Surgery, Major PancreaticNCT07450950
Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease
An observational study of Surgery, Major Pancreatic and Surgery, Major Hepatic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Patients undergoing major abdominal surgery often have to make complex decisions about their treatment, where risks, benefits and possible complications must be considered. Limited health literacy and unmet expectations can make this process difficult and may increase the risk of regret after surgery, as well as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Major Pancreatic, Surgery, Major Hepatic, Large Bowel/Sarcoma Resections
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo major surgery in the pancreas, liver, esophagus or stomach at Copenhagen University Hospital, Rigshospitalet
Who may be able to join
- Patients > 18 years undergoing elective surgical treatment.
- Patients who can read and understand the Danish language.
Who cannot join
- Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator.
- In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amalie W. H. Westergaard, Medical student contact
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Copenhagen, 2100
About this study
Patients undergoing major abdominal surgery often have to make complex decisions about their treatment, where risks, benefits and possible complications must be considered. Limited health literacy and unmet expectations can make this process difficult and may increase the risk of regret after surgery, as well as feelings of not having received sufficient support or clear information.
The aim of this study is to explore how well patients understand the information they receive before surgery, what expectations they have and how these expectations relate to their postoperative experiences. The study includes patients undergoing major abdominal cancer surgery, such as pancreatic, liver, esophageal, gastric, or large bowel surgery, at Copenhagen University Hospital, Rigshospitalet. Data will be collected before surgery, one month after discharge and again three months later.
Read the detailed description
Patients undergoing major abdominal cancer surgery often face complex treatment decisions that involve weighing potential benefits against significant risks, including postoperative complications and prolonged recovery. In such situations, adequate patient information, realistic expectations and sufficient health literacy may be essential for supporting informed decision-making. When patients feel insufficiently informed or experience a mismatch between their expectations and postoperative outcomes, this may contribute to decision regret and reduced quality of life.
The purpose of this study is to explore the relationship between health literacy, preoperative information, patient expectations, and postoperative experiences in patients undergoing major abdominal cancer surgery. In particular, the study will examine how these factors relate to postoperative decision regret and health-related quality of life.
This is a prospective observational cohort study conducted at the Department of Transplantation and Digestive Diseases at Copenhagen University Hospital, Rigshospitalet, Denmark. Patients undergoing major abdominal cancer surgery, including pancreatic, hepatic, esophageal, gastric, and major colorectal procedures, will be invited to participate.
Data will be collected at baseline before surgery and at follow-up approximately one month and three months after surgery. Participants will complete validated questionnaires about health literacy, treatment expectations, perceived information received before surgery, anxiety and depression, decision regret and health-related quality of life. In addition, a subgroup of participants will be invited to participate in semi-structured qualitative interviews to explore how their preoperative expectations correspond with their postoperative experiences.
The study aims to improve understanding of how patient-related factors such as health literacy and expectations influence postoperative experiences and decision regret. The findings may contribute to a better understanding of factors associated with postoperative decision regret and patient-reported outcomes following major abdominal cancer surgery.
- Conditions
- Surgery, Major Pancreatic, Surgery, Major Hepatic, Large Bowel/Sarcoma Resections, Surgery, Major Esophageal or Stomach
- Keywords
- Health literacy, Patient expectations, Expectations, Decision, Regret, Quality of life, Major abdominal surgery, Pancreatic surgery, Hepatic surgery, Esophageal surgery, Gastric surgery, Prospective cohort study, Qualitative interviews, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery, major pancreatic | Whipples resection, total pancreatectomy or distal pancreatectomy | |
| Surgery, major hepatic | Hilar cholangiocarcinoma, major liver resection (3 segments or more) | |
| Large bowel/sarcoma resections | Not described | |
| Surgery, major esophageal or stomach | Ivor Lewis esophagectomy, total or subtotal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative decision regrets
Decision regret will be measured using the Danish version of the Decision Regret Scale (DRS). The scale consists of 5 items assessing the degree of regret following the surgical decision. Each item is rated on a 5-point scale, and the total score is transformed to a 0-100 scale, where 0 indicates no regret and 100 indicates high regret.
Measured: 1 month, and 3 months
Secondary outcomes (6)
Preoperative anxiety and depression
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The questionnaire contains 14 questions divided into two subgroups (anxiety and depression). Therefore there are 7 questions for each and is scored from 0 to 3 resulting in a total score ranging from 0 to 21 for each subgroup. Higher scores indicate higher levels of anxiety or depression.
Measured: Baseline
Quality of information
Patients' satisfaction with the information provided before surgery will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information Module (EORTC QLQ-INFO25). The instrument assesses perceived information received about disease, medical tests, treatment, and other services. Scores range from 0 to 100, with higher scores indicating higher satisfaction with information.
Measured: Perioperative
Patients' preoperative expectations
Patients' preoperative expectations evaluated by The Treatment Expectation Questionnaire (TEX-Q). The questionnaire contains 15 questions where the patient can rate their expectations from 0 to 10. 0 indicates their expectations of no relief, no benefit or no improvement, whereas 10 represents the opposite.
Measured: Baseline
Health literacy
Health literacy will be measured using the Brief Health Literacy Scale, which evaluates patients' ability to understand and use health-related information. Higher scores indicate higher levels of health literacy.
Measured: Baseline
Fulfillment of patient expectations
Fulfillment of preoperative expectations will be explored 14-30 days after surgery using a short semi-structured interview. Patients will be asked to reflect on how their expectations compared to their actual postoperative experiences.
Measured: 1 month
Health-related quality of life
Health-related quality of life will be measured using EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), which includes five domains: mobility, personal care, activities, pain/discomfort, and anxiety/depression. Each area has five response levels ranging from "no problems" to "extreme problems." In addition, patients will rate their overall health on a visual analog scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). The patient will mark on the number indicating the self-evaluated health.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Nov 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Surgery, Major PancreaticStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Edith Geisler, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450950
- Sponsor's protocol ID
- AW-regrets25
- Status last verified
- Oct 2025
- First submitted
- 24 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
PubMed 12926578Jensen MB, Jensen CE, Gudex C, Pedersen KM, Sorensen SS, Ehlers LH. Danish population health measured by the EQ-5D-5L. Scand J Public Health. 2023 Mar;51(2):241-249. doi: 10.1177/14034948211058060. Epub 2021 Nov 30.
PubMed 34847818Djukanovic I, Carlsson J, Arestedt K. Is the Hospital Anxiety and Depression Scale (HADS) a valid measure in a general population 65-80 years old? A psychometric evaluation study. Health Qual Life Outcomes. 2017 Oct 4;15(1):193. doi: 10.1186/s12955-017-0759-9.
PubMed 28978356Shedden-Mora MC, Alberts J, Petrie KJ, Laferton JAC, von Blanckenburg P, Kohlmann S, Nestoriuc Y, Lowe B. The Treatment Expectation Questionnaire (TEX-Q): Validation of a generic multidimensional scale measuring patients' treatment expectations. PLoS One. 2023 Jan 23;18(1):e0280472. doi: 10.1371/journal.pone.0280472. eCollection 2023.
PubMed 36689398Kong H, West S. WMA DECLARATION OF HELSINKI - ETHICAL PRINCIPLES FOR Scientic Requirements and Research Protocols. 2013;(June 1964):29-32.
Hickmann E, Richter P, Schlieter H. All together now - patient engagement, patient empowerment, and associated terms in personal healthcare. BMC Health Serv Res. 2022 Sep 2;22(1):1116. doi: 10.1186/s12913-022-08501-5.
PubMed 36056354Holden CE, Wagland R, Harle A, Wheelwright S. The experiences and decision making of patients with incurable cancer and health literacy difficulties. PLoS One. 2024 Oct 3;19(10):e0309104. doi: 10.1371/journal.pone.0309104. eCollection 2024.
PubMed 39361567van der Weijden T, van der Kraan J, Brand PLP, van Veenendaal H, Drenthen T, Schoon Y, Tuyn E, van der Weele G, Stalmeier P, Damman OC, Stiggelbout A. Shared decision-making in the Netherlands: Progress is made, but not for all. Time to become inclusive to patients. Z Evid Fortbild Qual Gesundhwes. 2022 Jun;171:98-104. doi: 10.1016/j.zefq.2022.04.029. Epub 2022 May 23.
PubMed 35613990Becerra Perez MM, Menear M, Brehaut JC, Legare F. Extent and Predictors of Decision Regret about Health Care Decisions: A Systematic Review. Med Decis Making. 2016 Aug;36(6):777-90. doi: 10.1177/0272989X16636113. Epub 2016 Mar 14.
PubMed 26975351Mohamed Mohamed WJ, Joseph L, Canby G, Paungmali A, Sitilertpisan P, Pirunsan U. Are patient expectations associated with treatment outcomes in individuals with chronic low back pain? A systematic review of randomised controlled trials. Int J Clin Pract. 2020 Nov;74(11):e13680. doi: 10.1111/ijcp.13680. Epub 2020 Sep 7.
PubMed 33166045Chichua M, Brivio E, Mazzoni D, Pravettoni G. Shared decision-making and the lessons learned about decision regret in cancer patients. Support Care Cancer. 2022 Jun;30(6):4587-4590. doi: 10.1007/s00520-021-06725-5. Epub 2022 Jan 15.
PubMed 35031827Pel-Littel RE, Buurman BM, Minkman MM, Scholte Op Reimer WJM, Twisk JWR, van Weert JCM. The influence of health literacy, anxiety and education on shared decision making and decisional conflict in older adults, and the mediating role of patient participation: A video observational study. Patient Educ Couns. 2024 Jul;124:108274. doi: 10.1016/j.pec.2024.108274. Epub 2024 Mar 22.
PubMed 38547640Muscat DM, Shepherd HL, Nutbeam D, Trevena L, McCaffery KJ. Health Literacy and Shared Decision-making: Exploring the Relationship to Enable Meaningful Patient Engagement in Healthcare. J Gen Intern Med. 2021 Feb;36(2):521-524. doi: 10.1007/s11606-020-05912-0. Epub 2020 May 29.
PubMed 32472490
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease
- ClinicalTrials.gov ID
- NCT07450950
- Acronym / sponsor ID
- AW-regrets25
- Conditions
- Surgery, Major Pancreatic, Surgery, Major Hepatic, Large Bowel/Sarcoma Resections, Surgery, Major Esophageal or Stomach
- Keywords
- Health literacy, Patient expectations, Expectations, Decision, Regret, Quality of life, Major abdominal surgery, Pancreatic surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing major abdominal surgery often have to make complex decisions about their treatment, where risks, benefits and possible complications must be considered. Limited health literacy and unmet expectations can make this process difficult and may increase the risk of regret after surgery, as well as feelings of not having received sufficient support or clear information.
The aim of this study is to explore how well patients understand the information they receive before surgery, what expectations they have and how these expectations relate to their postoperative experiences. The study includes patients undergoing major abdominal cancer surgery, such as pancreatic, liver, esophageal, gastric, or large bowel surgery, at Copenhagen University Hospital, Rigshospitalet. Data will be collected before surgery, one month after discharge and again three months later.
Detailed description
Patients undergoing major abdominal cancer surgery often face complex treatment decisions that involve weighing potential benefits against significant risks, including postoperative complications and prolonged recovery. In such situations, adequate patient information, realistic expectations and sufficient health literacy may be essential for supporting informed decision-making. When patients feel insufficiently informed or experience a mismatch between their expectations and postoperative outcomes, this may contribute to decision regret and reduced quality of life.
The purpose of this study is to explore the relationship between health literacy, preoperative information, patient expectations, and postoperative experiences in patients undergoing major abdominal cancer surgery. In particular, the study will examine how these factors relate to postoperative decision regret and health-related quality of life.
This is a prospective observational cohort study conducted at the Department of Transplantation and Digestive Diseases at Copenhagen University Hospital, Rigshospitalet, Denmark. Patients undergoing major abdominal cancer surgery, including pancreatic, hepatic, esophageal, gastric, and major colorectal procedures, will be invited to participate.
Data will be collected at baseline before surgery and at follow-up approximately one month and three months after surgery. Participants will complete validated questionnaires about health literacy, treatment expectations, perceived information received before surgery, anxiety and depression, decision regret and health-related quality of life. In addition, a subgroup of participants will be invited to participate in semi-structured qualitative interviews to explore how their preoperative expectations correspond with their postoperative experiences.
The study aims to improve understanding of how patient-related factors such as health literacy and expectations influence postoperative experiences and decision regret. The findings may contribute to a better understanding of factors associated with postoperative decision regret and patient-reported outcomes following major abdominal cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgery, major pancreatic | – | –Whipples resection, total pancreatectomy or distal pancreatectomy |
| Surgery, major hepatic | – | –Hilar cholangiocarcinoma, major liver resection (3 segments or more) |
| Large bowel/sarcoma resections | – | – |
| Surgery, major esophageal or stomach | – | –Ivor Lewis esophagectomy, total or subtotal gastrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo major surgery in the pancreas, liver, esophagus or stomach at Copenhagen University Hospital, Rigshospitalet
Key inclusion criteria (2 listed)
- Patients > 18 years undergoing elective surgical treatment.
- Patients who can read and understand the Danish language.
Key exclusion criteria (2 listed)
- Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator.
- In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative decision regrets
Time frame: 1 month, and 3 months
Decision regret will be measured using the Danish version of the Decision Regret Scale (DRS). The scale consists of 5 items assessing the degree of regret following the surgical decision. Each item is rated on a 5-point scale, and the total score is transformed to a 0-100 scale, where 0 indicates no regret and 100 indicates high regret.
6 secondary outcomes
Preoperative anxiety and depression
Time frame: Baseline
Quality of information
Time frame: Perioperative
Patients' preoperative expectations
Time frame: Baseline
Health literacy
Time frame: Baseline
Fulfillment of patient expectations
Time frame: 1 month
Health-related quality of life
Time frame: Baseline, 1 month, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 12926578Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
- Background: PubMed 34847818Jensen MB, Jensen CE, Gudex C, Pedersen KM, Sorensen SS, Ehlers LH. Danish population health measured by the EQ-5D-5L. Scand J Public Health. 2023 Mar;51(2):241-249. doi: 10.1177/14034948211058060. Epub 2021 Nov 30.
- Background: PubMed 28978356Djukanovic I, Carlsson J, Arestedt K. Is the Hospital Anxiety and Depression Scale (HADS) a valid measure in a general population 65-80 years old? A psychometric evaluation study. Health Qual Life Outcomes. 2017 Oct 4;15(1):193. doi: 10.1186/s12955-017-0759-9.
- Background: PubMed 36689398Shedden-Mora MC, Alberts J, Petrie KJ, Laferton JAC, von Blanckenburg P, Kohlmann S, Nestoriuc Y, Lowe B. The Treatment Expectation Questionnaire (TEX-Q): Validation of a generic multidimensional scale measuring patients' treatment expectations. PLoS One. 2023 Jan 23;18(1):e0280472. doi: 10.1371/journal.pone.0280472. eCollection 2023.
- BackgroundKong H, West S. WMA DECLARATION OF HELSINKI - ETHICAL PRINCIPLES FOR Scientic Requirements and Research Protocols. 2013;(June 1964):29-32.
- Background: PubMed 36056354Hickmann E, Richter P, Schlieter H. All together now - patient engagement, patient empowerment, and associated terms in personal healthcare. BMC Health Serv Res. 2022 Sep 2;22(1):1116. doi: 10.1186/s12913-022-08501-5.
- Background: PubMed 39361567Holden CE, Wagland R, Harle A, Wheelwright S. The experiences and decision making of patients with incurable cancer and health literacy difficulties. PLoS One. 2024 Oct 3;19(10):e0309104. doi: 10.1371/journal.pone.0309104. eCollection 2024.
- Background: PubMed 35613990van der Weijden T, van der Kraan J, Brand PLP, van Veenendaal H, Drenthen T, Schoon Y, Tuyn E, van der Weele G, Stalmeier P, Damman OC, Stiggelbout A. Shared decision-making in the Netherlands: Progress is made, but not for all. Time to become inclusive to patients. Z Evid Fortbild Qual Gesundhwes. 2022 Jun;171:98-104. doi: 10.1016/j.zefq.2022.04.029. Epub 2022 May 23.
- Background: PubMed 26975351Becerra Perez MM, Menear M, Brehaut JC, Legare F. Extent and Predictors of Decision Regret about Health Care Decisions: A Systematic Review. Med Decis Making. 2016 Aug;36(6):777-90. doi: 10.1177/0272989X16636113. Epub 2016 Mar 14.
- Background: PubMed 33166045Mohamed Mohamed WJ, Joseph L, Canby G, Paungmali A, Sitilertpisan P, Pirunsan U. Are patient expectations associated with treatment outcomes in individuals with chronic low back pain? A systematic review of randomised controlled trials. Int J Clin Pract. 2020 Nov;74(11):e13680. doi: 10.1111/ijcp.13680. Epub 2020 Sep 7.
- Background: PubMed 35031827Chichua M, Brivio E, Mazzoni D, Pravettoni G. Shared decision-making and the lessons learned about decision regret in cancer patients. Support Care Cancer. 2022 Jun;30(6):4587-4590. doi: 10.1007/s00520-021-06725-5. Epub 2022 Jan 15.
- Background: PubMed 38547640Pel-Littel RE, Buurman BM, Minkman MM, Scholte Op Reimer WJM, Twisk JWR, van Weert JCM. The influence of health literacy, anxiety and education on shared decision making and decisional conflict in older adults, and the mediating role of patient participation: A video observational study. Patient Educ Couns. 2024 Jul;124:108274. doi: 10.1016/j.pec.2024.108274. Epub 2024 Mar 22.
- Muscat DM, Shepherd HL, Nutbeam D, Trevena L, McCaffery KJ. Health Literacy and Shared Decision-making: Exploring the Relationship to Enable Meaningful Patient Engagement in Healthcare. J Gen Intern Med. februar 2021;36(2):521-4.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amalie W. H. Westergaard, Medical student contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, Major Pancreatic and Surgery, Major Hepatic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amalie W. H. Westergaard, Medical student (+4560528807, amalie.winding.hjortshoej.westergaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative decision regrets (time frame: 1 month, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07450950, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.