Comparison of Success Rate and Complication Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis in Cirrhotic Patients With Ascites
Phase: NA
Conditions: Ascites Hepatic
Sponsor: Sang Gyune Kim

 
 
Research Plan 
 
A Study on the Comparison of Success Rate and 
Side Effects of the Conventional Method and the 
Method Using a New Fixation Device in Performing 
Ascites Puncture in Cirrhotic Patients with Ascites 
 
Comparison of success rate and complication between conventional versus new anchoring 
device using paracentesis for cirrhotic patients with ascites 
 
 
 Ver. 1.0 _ 20210621 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Department of gastroenterology, Soonchunhyang University Bucheon 
Hospital   
Sang Gyune Kim

 
1. Title of the research 
(Korean) 복수를 가진 간경변증 환자들에서 복수천자 시행 시 고식적인 방법과 새로운 
고정장치를 사용한 방법의 성공률 및 부작용 비교에 관한 연구 
(English) Comparison of success rate and complication between conventional versus new 
anchoring device using paracentesis for cirrhotic patients with ascites 
 
2. Name and address of the institution  
1) Name of the institution : Soonchunhyang university Bucheon hospital 
                  Jomaru-ro 170 Wonmi-gu Bucheon-si Gyeng-gi-do 
2) Support institution: ㈜다림양행 
3) Participating institusion 
 
Institution 
Research director 
1 
Inje University Haeundae 
Paik Hospital 
허내윤 
2 
Korea 
University 
Anam 
Hospital 
서연석 
 
3. Chief researcher and collaborator (Affiliation/Name/Title) 
Chief researcher : 
Department of gastroenterology, Soonchunhyang University Bucheon, Kim Sang Gyune M.D. Ph.D. 
Collaborator:  
Department of gastroenterology, Soonchunhyang University Bucheon, Kim Yeong Seok M.D. Ph.D. 
Department of gastroenterology, Soonchunhyang University Bucheon, Yoo Jeong Ju M.D. Ph.D. 
Department of gastroenterology, Soonchunhyang University Bucheon, Jeon So Hyun M.D. 
Research Officer : Department of gastroenterology, Soonchunhyang University Bucheon, Noh Ji 
Eun R.N. 
 
4. Research Background 
When cirrhosis occurs due to various causes, such as chronic hepatitis B and alcohol, intestinal 
vasodilation occurs due to portal hypertension and effective plasma volume decreases.1 Ascites is 
a major complication of cirrhosis and occurs in 50% of cirrhosis patients after 10 years of follow-
up.2 At this time, ascites that is not controlled despite a low-salt diet of 40 mmol/day and high-
dose diuretic treatment (spironolactone 400 mg/day + furosemide 160 mg/day) is defined as 

refractory ascites, and diuretic-resistant ascites and diuretics Diuretic-intractable ascites can be 
divided into two types.2,3 
There are clinical studies showing that albumin administration and repeated therapeutic ascites 
puncture are relatively safe and effective in cirrhosis patients with large amounts of ascites or 
refractory ascites.4,5,6 In cirrhosis patients with refractory ascites, puncture is usually performed 
using an 18G angiocatheter. However, with conventional methods, the catheter is pulled out 
during ascites drainage and re-puncture is frequently performed. In many cases, the continuation 
of the catheter is unstable because it is fixed using tape and gauze without a special fixing device. 
The carahox set is a medical device created to compensate for the instability of maintaining the 
catheter. This study aims to suggest a convenient and safe therapeutic ascites method for patients 
with refractory ascites cirrhosis by comparing the success rate, re-puncture rate and complications 
of ascites puncture using a traditional method and a new fixation device. 
 
5. Research Hypothesis 
In patients with refractory ascites, the ascites puncture method with a new fixation device will 
have a higher success rate than the existing vascular catheter puncture method. 
 
6. Research Objective 
1) Primary Purpose 
Comparison of success rates of ascites puncture between palliative ascites and kara-hoc in 
patients with cirrhosis with refractory ascites2) 이차 목적 
a. Surgical complications 
b. Patient satisfaction 
c. Operator satisfaction 
d. Factor of successful puncture 
e. Number of re-puncture 
 
7. Research Population  
7-1. Target Disease 
Liver cirrhosis with ascites 
 
7-2. Inclusion Criteria) 
 If all of the conditions below are met 
1) Adult men and women over the age of 19 

2) Patient with pathological or clinical diagnosis of cirrhosis 
3) Patients with Grade 2 or higher ascites as a complication due to portal hypertension 
4) Patients who are symptomatic and need regular ascites puncture  
5) Patients consenting to this study 
 
7-3. Exclusion Criteria 
If any of the following conditions apply 
1) Patients with ascites due to peritoneal metastasis due to malignant tumor 
2) Patients with high bleeding risk (PT INR>3, PLT<30,000/mm3) difficult to perform ascites 
3) Hepatic encephalopathy or hepatic nephrotic syndrome 
4) Severe cardiovascular disease, lung disease, or DIC 
5) Paracentesis refusal  
6) Patients with ascites control possible with diuretics  
7) Pregnancy 
  
7-4. Target number of cases and calculation basis 
In a preliminary study conducted on 20 cirrhotic subjects, 12 cases of successful puncture for 
ascistes using both Kara-hoc and conventional method were performed, 5 cases of success only 
with Kara-hoc, and only 1 case of success with conventional method, with a difference of 20%, 
and a total of 61 cases were required, and 80 cases were required when the drop-out rate of 30% 
was taken into account. 
McNemar Test Analysis 
Numeric Results for Two-Sided Test 
 
Power 
N 
P10 
P01 
Difference 
(P10-P01) 
Proportion 
Discordant 
Odds  
Ratio 
Alpha 
Beta 
0.80516 
61 
0.250 
0.050 
0.200 
0.300 
5.000 
0.050 
0.19484 
 
 
 
 
References 
Schork, M. and Williams, G. 1980. 'Number of Observations Required for the Comparison of Two 
Correlated  Proportions.' Communications in Statistics-Simula. Computa., B9(4), 349-357. 
Machin, D., Campbell, M., Fayers, P., and Pinol, A. 1997. Sample Size Tables for Clinical Studies, 2nd    
Edition. Blackwell Science. Malden, MA. 
 
7-5. Research Subject Recruitment Plan 

Registered patients are recruited for patients with cirrhosis who require therapeutic ascites 
puncture due to intractable ascites among patients with cirrhosis who have visited the 
gastroenterology department outpatient department, ward, and emergency room. 
 
7-6 . Additional protection measures in case of inclusion of vulnerable research 
subjects 
Vulnerable subjects, such as children, pregnant women, and patients with hepatic encephalopathy, 
who are likely to have difficulty obtaining informed consent due to cognitive decline, were 
excluded from the study. 
 
8. Expected study period 
From IRB approval date to December 31, 2022 
 
9. Research method (including observation/inspection items) 
This study is a multi-center, prospective, interventional study, in which subjects who meet the 
selection criteria are enrolled at each institution during the study period from the date of research 
approval. The diagnosis of liver cirrhosis of the subject is made when there is a clear liver surface 
nodule in the performed imaging test and the liver biopsy is F4 or the liver elasticity 
measurement method is 11 kPa or more. is based on Subjects should perform multiple puncture 
at least twice during the outpatient or hospitalization period, and perform Karahoc puncture and 
vascular catheter puncture once each, and the order is set at random. The standard for successful 
ascites puncture is set as 3L or more of drainage when performing one puncture, and re-puncture 
is judged when ascites does not drain from the beginning after catheter insertion or when it is 
drained to less than 1L due to lumen obstruction or catheter dislocation. do. HR and BP 
measurements (immediately before and after multiple puncture and drainage are completed) 
before and after ascites are performed to compare the incidence of complications that may occur 
in each of the multiple puncture methods. 
 
1) Primary evaluation item: success of multiple puncture 
2) Secondary evaluation items: Occurrence of surgical complications, patient satisfaction, operator 
satisfaction, number of re-punctures 
 
 

 
 
 
 
 
 
 
 
 
 
 
[Figure 1] Study flow chart 
 
 
 
10. Evaluation Criteria and Evaluation Method 
 
Multiple puncture success : Drainage of 3L or more per puncture 
 
Complications : Bleeding, hematoma, intestinal perforation, hypotension, etc. 
 
Patients satisfaction : Assessment with Visual Analogue Scale 

 
Operator satisfaction : Assessment with Visual Analogue Scale 
 
Re-puncture : When ascites does not drain from the beginning after catheter insertion, or 
when it drains less than 1 L due to lumen obstruction or catheter dislocation and requires re-
puncture 
 
11. Differences from conventional treatment and this study (standard treatment 
guideline description of the target disease) 
 Patients with intractable ascites who have severe abdominal distension and dyspnea are referred 
to in the medical guidelines to perform a mass ascites puncture. Ascites puncture using the Kara-
hoc set is also different in that it uses an improved puncture device with an abdominal wall 
fixation device according to the general indications for mass ascites puncture. 
 
12. Result Variable 
Whether the plural puncture was successful  
 
13. Safety Assessment 
Measure the pulse rate and blood pressure before and after multiple puncture, and check the 
properties of the liquid drained immediately after puncture to check for bleeding or intestinal 
perforation.  
 
14. Data and Statistical Analysis 
Comparison of the success rate of ascites puncture using the conventional method and the 
Karahoc device is a procedure that is repeated once in the same patient, so the influence of other 
confounding variables can be excluded and analyzed using the McNemar test. Multivariate 
analysis is performed using logistic regression for factors involved in treatment success in the 
entire patient group. Patient and operator satisfaction is quantitatively measured using Visual 
Analogue Scale, and then the average value of satisfaction is compared through t-test. 
 
15. Secruing research ethics 
The procedures stipulated in this protocol will ensure that researchers comply with the 
fundamental spirit of the GCP and the Declaration of Helsinki in conducting, evaluating and 
recording the results of this study, and will be implemented in accordance with the KGCP, the Law 
on Bioethics and Safety and related regulations. 

This research protocol and its changes, (subject written consent and ) related to information 
provided to the subject, are submitted to the IRB of the conducting institution to obtain formal 
approval for the conduct of the study in accordance with domestic regulations, and the IRB for 
conducting the study The study will not be conducted prior to receipt of the documentation 
relevant to the decision. 
 
 
 
16. Matters concerning the protection of personal information of research subjects 
In order to protect the information of the research subjects, unnecessary personal identifiers of 
the collected data are removed. In particular, in the case record, the patient's name, resident 
registration number, Chart No. etc. should not be recorded, and the identifier code linked to 
personal information is managed separately. In addition, when presenting research results, make 
sure to present them in a form that cannot confirm the identity of the individual.  
 
17. Research subject information and consent form 
This study is for patients with refractory ascites, and the names of all subjects are kept 
confidential and the subjects are identified during recording and evaluation by the number 
assigned in the study. Inform the study subjects that all research data will be stored on a 
computer and treated in strict confidentiality. The subject consent form that has been signed is 
kept by the research director. By signing this protocol, the principal investigator agrees to obtain 
informed consent from the research subjects participating in the study, and also to receive due 
diligence upon request. 
 
18. 연구자료 관리 및 보관 
Electronic document files will be stored by installing an appropriate firewall and setting a 
password, and the password should be changed periodically. In addition, the person who can 
access the research file should be limited to those who are registered in the research and have 
the right to access. Relevant records should be stored in a secure space with controlled access or 
in a file storage with a lock. The data collected in the clinical trial will be stored for 3 years from 
the study end date and then destroyed, and after the end date, these documents will be 
transferred to a designated place such as a document storage room to prevent damage or loss 
due to accidents. 
 

19. Benefit and risk of study subjects 
Based on this study, we aim to improve patients' symptoms and improve the quality of medical 
care by enabling a more practical and safe method of ascites puncture for patients in need of 
therapeutic ascites. 
 
20. Compensation plan for research subjects (if there is no compensation, the 
relevant reason) 
This study will comply with relevant laws and regulations and strictly conduct clinical trials in 
accordance with related literature, recommendations, and suggestions, and immediate medical 
management will be made for complications that occurred during the course of this study. 
However, since the puncture needle of the Karahox set uses the same formulation as the vascular 
catheter, general complications that may occur during the puncture process will be treated in the 
daily treatment area, so there is no separate compensation provision for this. 
 
21. Confidentiality (including protection of personal information of research 
subjects) and record keeping 
The personal information to be collected is gender, date of birth, height, weight, disease name, 
past medical history, and blood test findings, and sensitive information is not included in the 
personal information to be collected. The purpose of collecting and using the above items is for 
the academic purpose of analyzing all patients to find out what factors cause a significant 
difference during ascites puncture, and it is not used for any other purpose. 
 
 
Clinical trial schedule 
Observation  
and inspection items 
Screening 
Intervention 
Session number 
Session 01) 
Session 11) 
Session 2 
Subject consent 
● 
 
 
Basic information 
● 
 
 
Physical Exam/Vital Signs 
● 
● 
● 
Laboratory test 7) 
 
 
 
Hematology test 
● 
● 
● 
Blood coagulation test 
● 
● 
● 

Serum biochemical test 
● 
● 
● 
Radiologic examination 
● 
 
 
Inclusion/Exclusion 
criteria 
● 
 
 
Randomization2) 
 
● 
 
Therapeutic 
ascites 
puncture 
 
● 
● 
Confirmation of puncture 
success 
 
● 
● 
Confirmation of stability 
(adverse reaction) 
 
● 
● 
1) Session 0 and session1 can be identical 
2) Randomization is performed if the selection/exclusion criteria are met after confirming the 
screening test results. If randomization is a kara-hoc set, session 1 uses a kara-hoc set, session 
2 uses a vascular catheter, and if randomization is a vascular catheter, session 1 uses a 
vascular catheter and seesion 2 uses a kara-hoc set. 
 

 
22. References 
1. Iwakiri Y Pathophysiology of portal hypertension. Clin Liver Dis. 2014;18:281-291 
2. Moore KP, Aithal GP. Guidelines on the management of ascites in cirrhosis. Gut. 2006 Oct; 
55(Suppl 6): vi1–vi12. 
3. Gentilini P, Laffi G, La Villa G, Romanelli RG, et al. Albumin improves the response to diuretics in 
patients with cirrhosis and ascites: results of a randomized, controlled trial. J Hepatol 
1999;31:1088-1097 
4. Gines P, Arroyo V, Quintero E.et al Comparison of paracentesis and diuretics in the treatment of 
cirrhotics with tense ascites: results of a randomized study. Gastroenterology 1987;93:234–241 
5. Quintero E, Gines P, Arroyo V.et al Paracentesis versus diuretics in the treatment of cirrhotics 
with tense ascites. Lancet 1985;16:611–612 
6. Salerno F, Badalamenti S, Incerti P.et al Repeated paracentesis and i.v. albumin infusion to treat 
‘tense' ascites in cirrhotic patients: a safe alternative therapy, J Hepatol 1987;5;102–108