Hepatic CarcinomaPhase 2NCT06085976
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
A Phase 2 study testing Octreotide in people with Hepatic Carcinoma and Hepatic Metastasis, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The goal of this double-blind clinical trial is to compare the efficacy of octreotide versus placebo in laparoscopic hepatectomy surgery in patients diagnosed with resectable hepatocarcinoma or liver metastases. The main questions it aims to answer are: Decrease in intraoperative bleeding measured in ml of blood lost. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Carcinoma, Hepatic Metastasis
- What is being tested?
- Octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 14 Aug 2023to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with hepatic lesions who are going to undergo hepatectomy via laparoscopy.
- The patient must be between 18 and 80 years old.
- The patient, or his/her representative, has given his/her consent to participate in the study.
- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- The patient must not be allergic to the drug.
Who cannot join
- History of hypersensitivity to the drug to be administered.
- Children under 18 years of age.
- Urgent intervention.
- Intervention performed in an open manner (not laparoscopic).
- Patient's refusal to participate in the study.
- Contraindication to receive octreotide.
- Women of childbearing age (those women who are in the period between menarche and menopause). Having to present a negative pregnancy test to take part in the study.
- Pregnant or lactating women, given the absence of studies of this drug in this patient profile.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinica Universidad de Navarra
Pamplona, 31007
Marta MA Luque Pelaez, Doctor, 664192399 ext. +34, mluquepe@unav.es
About this study
The goal of this double-blind clinical trial is to compare the efficacy of octreotide versus placebo in laparoscopic hepatectomy surgery in patients diagnosed with resectable hepatocarcinoma or liver metastases.
The main questions it aims to answer are:
- Decrease in intraoperative bleeding measured in ml of blood lost.
- Decrease in the need for blood transfusion and use of intraoperative vasoactive drugs.
Participants will receive octreotide or placebo after signing the informed consent form.
Read the detailed description
The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.
The patient will not receive any visit or require the performance of any other additional tests that are performed in the usual clinical practice. The monthly follow-up will coincide with the medical check-up and control analytical data will be taken. Subsequently, an attempt will be made to contact with the patient 3 months after surgery.
The duration of participation of each participant in the trial will therefore be about 3 months after surgery.
The intervention group will receive a loading dose of octreotide (100 mcgr) diluted in 100 ml of SSF to be given in half an hour and after that a continuous perfusion of 25 mcgr/h will be started until the end of the surgery.
The pharmaceutical form to be used is Sandostatin.
The control group will receive SSF as a placebo in the same sequence, first a loading dose in half an hour and then a continuous infusion of 25 mcgr/h until the end of surgery.
and then a continuous infusion until the end of the surgery.
- Conditions
- Hepatic Carcinoma, Hepatic Metastasis
- Being tested
- Octreotide, Placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Also called Placebo
A loading dose of 100 mcgr of octreotide will be administered in the intervention group, diluted in 100 ml of SSF to be passed in 30 minutes.
Subsequently, it will be administered in continuous perfusion at 25 mcgr/h in the intervention group.
The drug can be administered through a peripheral or central venous line at the choice of the anesthesiologist, since the drug has a density that allows its administration by both routes.
PlaceboOther
In the case of the control group, 100 ml of SSF will be administered to be passed in half an hour and then an perfusion of SSF.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (octreotide) | Experimental | This patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h Receives: Drug: Octreotide |
| Placebo arm (saline solution) | Experimental | This patient will receive physiologic saline solution at the same infusion Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence on intraoperative bleeding.
Decrease in intraoperative bleeding measured in ml of blood lost during laparoscopic liver resection surgery via laparoscopy.
Measured: During the time the surgery lasts.
Secondary outcomes (5)
Rate of intraoperative hemodynamic stability.
Intraoperative hemodynamic stability through haemodynamics variables.
Measured: During the time the surgery lasts.
Incidence of intraoperative transfusion.
Decrease in transfusion during surgery due to bleeding versus placebo
Measured: During the time the surgery lasts.
Number of patients with vasoactive use.
Decrease in use of vasoactive drugs due to hemodynamic instability versus placebo
Measured: During the time the surgery lasts.
Incidence on the improvement of hepatic function
Observe the effects on postoperative liver function, reduction of liver enzymes.
Measured: Up to 90 days
Rate of postoperative complications
Observe the effects on postoperative complications versus placebo
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start14 Aug 2023
- Primary completion14 Aug 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Hepatic CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085976
- Sponsor's protocol ID
- HEPA-OCT
- Status last verified
- Jul 2023
- First submitted
- 19 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huaringa-Marcelo J, Huaman MR, Branez-Condorena A, Villacorta-Landeo P, Pinto-Ruiz DF, Urday-Ipanaque D, Garcia-Gomero D, Montes-Teves P, Lozano Miranda A. Vasoactive Agents for the Management of Acute Variceal Bleeding: A Systematic Review and Meta-analysis. J Gastrointestin Liver Dis. 2021 Mar 13;30(1):110-121. doi: 10.15403/jgld-3191.
PubMed 33723542Condron ME, Pommier SJ, Pommier RF. Continuous infusion of octreotide combined with perioperative octreotide bolus does not prevent intraoperative carcinoid crisis. Surgery. 2016 Jan;159(1):358-65. doi: 10.1016/j.surg.2015.05.036. Epub 2015 Oct 23.
PubMed 26603846Lu SC, Meng FK, Ding HG, Zhang JG, Ding L, Wang SZ. [Effects of two different dosages of octreotide on portal pressure and hepatic hemodynamics in cirrhotic portal hypertensive patients after portal-azygous devascularization and splenectomy]. Zhonghua Nei Ke Za Zhi. 2007 Apr;46(4):290-3. Chinese.
PubMed 17637266Weingarten TN, Abel MD, Connolly HM, Schroeder DR, Schaff HV. Intraoperative management of patients with carcinoid heart disease having valvular surgery: a review of one hundred consecutive cases. Anesth Analg. 2007 Nov;105(5):1192-9, table of contents. doi: 10.1213/01.ane.0000284704.57806.0b.
PubMed 17959940Woltering EA, Wright AE, Stevens MA, Wang YZ, Boudreaux JP, Mamikunian G, Riopelle JM, Kaye AD. Development of effective prophylaxis against intraoperative carcinoid crisis. J Clin Anesth. 2016 Aug;32:189-93. doi: 10.1016/j.jclinane.2016.03.008. Epub 2016 Apr 20.
PubMed 27290972Dahaba AA, Mueller G, Mattiassich G, Rumpold-Seitlinger G, Bornemann H, Rehak PH, Linck G, Mischinger HJ, Metzler H. Effect of somatostatin analogue octreotide on pain relief after major abdominal surgery. Eur J Pain. 2009 Sep;13(8):861-4. doi: 10.1016/j.ejpain.2008.10.006. Epub 2008 Dec 11.
PubMed 19084439Suc B, Msika S, Piccinini M, Fourtanier G, Hay JM, Flamant Y, Fingerhut A, Fagniez PL, Chipponi J; French Associations for Surgical Research. Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial. Arch Surg. 2004 Mar;139(3):288-94; discussion 295. doi: 10.1001/archsurg.139.3.288.
PubMed 15006886Latchana N, Hirpara DH, Hallet J, Karanicolas PJ. Red blood cell transfusion in liver resection. Langenbecks Arch Surg. 2019 Feb;404(1):1-9. doi: 10.1007/s00423-018-1746-2. Epub 2019 Jan 3.
PubMed 30607533Hallet J, Tsang M, Cheng ES, Habashi R, Kulyk I, Hanna SS, Coburn NG, Lin Y, Law CH, Karanicolas PJ. The Impact of Perioperative Red Blood Cell Transfusions on Long-Term Outcomes after Hepatectomy for Colorectal Liver Metastases. Ann Surg Oncol. 2015 Nov;22(12):4038-45. doi: 10.1245/s10434-015-4477-4. Epub 2015 Mar 10.
PubMed 25752895Wang C, Han J, Xiao L, Jin CE, Li DJ, Yang Z. Efficacy of vasopressin/terlipressin and somatostatin/octreotide for the prevention of early variceal rebleeding after the initial control of bleeding: a systematic review and meta-analysis. Hepatol Int. 2015 Jan;9(1):120-9. doi: 10.1007/s12072-014-9594-9. Epub 2014 Dec 5.
PubMed 25788386Li JJ, Chao P, Gernsheimer J, Verma R. Octreotide for Gastrointestinal Hemorrhage from Esophageal Varices. Acad Emerg Med. 2020 Apr;27(4):339-340. doi: 10.1111/acem.13901. Epub 2019 Dec 31. No abstract available.
PubMed 31821652Berreta J, Kociak D, Romero G, Balducci A, Amaya R, Argonz J. [Endoscopic versus endoscopic plus octreotide treatment for acute variceal bleeding. Benefit according to severity at admission]. Acta Gastroenterol Latinoam. 2013 Jun;43(2):89-97. Spanish.
PubMed 23940908Sung JJ, Chung SC, Yung MY, Lai CW, Lau JY, Lee YT, Leung VK, Li MK, Li AK. Prospective randomised study of effect of octreotide on rebleeding from oesophageal varices after endoscopic ligation. Lancet. 1995 Dec 23-30;346(8991-8992):1666-9. doi: 10.1016/s0140-6736(95)92840-5.
PubMed 8551824Iannone A, Principi M, Barone M, Losurdo G, Ierardi E, Di Leo A. Gastrointestinal bleeding from vascular malformations: Is octreotide effective to rescue difficult-to-treat patients? Clin Res Hepatol Gastroenterol. 2016 Sep;40(4):373-7. doi: 10.1016/j.clinre.2016.02.003. Epub 2016 Aug 29.
PubMed 27595456Fabes J, Ambler G, Shah B, Williams NR, Martin D, Davidson BR, Spiro M. Protocol for a prospective double-blind, randomised, placebo-controlled feasibility trial of octreotide infusion during liver transplantation. BMJ Open. 2021 Dec 2;11(12):e055864. doi: 10.1136/bmjopen-2021-055864.
PubMed 34857585
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
- ClinicalTrials.gov ID
- NCT06085976
- Acronym / sponsor ID
- HEPA-OCT
- Conditions
- Hepatic Carcinoma, Hepatic Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 14 Aug 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 17 Oct 2023 (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.
The goal of this double-blind clinical trial is to compare the efficacy of octreotide versus placebo in laparoscopic hepatectomy surgery in patients diagnosed with resectable hepatocarcinoma or liver metastases.
The main questions it aims to answer are:
- Decrease in intraoperative bleeding measured in ml of blood lost.
- Decrease in the need for blood transfusion and use of intraoperative vasoactive drugs.
Participants will receive octreotide or placebo after signing the informed consent form.
Detailed description
The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.
The patient will not receive any visit or require the performance of any other additional tests that are performed in the usual clinical practice. The monthly follow-up will coincide with the medical check-up and control analytical data will be taken. Subsequently, an attempt will be made to contact with the patient 3 months after surgery.
The duration of participation of each participant in the trial will therefore be about 3 months after surgery.
The intervention group will receive a loading dose of octreotide (100 mcgr) diluted in 100 ml of SSF to be given in half an hour and after that a continuous perfusion of 25 mcgr/h will be started until the end of the surgery.
The pharmaceutical form to be used is Sandostatin.
The control group will receive SSF as a placebo in the same sequence, first a loading dose in half an hour and then a continuous infusion of 25 mcgr/h until the end of surgery.
and then a continuous infusion until the end of the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm (octreotide) | Experimental | Drug: OctreotideThis patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h |
| Placebo arm (saline solution) | Experimental | Other: PlaceboThis patient will receive physiologic saline solution at the same infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with hepatic lesions who are going to undergo hepatectomy via laparoscopy.
- The patient must be between 18 and 80 years old.
- The patient, or his/her representative, has given his/her consent to participate in the study.
- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- The patient must not be allergic to the drug.
Key exclusion criteria (8 listed)
- History of hypersensitivity to the drug to be administered.
- Children under 18 years of age.
- Urgent intervention.
- Intervention performed in an open manner (not laparoscopic).
- Patient's refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctreotideAlso: PlaceboA loading dose of 100 mcgr of octreotide will be administered in the intervention group, diluted in 100 ml of SSF to be passed in 30 minutes. Subsequently, it will be administered in continuous perfusion at 25 mcgr/h in the intervention group. The drug can be administered through a peripheral or central venous line at the choice of the anesthesiologist, since the drug has a density that allows its administration by both routes. | Drug | Treatment arm (octreotide) |
| PlaceboIn the case of the control group, 100 ml of SSF will be administered to be passed in half an hour and then an perfusion of SSF. | Other | Placebo arm (saline solution) |
Primary outcome
Incidence on intraoperative bleeding.
Time frame: During the time the surgery lasts.
Decrease in intraoperative bleeding measured in ml of blood lost during laparoscopic liver resection surgery via laparoscopy.
5 secondary outcomes
Rate of intraoperative hemodynamic stability.
Time frame: During the time the surgery lasts.
Incidence of intraoperative transfusion.
Time frame: During the time the surgery lasts.
Number of patients with vasoactive use.
Time frame: During the time the surgery lasts.
Incidence on the improvement of hepatic function
Time frame: Up to 90 days
Rate of postoperative complications
Time frame: Up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 33723542Huaringa-Marcelo J, Huaman MR, Branez-Condorena A, Villacorta-Landeo P, Pinto-Ruiz DF, Urday-Ipanaque D, Garcia-Gomero D, Montes-Teves P, Lozano Miranda A. Vasoactive Agents for the Management of Acute Variceal Bleeding: A Systematic Review and Meta-analysis. J Gastrointestin Liver Dis. 2021 Mar 13;30(1):110-121. doi: 10.15403/jgld-3191.
- Background: PubMed 26603846Condron ME, Pommier SJ, Pommier RF. Continuous infusion of octreotide combined with perioperative octreotide bolus does not prevent intraoperative carcinoid crisis. Surgery. 2016 Jan;159(1):358-65. doi: 10.1016/j.surg.2015.05.036. Epub 2015 Oct 23.
- Background: PubMed 17637266Lu SC, Meng FK, Ding HG, Zhang JG, Ding L, Wang SZ. [Effects of two different dosages of octreotide on portal pressure and hepatic hemodynamics in cirrhotic portal hypertensive patients after portal-azygous devascularization and splenectomy]. Zhonghua Nei Ke Za Zhi. 2007 Apr;46(4):290-3. Chinese.
- Background: PubMed 17959940Weingarten TN, Abel MD, Connolly HM, Schroeder DR, Schaff HV. Intraoperative management of patients with carcinoid heart disease having valvular surgery: a review of one hundred consecutive cases. Anesth Analg. 2007 Nov;105(5):1192-9, table of contents. doi: 10.1213/01.ane.0000284704.57806.0b.
- Background: PubMed 27290972Woltering EA, Wright AE, Stevens MA, Wang YZ, Boudreaux JP, Mamikunian G, Riopelle JM, Kaye AD. Development of effective prophylaxis against intraoperative carcinoid crisis. J Clin Anesth. 2016 Aug;32:189-93. doi: 10.1016/j.jclinane.2016.03.008. Epub 2016 Apr 20.
- Background: PubMed 19084439Dahaba AA, Mueller G, Mattiassich G, Rumpold-Seitlinger G, Bornemann H, Rehak PH, Linck G, Mischinger HJ, Metzler H. Effect of somatostatin analogue octreotide on pain relief after major abdominal surgery. Eur J Pain. 2009 Sep;13(8):861-4. doi: 10.1016/j.ejpain.2008.10.006. Epub 2008 Dec 11.
- Background: PubMed 15006886Suc B, Msika S, Piccinini M, Fourtanier G, Hay JM, Flamant Y, Fingerhut A, Fagniez PL, Chipponi J; French Associations for Surgical Research. Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial. Arch Surg. 2004 Mar;139(3):288-94; discussion 295. doi: 10.1001/archsurg.139.3.288.
- Background: PubMed 30607533Latchana N, Hirpara DH, Hallet J, Karanicolas PJ. Red blood cell transfusion in liver resection. Langenbecks Arch Surg. 2019 Feb;404(1):1-9. doi: 10.1007/s00423-018-1746-2. Epub 2019 Jan 3.
- Background: PubMed 25752895Hallet J, Tsang M, Cheng ES, Habashi R, Kulyk I, Hanna SS, Coburn NG, Lin Y, Law CH, Karanicolas PJ. The Impact of Perioperative Red Blood Cell Transfusions on Long-Term Outcomes after Hepatectomy for Colorectal Liver Metastases. Ann Surg Oncol. 2015 Nov;22(12):4038-45. doi: 10.1245/s10434-015-4477-4. Epub 2015 Mar 10.
- Background: PubMed 25788386Wang C, Han J, Xiao L, Jin CE, Li DJ, Yang Z. Efficacy of vasopressin/terlipressin and somatostatin/octreotide for the prevention of early variceal rebleeding after the initial control of bleeding: a systematic review and meta-analysis. Hepatol Int. 2015 Jan;9(1):120-9. doi: 10.1007/s12072-014-9594-9. Epub 2014 Dec 5.
- Background: PubMed 31821652Li JJ, Chao P, Gernsheimer J, Verma R. Octreotide for Gastrointestinal Hemorrhage from Esophageal Varices. Acad Emerg Med. 2020 Apr;27(4):339-340. doi: 10.1111/acem.13901. Epub 2019 Dec 31. No abstract available.
- Background: PubMed 23940908Berreta J, Kociak D, Romero G, Balducci A, Amaya R, Argonz J. [Endoscopic versus endoscopic plus octreotide treatment for acute variceal bleeding. Benefit according to severity at admission]. Acta Gastroenterol Latinoam. 2013 Jun;43(2):89-97. Spanish.
- Byram, S., Gupta, R., Ander, M., Edelstein, S. \& Andreatta, B. (2015). Effects of Continuous Octreotide Infusion on Intraoperative Transfusion Requirements During Orthotopic Liver Transplantation. Transplantation Proceedings, 47(9), 2712-2714.Link provided by the sponsor.
- El Nakeeb, A., ElGawalby, A., A. Ali, MEfficacy of octreotide in the prevention of complications after pancreaticoduodenectomy in patients with soft pancreas and non-dilated panLink provided by the sponsor.
- Terlipressin and the Treatment oLink provided by the sponsor.
- Pisani, A., Sabbatini, M., Imbriaco, M., Riccio, E., Rubis, N., Prinster, A., Perna, A., Liuzzi, R., Spinelli, L., Santangelo, M., Remuzzi, G., Ruggenenti, P., Pisani, A., Sabbatini, M., Ruggenenti, P., Remuzzi, G., Pisani, A., Visciano, B., Amicone, M.,Link provided by the sponsor.
- Somatostatin analogue, Octreotide, improves restraint stress-induced liver injury by ameliorating oxidative stress, inflammatory response, and activation of hepatic stellate cells. Cell Stress and ChaperonesLink provided by the sponsor.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Octreotide in people with Hepatic Carcinoma and Hepatic Metastasis, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence on intraoperative bleeding. (time frame: During the time the surgery lasts.). 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 NCT06085976, which also lists 18 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 17 Oct 2023.