Comparison of Early Needle-knife Precut Papillotomy Over a Pancreatic Stent and Transpancreatic Sphincterotomy in Difficult Cannulation: A Prospective Randomized Controlled Trial
Phase: NA
Conditions: ERCP Surgery
Sponsor: Chang Gung Memorial Hospital

 
 
ClINICAL RESEARCH: IRB 202101221A3 
Date of Approval: 2021/09/28 
Comparison of Early Needle-knife Precut Papillotomy over a Pancreatic 
Stent and Transpancreatic Sphincterotomy in Difficult Cannulation: A 
Prospective Randomized Controlled Trial 
 
 
Reprint requests and correspondence: 
Fai-Meng Sou 
Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, 123, 
Ta-Pei Road, Niao-Sung Hsiang, Kaohsiung, 833 Taiwan 
Tel.: 886-7-7317123 ext. 8301, Fax: 886-7-7322402 
E-mail: kelsonsou@hotmail.com 
 
 

 
 
Early NK Precut vs TPS in Difficult Cannulation: A RCT (ENKPT Trial) 
Introduction 
Selective bile duct cannulation is often required in therapeutic endoscopic 
retrograde cholangiopancreatography (ERCP). However, 10% to 20% of the bile duct 
remains inaccessible even by experienced endoscopists. [1, 2] 
When standard methods of cannulation have been exhausted, the use of various 
precut techniques has been proposed to increase success rate. Needle-knife precut 
papillotomy (NKPP) is usually employed to facilitate access to the CBD in difficult 
cases. Most studies have identified precut and multiple cannulation attempts as two 
independent procedure- related risk factors for post-ERCP pancreatitis (PEP) [3, 4]. 
Furthermore, theand can significantly reduce the incidence of PEP in a randomized 
trial study [5]. NKPP with a small incision over a pancreatic stent will improve the 
success rate (96.9 % vs. 86.1 %, p = 0.0189)and reduces the complication rate (7.1% 
vs. 33.0 %, p < 0.001 )comparing to standard NKP (without pancreas stent) [6]. 
Transpancreatic sphincterotomy (TPS), as an alternative method for bile duct entry 
when conventional biliary cannulation failed, has been documented with higher 
success rate of cannulation and similar complications.  Although NKPP and TPS have 
been compared previously [7-12], randomized controlled trials on early NKP over a 
pancreatic stent comparing with TPS have been rare. The present prospective 
randomized controlled trial compared two kinds of methods in terms of success rate, 
cannulation time, and complications in the difficult cannulation. 
 
Materials and methods 
Patients and assessments 
  We will enroll ERCP-naïve patients between Nov. 2021 and Dec.2025 at Kaohsiung 
Chang Gung Memorial Hospital, Taiwan. Eligible participants were at least 20 years 
old. One experienced endoscopist (Dr. Liang), who conducted an average of 300 
ERCPs per year, performed the procedures. The study exclusion criteria included 
previous sphincterotomy, peripapillary diverticula, active pancreatitis, Prior gastric 
surgery , Current use of antiplatelet agents, Coagulopathy , Peri-ampullary tumor 
related obstruction, pregnancy , Refused or were unable to give informed consent  
Also excluded were patients with successful CBD cannulation within 5 minutes of 
standard attempts and fewer than three passages of the guidewire into the mian 
pancreatic duct (MPD) ( defined as “easy CBD cannulation”).We will gather written 
informed consent from all included patients before the trial. Before ERCP, we 
recorded the following demographic and clinical variables: age, sex, history of 

 
 
coexisting comorbidities, alcohol consumption, smoking habits, American Society of 
Anesthesiologists (ASA) score, and serum levels of albumin, C-reactive protein (CRP), 
total bilirubin, prothrombin time (PT), activated partial thromboplastin time (APTT), 
pancreas and liver function enzymes, as well as a complete and differential blood 
counts obtained in the emergency room (ER) before and after ERCP for evaluation of 
complications. Additionally, endoscopic findings were recorded, including the time 
and frequency attempts of cannulation, papilla type [13], juxtapapillary diverticulum, 
and procedure methods used.  
 
Study design 
 
 
 
The “difficult CBD cannulation” was defined as unsuccessful CBD cannulation 
after 5 minutes (stopwatch count) or three passes of the guidewire into the MPD. If 
the patients with failure cannulation to CBD and MPD for more than 5 minutes were 
treated with needle knife precut papillotomy (NKPP group) or needle knife 
fistulotomy (NKF group) according to morphology of thepapilla of Vater [13]. If the 
patients with three passes of the guidewire into the MPD were randomly assigned, in 
a 1:1 ratio, to needle knife precut papillotomy following the pancreas stent 
placement (NKP-SIPS group) or tranpancreatic sphincterotomy followed by the 
pancreas stent placement (TPS group ).  A second ERCP was planned for 4–7 days 

 
 
later for patients in whom ERCP failed. Patients are randomized into two groups at 
the time of providing informed consent by a 1:1 ratio, by opening a sealed envelope 
containing a noted marked with both groups. Individual random sequence is placed 
in an opaque envelop and kept by an independent research assistant who is not 
involved in this study.   
Primary outcome was success rate of CBD cannulation. Secondary outcomes 
included the significant complications, including post-ERCP pancreatitis (amylase 
levels higher than three times the upper reference limit accompanied by abdominal 
pain)[14], perforation, and bleeding. Bleeding complications could present as melena 
or hematemesis, with a decrease in hemoglobin concentration of at least 2 g/dL. The 
definition of bleeding degree for patients who did not require transfusion was 'mild 
bleeding degree.' Cases requiring up to four units of blood were defined as 
'moderate bleeding degree,' and those requiring five or more units of blood for 
transfusion, surgery, or angiography were defined as 'severe bleeding degree' [15]. 
Operation time during ERCP, defined as the period ranging from the beginning of 
cannulation to complete stone removal. 
 
ERCP procedure 
A side-view endoscope (JF-260V and TJF-240, Olympus Corp., Tokyo, Japan), a 
cholangiography catheter (PR-113Q, Olympus Corp., Tokyo, Japan), and a 0.035-in. 
Guidewires (Jagwire™ High Performance Guidewire; Boston Scientific, Natick, MA, 
USA) were used in the ERCP procedures. Endoscopic sphincterotomy (EST) was 
performed using standard pull-sphincterotomes (ENDO-FLEX GmbH, Voerde, 
Germany). In cases where biliary cannulation was difficult, we performed precut 
papillotomy or fistulotomy (Needle Knife, pointed type, ENDO-FLEX GmbH, Voerde, 
Germany) or transpancreatic sphincterotomy (TPS) [16]. EST was performed by using 
electrosurgical current generator Olympus ESG-100 (Olympus Optical Corporation, 
Tokyo, Japan). It was set on 20 W maximal output with pulse cut slow setting which 
cuts with alternating cutting and coagulation phase. The needle-knife precut 
techniques are freehand precut starting either from the papillary orifice (NKP) or at 
the papillary roof (needle-knife fistulotomy, NKF) after failure cannulation attempt to 
CBD and MPD for more than 5 minutes. If the papilla was treated with three 
unintended MPD cannulations, a needle-knife precut papillotomy with a small 
incision over a pancreatic stent (NKP-SIPS) [6] or TPS would be performed. With 
regard to NKP-SIPS, the direction of the incision is the same as that in NKP; 
pancreatic stent (Geenen Pancreatic Stent; Cook Medical,straight, 5 Fr/5 cm) is 
initially placed as a guide to facilitate biliary localization and to prevent post-ERCP 
pancreatitis; then, the incision is made starting at the papillary orifice, and, 

 
 
proceeding in a layer-by-layer fashion, extended upward in 1–2-mm increments, but 
not beyond the oral protrusion, to a length of less than 5 mm until the underlying 
biliary sphincter was visualized. TPS was performed as Goff reported; in short, after 
cannulation of the pancreatic duct was achieved, a pull-sphincterotome on a 
guidewire was used to cut the septum between the bile and pancreatic ducts along 
the direction from 11 o’clock to 12 o’clock. After that, the pancreatic stent is placed 
first, and the sphincterotomy is extended to expose the biliary lumen, and the biliary 
duct can be cannulated. 
A pancreas duct stent was placed for preventing post-ERCP pancreatitis (PEP) if the 
pancreas duct cannulation occurred twice or more. After ERCP, 50 mg of diclofenic 
was administered anally to all patients who did not have a history of allergy [18]. 
Aggressive intravenous hydration (including 3 mL/kg/h during ERCP, a 20-mL/kg bolus, 
and 3 mL/kg/h for eight hours after ERCP) with lactated Ringer's solution was 
administered to all patients without contraindications [19]. CBD stones were 
extracted using a balloon and/or basket catheter. A retrograde biliary drain with a 
plastic stent (ERBD) was inserted if CBD stone extraction could not be performed 
within one hour of the procedure, if the contrast medium bile flow was poor with 
papilla swelling after stone extraction, or if pus bile was noted. All patients 
underwent empiric antimicrobial treatment for acute cholangitis. All patients were 
asked to fast for at least 12 hours after ERCP and received intravenous proton pump 
inhibitors (PPIs) two doses, and then shifted to oral PPIs once daily for seven days.  
 
Block randomization 
Patients were distributed on one block with 4 numbers and each group contained two 
numbers (A, B). The admitted patients who were eligible for inclusion were given numbers in 
the order; number A was allocated to (P-stent + NKPP group) as the study group and 
patient who carried number B was allocated to ( TPS+ P-stent group ). So, the study and 
control groups were randomized into 1:1. 
 
Statistical analysis 
Descriptive statistics, including distribution, absolute frequency, relative frequency, 
medians with range, and means ± standard deviation (SDs) were calculated 
depending on the variable type. Between-group differences for quantitative variables 
with normal distribution were compared using Student's t-test. The differences 
between categorical data proportions were evaluated with Fisher's exact test when 
there were fewer than five expected cases; otherwise, we used the chi-square test. 
We included factors with probability (p) values < 0.05 in the univariate analysis in the 
logistic regression analysis. A multivariate logistic regression model was adopted to 

 
 
identify independent factors of procedural success and major adverse events. A p 
value < 0.05 was considered to indicate statistical significance in all analyses.  
 
 
Reference  
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Pár G, Párniczky A, Sarlós P, Szabó I, Szemes K, Szűcs Á, Vincze Á. Transpancreatic 
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Chang Gung Memorial Hospital, Kaohsiung Branch 
Chang Gung Medical Foundation 
Informed Consent Form 
I. Comparison of Early Needle-knife Precut Papillotomy over a Pancreatic Stent and 
Transpancreatic Sphincterotomy in Difficult Cannulation: A Prospective 
Randomized Controlled Trial 
II. Basic Study Information 
Medical Record Number: __________________ 
1. IRB Approval Number: IRB 202101221A3 
2. Study Site: Chang Gung Memorial Hospital, Kaohsiung Branch 
3. Department Responsible for Execution: Division of Gastroenterology and 
Hepatology 
4. Sponsoring Organization / Company: Chang Gung Hospital Research Project 
5. Principal Investigator: Dr. Hui-Ming Su 
Affiliation: Division of Gastroenterology and Hepatology 
Title: Attending Physician (Lecturer Level) 
Phone Number: 0975-353-218 
Co-Principal Investigator: Dr. Yi-Chun Chiu 
Associate Investigators: Dr. Chung-Mou Kuo, Dr. Chih-Ming Liang, Dr. Lung-Sheng Lu, 
Dr. Chen-Kun Wu 
Affiliation: Division of Gastroenterology and Hepatology 
Titles: Attending Physicians (Associate Professor Level, Assistant Professor Level, and 
General Attending Level) 
Phone Number: +886-7-731-7123 ext. 2444 
Emergency Contact Number for Participants: 0975-056-294 
6. Participant's Name: 
Participant Study ID Number: 
Gender: 
Date of Birth: 
Mailing Address: 
Contact Phone Number: 
 
III. Introduction 
Hello, 
Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) is the standard 
treatment for conditions such as cholangitis, bile duct stones, and obstructive jaundice. 
However, even in the hands of experienced endoscopists, successful bile duct cannulation 
may still fail in 10%–20% of cases. When standard cannulation techniques are unsuccessful, 
various precut techniques are recommended to improve the success rate. 
Early needle-knife precut sphincterotomy (performed after 5 minutes of failed cannulation) 
has been shown to be an effective method. A randomized clinical trial demonstrated that 
early use of this technique significantly reduced the incidence of post-ERCP pancreatitis. 
Compared to standard precut sphincterotomy without pancreatic duct stenting, using a small 
incision precut sphincterotomy over a pancreatic stent can further increase the success rate 
and reduce complication risks. 

 
 
Another approach, transpancreatic sphincterotomy, has also proven to yield high cannulation 
success rates with comparable complication rates. While previous studies have compared 
precut sphincterotomy and transpancreatic sphincterotomy, randomized controlled trials 
evaluating early use of both techniques with pancreatic duct stenting remain rare. For this 
reason, further investigation is warranted. 
Before you agree to participate in this study, your physician will explain the content of this 
informed consent form. Please read it carefully and ask any questions you may have. 
Participation in the study is completely voluntary, and choosing not to participate will not 
affect your legal rights to receive appropriate medical care. 
 
IV. Purpose of the Study 
To compare, in cases of difficult cannulation, the differences in success rate, cannulation 
time, and complication rate between early needle-knife precut sphincterotomy over a 
pancreatic stent and transpancreatic sphincterotomy. 
 
V. Inclusion and Exclusion Criteria 
Inclusion Criteria: 
You are eligible to participate in this study if all of the following conditions are met: 
1. Willing to sign the written informed consent form. 
2. Male or female patients aged 20 years or older. 
3. Undergoing ampullary treatment for the first time. 
Exclusion Criteria: 
You will not be eligible to participate in this study if any of the following conditions apply: 
1. Currently using non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, 
Pletaal (cilostazol), or have known coagulopathy. 
2. Biliary or gastroduodenal strictures caused by tumors. 
3. Tumors or diverticula located near the ampulla of Vater. 
4. History of prior abdominal surgery resulting in altered intestinal anatomy. 
5. Acute pancreatitis. 
6. Pregnancy. 
7. Evidence of severe infection, such as respiratory distress or unstable blood 
pressure—indicators of a serious systemic infection. 
 
VI. Study Methods and Procedures 
We will recruit approximately 400 treatment-naïve patients requiring therapeutic biliary 
endoscopy at Chang Gung Memorial Hospital, Kaohsiung, Taiwan, from November 2021 to 
October 2023. Eligible participants must be at least 20 years old. 
"Difficult biliary cannulation" is defined as failure to achieve successful bile duct cannulation 
after 5 minutes (measured with a stopwatch) or after guidewire insertion into the pancreatic 
duct on three occasions. 
Patients who fail both bile and pancreatic duct cannulation after 5 minutes will be assigned 
to one of two treatment groups based on the morphology of the ampulla: 
• 
Needle-knife precut sphincterotomy group 
• 
Needle-knife fistulotomy group 
Patients in whom the guidewire enters the pancreatic duct two times will be randomized in a 
1:1 ratio to either: 

 
 
• 
Needle-knife precut sphincterotomy after pancreatic stent placement, or 
• 
Transpancreatic sphincterotomy followed by pancreatic stent placement. 
 
Needle-knife precut sphincterotomy         Transpancreatic sphincterotomy 
 
 
 
 
 
 
VII. Potential Risks, Side Effects, Incidence Rates, and Management 
Based on previous studies, the reported risks and complications for each technique are as 
follows: 
Transpancreatic Sphincterotomy 
• 
Pancreatitis: 10.4% 
• 
Bleeding: 0–1% 
• 
Intestinal perforation: 0–1% 
• 
Mortality: 0–0.5% 
Needle-Knife Precut Sphincterotomy 
• 
Pancreatitis: 6.1% 
• 
Bleeding: 0–1% 
• 
Intestinal perforation: 0–2% 
• 
Mortality: 0–0.5% 
For participants enrolled in this study, the placement of a pancreatic duct stent may reduce 
the risk of post-procedural pancreatitis by approximately 50%. However, in very rare cases, 
the stent may migrate proximally, which may require additional endoscopic or surgical 
intervention for removal. 
After the procedure, you will be asked to fast until the following day. During this period, 
medical staff will closely monitor for abdominal pain and vital signs. Patients who 
underwent painless (sedated) endoscopy will also be observed for full recovery of 
consciousness after returning from the recovery room. 
If you experience symptoms such as abdominal bloating, pain, melena (black stool), fever, 
or confusion, please immediately inform a healthcare provider. If no such symptoms are 
present the following day, you may begin drinking water, followed by a soft or liquid diet. 
 
Management Procedures: 
1. If you experience any discomfort, please inform your attending physician. They will 
provide you with the most appropriate care and treatment. 
2. In the event of an emergency or any unusual symptoms that cannot be controlled 

 
 
with standard medical treatment, please contact your physician Dr. Chih-Ming 
Liang at 0975-056-294 or the research staff at 07-342-2121 ext. 2444 immediately. 
 
VIII. Alternative Treatment Options 
Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) is the standard 
treatment for cholangitis, bile duct stones, and obstructive jaundice. 
If you choose not to participate in this clinical trial, your physician will still provide 
appropriate treatment based on their clinical experience and the condition of your 
ampulla. For example, some physicians may be more experienced with needle-knife 
precut sphincterotomy than with transpancreatic sphincterotomy, and may therefore 
choose the technique with which they are more familiar. 
IX. Contraindications and Restrictions Related to This Study 
This study will be conducted in accordance with routine follow-up visits and standard 
medical care. You are not required to comply with any additional restrictions beyond your 
usual care. However, if any unexpected surgical procedures are needed, they should be 
discussed with your physician and properly documented. 
X. Expected Outcomes of the Study 
The early application of the two techniques, in combination with pancreatic duct stenting, 
may reduce overall complication rates. However, further research is still needed to confirm 
this potential benefit. 
XI. Emergency Management 
If you experience any discomfort or adverse symptoms during the study, please inform your 
study physician immediately. Your doctor will make every effort to provide the most 
appropriate care and treatment. 
In the event of a medical emergency or unusual physical condition that cannot be 
effectively managed with standard medication, please contact your attending physician or 
the Principal Investigator, Dr. Chih-Ming Liang (Division of Gastroenterology and 
Hepatology), at his 24-hour emergency contact number: 0975-056-294, or contact the study 
staff at +886-7-731-7123 ext. 2444. 
XII. Compensation, Cost Responsibility, and Injury Reimbursement 
1. Compensation: 
There is no monetary compensation provided for participation in this study. 
2. Cost Responsibility: 
This study is funded by research grants from Chang Gung Memorial Hospital. Under 
Taiwan’s National Health Insurance system, you will not incur any additional costs 
for participating in this study. 
(1) If an adverse event or injury occurs as a direct result of procedures conducted according 
to the study protocol, the hospital and the principal investigator will bear legal responsibility 
for providing compensation, except for adverse events that are already listed as 
foreseeable in this consent form, which will not be eligible for compensation. 
(2) In the event of an adverse reaction or injury related to this study, professional medical 
care and consultation will be provided at no cost to you. 
(3) Aside from the above-mentioned compensation and medical care, no additional 
compensation will be offered. If you are not comfortable with this level of risk or 
arrangement, you are advised not to participate in this study. 
(4) Signing this informed consent form does not waive any of your legal rights 
 
XIII. Privacy and Confidentiality Protection 

 
 
1. A unique research code will be assigned to represent your identity. This code will not 
contain your name, national ID number, or address. 
2. All diagnostic information and study findings will be handled with strict 
confidentiality by the principal investigator. If research results are published, your 
personal identity will not be disclosed. 
3. By signing this consent form, you agree that your research records may be directly 
accessed by authorized monitors, auditors, the Research Ethics Committee (IRB), and 
regulatory authorities to ensure compliance with applicable laws and regulations. 
These individuals are obligated to maintain the confidentiality of your personal 
information. 
 
XIV. Withdrawal and Discontinuation from the Study 
You, or your legal representative, have the right to withdraw from this study at any time 
and for any reason without affecting your medical care or legal rights. 
Additionally, the principal investigator may terminate your participation or halt the study if 
necessary. 
XV. Subject Rights 
1. The collection, processing, and use of your personal data will be handled by the 
study institution and investigators in accordance with this informed consent form, 
relevant clinical trial regulations, and the Personal Data Protection Act of Taiwan. 
You may exercise the following rights in writing by contacting the study institution or 
investigator: 
(1) Request to access or review your personal data; 
(2) Request a copy of your personal data; 
(3) Request to supplement or correct your personal data; 
(4) Request to stop the collection, processing, or use of your personal data; 
(5) Request deletion of your personal data. 
2. During the course of the study, you will be promptly informed of any significant new 
findings that may affect your willingness to continue participation. If you have any 
questions or concerns during the study, please contact the principal investigator. 
3. If you have questions about your rights as a research participant or believe that you 
have been harmed by participating in this study, you may contact the Institutional 
Review Board (IRB) of this hospital for consultation at: 
(03) 319-6200 ext. 3703, 3705–3709, 3711–3717 
XVI. Ownership of Study Results and Benefits 
If the results of this study lead to academic publications, tangible benefits, or other related 
outcomes, you agree that such outcomes may be donated free of charge to this hospital for 
public interest purposes, such as disease prevention, diagnosis, and treatment. 
 
XVII. Storage and Reuse of Personal Data, Samples, and Derivatives 
This study does not involve any leftover biological samples for future storage or reuse. 
 
XVIII. Declaration 
The contents of this study and the informed consent form have been fully explained orally 
to the participant by __________________. The participant and/or their legal representative 
has fully understood and agrees to participate in the study. 
This consent form is made in duplicate, and a copy has been provided to the participant. 
 
 

 
 
Signatures 
A. Participant: 
Name (Print): _______________ 
Signature: _______________ 
Date: ____ / ____ / ______ (YYYY/MM/DD) 
 
B. Person Obtaining Consent: 
Name (Print): _______________ 
Signature: _______________ 
Date: ____ / ____ / ______ (YYYY/MM/DD) 
 
C. Co-Investigator / Associate Investigator: 
Name (Print): _______________ 
Signature: _______________ 
Date: ____ / ____ / ______ (YYYY/MM/DD) 
 
D. Principal Investigator: 
Name (Print): _______________ 
Signature: _______________ 

 
 
Date: ____ / ____ / ______ (YYYY/MM/DD) 
(Required if the participant meets the condition described in Section I of the Consent 
Signing Instructions) 
 
E. Legal Representative / Authorized Consenter / Guardian / Conservator: 
Name (Print): _______________ 
Signature: _______________ 
Date: ____ / ____ / ______ (YYYY/MM/DD) 
Relationship to the Participant: _______________ 
(Required if the participant meets the condition described in Section II of the Consent 
Signing Instructions) 
 
F. Witness: 
Name (Print): _______________ 
Signature: _______________ 
Date: ____ / ____ / ______ (YYYY/MM/DD) 
 
 
 

 
 
[Chang Gung Medical Foundation / Chang Gung University / Chang Gung 
University of Science and Technology – Information for Research Participants] 
Dear Participant, Family Member, or Member of the Public, 
If you meet the eligibility criteria for a clinical trial or research study, you may be 
invited to participate in a study conducted by Chang Gung Memorial Hospital, 
Chang Gung University, or Chang Gung University of Science and Technology. The 
following information is provided to protect your safety and rights as a research 
participant. It explains the role and responsibilities of the Institutional Review 
Board (IRB) at Chang Gung Medical Foundation, how research is reviewed, and 
what your rights are as a participant. 
 
What is Research? 
Research is different from treatment. 
Treatment involves procedures and medications that have already been studied 
and are known to have predictable outcomes and side effects. Research, on the 
other hand, aims to discover new knowledge and often involves uncertainty 
about outcomes. Participation in research is completely voluntary, and 
choosing not to participate will not affect your right to receive medical care or 
result in any form of unfair treatment. 
 
What is the Institutional Review Board (IRB)? 
The Institutional Review Board (IRB) is a committee established to ensure that 
research involving human participants is scientifically and ethically appropriate. 
It is composed of medical professionals, legal experts, community 
representatives, and members of non-medical backgrounds who help 
researchers understand the concerns of participants to ensure their safety and 
rights are protected. 
If you have any questions about your rights, you may contact the IRB of Chang 
Gung Medical Foundation. 
 
How Does the IRB Review Clinical Trials or Research Studies? 
1. All research conducted at Chang Gung Memorial Hospital, Chang Gung 
University, or Chang Gung University of Science and Technology must be 
reviewed and approved by the IRB before it can begin. 
2. Research protocols submitted to the IRB are independently and professionally 
reviewed by committee members and experts. 
The review focuses on whether participants are fully informed about the 
study — including: 
o The purpose of the study 
o The procedures involved 
o Possible alternative treatments 
o Potential risks, side effects, and benefits 
o How to withdraw from the study 
o How privacy and confidentiality will be protected 
3. During review, the IRB evaluates potential risks to participants, which may 
include: 
o Physical discomfort or harm 
o Psychological stress 
o Social or financial impact 
The IRB ensures that all risks are minimized and justified by the potential 
benefits — either to the participant, or to future patients through scientific 
knowledge. 
Studies that pose high risk with no reasonable benefit will not be approved. 

 
 
4. After a study is approved, the IRB and the research institution will continue 
monitoring the research to ensure that it is carried out exactly as approved 
and that participants’ rights and safety remain protected. 
 
What Are Your Rights as a Research Participant? 
 
Right to Be Informed 
You have the right to clear and complete information about: 
1. Purpose of the study 
The researcher must explain the aim of the study in simple and 
understandable language. 
2. What will happen during the study 
You should know what procedures will be involved, how often visits occur, 
whether blood samples will be taken, and any inconvenience to your daily 
life. 
3. Alternative treatment options 
You have the right to know about other treatments available if you choose 
not to participate. 
4. Risks and side effects 
All research involves risk. You must be informed of potential risks and side 
effects, and what to do in case of an emergency — including who to contact 
and who will provide follow-up medical care and cover related costs. 
5. Potential benefits and expected outcomes 
Researchers must explain any direct benefits to you, or how the study may 
help others in the future through new discoveries. 
6. How to withdraw from the study 
You must be informed about how to withdraw at any time, what happens to 
your data after withdrawal, and whether follow-up care is available. 
7. Freedom to ask questions 
You may ask the research team questions at any time. 
 
 
Right to Voluntary Participation 
You will only officially become a participant after the researcher explains the 
study purpose, procedures, risks, benefits, and your rights, and after you sign 
the informed consent form of your own free will. 
You may also withdraw at any time without giving a reason. 
Your decision to withdraw will not affect your future medical care or cause you 
to be treated unfairly. 
 
 
Right to Protection 
1. Privacy and confidentiality 
Any personal information collected during the study will be kept confidential. 
If study results are published, or reviewed by the IRB or regulatory agencies 
(e.g., the Ministry of Health and Welfare), your identity will not be revealed. 
2. Retention of your legal rights 
Participation in a clinical study does not mean you give up any legal rights 
you currently have