proforma.  
 
B.8.3. Validity and Reliability of tool 
The tool will be the proforma and this will be based on other literatures and as per the 
experts suggestion. Indeed, the principal investigator is the physician (expert) to perform 
this procedure in Nepal and other team members have some kind of exposure in this 
sector.  
 
B.9. Plan for specimen/data management: 
(a) Data Processing 
● Collected data will be stored in a file to prevent loss or damage. 
● Data will be coded and entered in Microsoft Excel Sheet and will be transferred 
to the Statistical Program for Social  Science (SPSS) for further analysis. 
 
(b) Presentation of Data 
● Data will be categorized on the basis of research objectives. 
● The study will present the descriptive statistics and other details of the variables. 
 
 
 
 
B.10. Plan for data analysis: 

 
9 KUSMS – IRC, 2023 
 
B.10. a. SPSS (Statistical Program for Social  Science)  version  25.0  will  be used  for  
descriptive  as  well  as  inferential statistics. 
B.10. b. Statistical tests: Descriptive statistics (mean, frequency, standard deviation and 
percentage) will be applied. For inferential statistics, Chi-square test will be used for the 
analysis of the categorical data while, t-test or correlation will be done for the continuous 
variables.  
 
B.11. Potential Biases: 
There may be some confounders that will direct to the bias of the study. The information 
in the confounders will be collected and if required will be adjusted in the data analysis.  
 
B.12. Limitations of the study: 
● This is not a common disease, so the sample size of the eligible participants is 
limited. 
● The retrospective study nature of this study may not allow us to incorporate as 
much information as we are seeking. However, future research may address these 
issues.  
 
B.13. Plan for supervision and monitoring: 
● Data will be collected by the co-authors 
● Supervision and monitoring will be done by Principal Investigator and the 
research team 
 
B.14. Plan for dissemination of the research: 
The research will be disseminated to: 
● Conferences  
● Publication in one of the index peer review journal  
 
B.15. DATA AND SPECIMEN BANKING AND/OR SHARING 
B15.1 Management of specimen/data archiving or left-over 
     NA 
B15.2 Specimen/data sharing plan 
 
NA 
 
 
 
 
 
 

 
10 KUSMS – IRC, 2023 
 
C. ETHICAL CONSIDERATION 
10.1. Ethical issues 
Yes/ No 
Justification if yes 
a. Are human participants 
included in the study? 
Yes 
The   study   aims   to   determine   
the clinico-demographic profile of 
the patients with cholangiocarcinoma 
undergoing ERCP in Dhulikhel 
Hospital. But we will not have face to 
face interaction, as all the 
information will be obtained from the 
medical records.  
b. Are vulnerable members 
of the population required 
for this research? (includes 
age under 18, pregnant 
women etc) 
No 
 
c. Are there any risks 
involved for the 
participants? If yes, 
identify clearly what are 
the expected risks for the 
human participants in the 
research and provide a 
justification for these risks. 
No 
 
d. Are there any benefits 
involved for the 
participants? If yes, 
identify clearly what are 
the expected benefits for 
the participants. 
No 
 
 
C1. SIGNIFICANCE OF THE STUDY 
● The study can reveal some risk factors associated with the particular disease 
i.e Cholangiocarcinoma. Thus, it can be regarded as a baseline study for 
conducting any intervention. 
● It can also be used as a reference for future study purposes in similar types of 
study. 
 
 
 
 

 
11 KUSMS – IRC, 2023 
 
C2. BALANCE OF RISK AND BENEFIT  
 
C2.1 Risk of the study and Preventive and alleviative measures for risk 
  
C2.1. Risk management:        
 
Potential risks identified 
Proposed measures to mitigate risks 
1. No direct risk/harm to the study 
participants as medical records will be 
reviewed primarily for patient data 
collection. 
NA 
2.  Information on the patient's current status 
will be gathered via telephone interview 
(only for the feasible cases) where they 
may have to spare a few minutes for the 
data, however, this will take only a few 
minutes. 
Verbal consent will be taken and all the 
information will be provided to the 
participants if the interaction is required.  
 
C2.3 Benefits of the study 
 
The study will be helpful to the future researcher to base on this and plan further studies 
so that we can enhance the prevention and treatment processes.  
 
C3. CONSIDERATION FOR VULNERABLE RESEARCH PARTICIPANTS 
Check whether your study involves any of the following vulnerable research participants.  
☐ Prisoners 
☐ Pregnant women 
☐ Mentally ill persons 
☒ Cancer or terminally ill patients 
☐ Neonates/infants/children (aged <18) 
☐ HIV/AIDS patients  
☐ Institutionalized persons e.g. military, students, etc. 
□   Others (please specify)………………………………….…. 
The study participants are cancer patients, but we will not directly interact with them, this 
study will only review the medical records from the past years.  
 

 
12 KUSMS – IRC, 2023 
 
 
 
 
 
C4. OBTAINING THE CONSENT: 
It is a retrospective study, while collecting information by making a call to the 
participants, verbal consent will be obtained. 
 
 
C4. a. How will the informed consent be obtained from the research participants? 
Only verbal consent will be taken by phone and that will be to follow up the few things 
that will ensure the status of the patients.  
 
 
 
C4.b. Who will obtain the consent from the study participants? 
● Co-authors will obtain verbal consent on the telephone.  
 
 
C4. c. Is there anything being withheld from the research participants at the time the 
informed consent is being sought? Mention “YES” or “NO 
 
 
NO 
 
 
C4.d Compensation for research participants 
☐ Yes, please provide details: 
………………………………………………..……… 
 
☒ No, please provide reasons: This is a retrospective study and the data will be 
obtained from medical records and ERCP procedure of the patients.  
 
 
 
 
 
 
 
 
 
 
 
 

 
13 KUSMS – IRC, 2023 
 
 
 
 
 
D. APPENDIX 
D.1 REFERENCES  
 
1. Boyer JL. Bile formation and secretion. Compr Physiol. 2013 Jul;3(3):1035–
1078. 
2. Razumilava N, Gores GJ. Cholangiocarcinoma. Lancet. 2014 Jun 
21;383(9935):2168–2179. 
3. Rizvi S, Gores GJ. Pathogenesis, diagnosis, and management of 
cholangiocarcinoma. Gastroenterology. 2013 Dec;145(6):1215–1229. 
4. DeOliveira ML, Cunningham SC, Cameron JL, Kamangar F, Winter JM, 
Lillemoe KD, et al. Cholangiocarcinoma: thirty-one-year experience with 564 
patients at a single institution. Ann Surg. 2007 May;245(5):755–762. 
5. Nakeeb A, Pitt HA, Sohn TA, Coleman J, Abrams RA, Piantadosi S, et al. 
Cholangiocarcinoma. A spectrum of intrahepatic, perihilar, and distal tumors. Ann 
Surg. 1996 Oct;224(4):463–73; discussion 473–475. 
6. Tyson GL, El-Serag HB. Risk factors for cholangiocarcinoma. Hepatology. 2011 
Jul;54(1):173–184. 
7. Zheng S, Zhu Y, Zhao Z, Wu Z, Okanurak K, Lv Z. Liver fluke infection and 
cholangiocarcinoma: a review. Parasitol Res. 2017 Jan;116(1):11–19. 
8. Javle M, Lee S, Azad NS, Borad MJ, Kate Kelley R, Sivaraman S, et al. 
Temporal Changes in Cholangiocarcinoma Incidence and Mortality in the United 
States from 2001 to 2017. Oncologist. 2022 Oct 1;27(10):874–883. 
9. Khan AS, Dageforde LA. Cholangiocarcinoma. Surg Clin North Am. 2019 
Apr;99(2):315–335. 
10. Bergquist A, von Seth E. Epidemiology of cholangiocarcinoma. Best Pract Res 
Clin Gastroenterol. 2015 Apr;29(2):221–232. 
11. Rustagi T, Dasanu CA. Risk factors for gallbladder cancer and 
cholangiocarcinoma: similarities, differences and updates. J Gastrointest Cancer. 
2012 Jun;43(2):137–147. 
12. Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J 
Clin. 2023 Jan;73(1):17–48. 

 
14 KUSMS – IRC, 2023 
 
13. Khan SA, Davidson BR, Goldin RD, Heaton N, Karani J, Pereira SP, et al. 
Guidelines for the diagnosis and treatment of cholangiocarcinoma: an update. Gut. 
2012 Dec;61(12):1657–1669. 
 
14. Global Burden of Disease Cancer Collaboration, Fitzmaurice C, Dicker D, Pain 
A, Hamavid H, Moradi-Lakeh M, et al. The Global Burden of Cancer 2013. JAMA 
Oncol. 2015 Jul;1(4):505–527. 
15. Kirstein MM, Vogel A. Epidemiology and Risk Factors of Cholangiocarcinoma. 
Visc Med. 2016 Dec;32(6):395–400. 
16. Abou-Alfa GK, Andersen JB, Chapman W, Choti M, Forbes SJ, Gores GJ, et al. 
Advances in cholangiocarcinoma research: report from the third 
Cholangiocarcinoma Foundation Annual Conference. J Gastrointest Oncol. 2016 
Dec;7(6):819–827. 
17. Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, et al. 
Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J 
Med. 2010 Apr 8;362(14):1273–1281. 
18. Kandel B, Singh Y. P-144 clinical features and outcome of advanced 
cholangiocarcinoma. Ann Oncol. 2015 Jun;26(suppl 4):iv41. 
19. Tshering G, Dorji PW, Chaijaroenkul W, Na-Bangchang K. Biomarkers for the 
Diagnosis of Cholangiocarcinoma: A Systematic Review. Am J Trop Med Hyg. 
2018 Jun;98(6):1788–1797. 
20. Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. A 
comparative risk assessment of burden of disease and injury attributable to 67 risk 
factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for 
the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2224–
2260. 
21. Alsaleh M, Leftley Z, Barbera TA, Sithithaworn P, Khuntikeo N, Loilome W, et 
al. Cholangiocarcinoma: a guide for the nonspecialist. Int J Gen Med. 2019;12:13–
23. 
22. Bridgewater J, Galle PR, Khan SA, Llovet JM, Park JW, Patel T, et al. 
Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma. J 
Hepatol. 2014 Jun 1;60(6):1268–1289. 
 
 
 
 

 
15 KUSMS – IRC, 2023 
 
D.2.Consent form: 
                                             
Title of the study: Clinico-demographic profile of the patient with Cholangiocarcinoma 
undergoing ERCP in Dhulikhel Hospital 
 
Introduction and consent: 
I am Doctor Ram Bahadur Gurung, Associate professor of Kathmandu University School 
of Medical Sciences, Dhulikhel Hospital. I am conducting research on “Clinico 
Demographic profile of the patient with cholangiocarcinoma undergoing ERCP in 
Dhulikhel Hospital ”. I ascertain you that the information you provide will be 
confidential and used for the study purpose only. Participation in this study is completely 
voluntary. You may withdraw at any time from this study without giving any reason. 
Any queries, misunderstanding can be dealt with by the researcher. 
If you are willing to be a participant of this research, please put a tick below: 
I agree                                                I disagree 
 
 
Date of collection: 
Name of researcher: 
Sign of researcher:  
Date:  
Serial no.: 
 
Direction: Please give the correct answer to the questions. I ensure that the information 
given would be used for study purposes only and will be kept confidential. I will be 
thankful for your kind cooperation. 
 
Address……… 
 
      
 
 
 
 
 
 
 
 
 
 

 
16 KUSMS – IRC, 2023 
 
English Questionnaire  
 
PART 1: SOCIO-DEMOGRAPHIC CHARACTERISTICS 
 
1. Age (in completed years)………..     
 
2. Gender:  
 
 
    Male                   Female       Others (specify)............. 
 
3. Ethnicity 
a. Brahimin/chhetri 
b. Newar 
c. Mongolian 
d. Dalit 
e. Terai region 
f.  
4. Occupation 
a. Agriculture 
b. Service 
c. Labor 
d. House maker 
e. Student 
 
5. Food habit 
a. Vegetarian 
b. Non-Vegetarian 
 
6. Smoking Habit 
a. Yes 
b. No 
7. Alcohol Intake 
a. Non-alcoholic 
b. Moderate 
c. Significant 
 
 
 
 
 
 
 

 
17 KUSMS – IRC, 2023 
 
Part 2: Information related to Clinical profile of the patient 
 
1. Mode of presentation 
a. Cholangitis 
      b. Obstructive Jaundice 
    
      c. Non-icteric Cholestasis 
 
2.  Comorbidity 
a. Yes 
b. No 
 
3.  Symptoms 
a. Itching 
b. Abdominal Pain 
c. Asymptomatic Jaundice 
d. Anorexia 
e. Weight loss 
4.  Investigations 
a. USG 
b. CT Scan 
c. MRI 
d. MRCP 
e. EUS 
5. EUS FNA 
          a) Yes                                          b)No 
 
6. If Yes                                                         
1) Positive 
2) Negative     
 
7.  Brush cytology                                               
                      a) Yes                                                                b) No 
 
8.  If Yes 
           1) Positive 
           2) Negative                                                                
          

 
18 KUSMS – IRC, 2023 
 
9.  Intra ductal biopsy 
                         a) Yes                                                           b) No 
 
10.    If Yes 
                1) Positive 
                 2) Negative  
 
11. Surgical operability 
a. Operable 
b. Non-operable 
c. Unknown 
 
12.  Lab reports 
a) Total bilirubin………… 
b) Direct bilirubin………. 
c) ALP……… 
d) GGT……… 
e) AST……… 
f) ALT……… 
g) PT……….. 
h) INR……… 
 
13. Type of growth 
a. Distal  
b. Hilar 
1) Bismuth-I 
2) Bismuth-II 
3) Bismuth-III 
4) Bismuth-IV 
5) Bismuth-V 
 
 
 
 
 
 
 
 
 
 

 
19 KUSMS – IRC, 2023 
 
 
Part 3. Outcome of ERCP procedure  
 
14. Type of stent used in ERCP:  
a) Plastic stent 
b) Metal stent (SEMS) 
 
15. Outcome of Stenting 
a) Immediate 
b) Failed Stenting 
c) Successful stenting 
 
16.  Complications  
a) Perforation 
b) Bleeding 
c) PEP 
d) PEC 
 
17. If PEP done 
               1) Within 2 weeks 
               2) After 2 weeks 
 
18. If PEC  done                                                   
1) Within 2 weeks 
2) After 2 weeks 
                                      
19. Restenting 
a) Yes                                                            b) No 
1) Within 1 month 
2) Within 2 month 
3) Within 3 month 
20. Radio- Frequency Ablation 
⮚ Yes 
⮚ No 
21. Survival Rate 
a) < 1 month  
 
 
           c) 6 month- 1 year 
b) 3-6 month  
 
 
           d) >1 year