Colon CancerICEANCT05039762
Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer
A study testing Extracorporeal anastomosis and Intracorporeal anastomosis in people with Colon Cancer, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
In this study, the investigators will compare extracorporeal anastomosis (EA) with intracorporeal anastomosis (IA) in patients undergoing elective laparoscopic hemicolectomy for right colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Extracorporeal anastomosis and Intracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Sep 2020to 30 Apr 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with right colon cancer
- Eligible for elective laparoscopic right hemicolectomy with primary anastomosis.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- CT staged T1-T3M0 tumour.
Who cannot join
- Pregnancy
- Mental incompetence
- Acute right hemicolectomy before the intended elective surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer - A Prospective Cohort Study
In this study, the investigators will compare extracorporeal anastomosis (EA) with intracorporeal anastomosis (IA) in patients undergoing elective laparoscopic hemicolectomy for right colon cancer.
Read the detailed description
At Odense University Hospital, Svendborg, current standard treatment for right colon cancer is laparoscopic hemicolectomy with extracorporeal anastomosis (EA).
To reduce the risk of adverse events, such as fascial dehiscence and later development of incisional hernia, right hemicolectomy with intracorporeal anastomosis has been introduced.
When performing a laparoscopic right hemicolectomy the dissection is carried out intracorporeally and the transection and anastomosis is made extracorporeally (EA technique). For IA technique the cancer bearing segment is resected and the bowel ends joined intracorporeally with laparoscopic technique, and the specimen is then retrieved through a Pfannenstiel incision.
Previous series have shown shorter hospital stay as well as shorter time to bowel recovery in patients treated with IA compared to EA, without increasing the risk of severe complications or compromising the oncological outcome.
The aim of this study is to investigate whether IA in patients undergoing right hemicolectomy reduces the overall complication rate compared to EA evaluated by Comprehensive Complication Index (CCI) .
51 patients will be enrolled in each group.
- Conditions
- Colon Cancer
- Being tested
- Extracorporeal anastomosis, Intracorporeal anastomosis
- Keywords
- Laparoscopic right hemicolectomy, Intracorporeal anastomosis, Extracorporeal anastomosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal anastomosisProcedure or surgery
Laparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. When the right hemicolon is sufficiently mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated, a horizontal incision in the upper right quadrant is made. Through this incision the right hemicolon is extracted, the small bowel and the transverse colon are divided using staplers. The side-to-side ileocolic anastomosis is then handsewn.
Intracorporeal anastomosisProcedure or surgery
Laparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. The right hemicolon is mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated. The small bowel and the transverse colon are then divided using laparoscopic staplers. The side-to-side ileocolic anastomosis is formed by creating a small opening in the small bowel and the transverse colon, through which the laparoscopic stapler is used to join the bowel ends. The remaining opening is sutured laparoscopically. The specimen is retrieved through a Pfannenstiel incision.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal anastomosis | Active comparator | Laparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer. Receives: Procedure: Extracorporeal anastomosis |
| Intracorporeal anastomosis | Experimental | Laparoscopic right hemicolectomy with Intracorporeal anastomosis in patients with colon cancer. Receives: Procedure: Intracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complication rate
According to the Comprehensive Complication Index (CCI) based on the Clavien Dindo classification of postsurgical complications.
CCI is a continuous scale from 0-100 (0 equals no complications, 100 equals death)
Measured: 30 days
Secondary outcomes (5)
Surgical stress response
Evaluated by C-reactive protein (CRP), leucocytes and National Early Warning Score (NEWS).
NEWS is an aggregate scoring system, based on physiological measurements, designed to help detect acute illness. Minimum score of 0 indicates normal measurements. The score increases with further deviation from the norm, with a maximum score of 20.
Measured: Up to 30 days
Time until bowel recovery
Measured in hours from end of surgery to first flatus and first bowel movement respectively
Measured: Up to 30 days
Length of hospital stay
Measured in hours from end of surgery until the patient is discharged
Measured: Up to 30 days
Postoperative pain
Registered daily using Visual analogue scale (VAS) for pain. The scale ranging from 0-10, 0 being no pain, 10 being worst pain imaginable.
Measured: Up to 30 days
Hernia rate
Based on CT scans 1 and 3 years post surgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start2 Sep 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Prospective, single center, non-randomized, non-blinded
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedicte Schelde-Olesen, University of Southern Denmark
- Investigators
- Benedicte Schelde-Olesen, MD, Principal investigator, Odense University Hospital, Svendborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039762
- Sponsor's protocol ID
- ICEA-051-2016-NQ
- Acronym
- ICEA
- Status last verified
- May 2024
- First submitted
- 11 Nov 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwenk W, Haase O, Neudecker J, Muller JM. Short term benefits for laparoscopic colorectal resection. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003145. doi: 10.1002/14651858.CD003145.pub2.
PubMed 16034888Ricci C, Casadei R, Alagna V, Zani E, Taffurelli G, Pacilio CA, Minni F. A critical and comprehensive systematic review and meta-analysis of studies comparing intracorporeal and extracorporeal anastomosis in laparoscopic right hemicolectomy. Langenbecks Arch Surg. 2017 May;402(3):417-427. doi: 10.1007/s00423-016-1509-x. Epub 2016 Sep 5.
PubMed 27595589Wu Q, Jin C, Hu T, Wei M, Wang Z. Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2017 Apr;27(4):348-357. doi: 10.1089/lap.2016.0485. Epub 2016 Oct 21.
PubMed 27768552van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Jan;31(1):64-77. doi: 10.1007/s00464-016-4982-y. Epub 2016 Jun 10.
PubMed 27287905Vergis AS, Steigerwald SN, Bhojani FD, Sullivan PA, Hardy KM. Laparoscopic right hemicolectomy with intracorporeal versus extracorporeal anastamosis: a comparison of short-term outcomes. Can J Surg. 2015 Feb;58(1):63-8. doi: 10.1503/cjs.001914.
PubMed 25621913Hellan M, Anderson C, Pigazzi A. Extracorporeal versus intracorporeal anastomosis for laparoscopic right hemicolectomy. JSLS. 2009 Jul-Sep;13(3):312-7.
PubMed 19793468Grams J, Tong W, Greenstein AJ, Salky B. Comparison of intracorporeal versus extracorporeal anastomosis in laparoscopic-assisted hemicolectomy. Surg Endosc. 2010 Aug;24(8):1886-91. doi: 10.1007/s00464-009-0865-9. Epub 2010 Jan 29.
PubMed 20112118Milone M, Elmore U, Di Salvo E, Delrio P, Bucci L, Ferulano GP, Napolitano C, Angiolini MR, Bracale U, Clemente M, D'ambra M, Luglio G, Musella M, Pace U, Rosati R, Milone F. Intracorporeal versus extracorporeal anastomosis. Results from a multicentre comparative study on 512 right-sided colorectal cancers. Surg Endosc. 2015 Aug;29(8):2314-20. doi: 10.1007/s00464-014-3950-7. Epub 2014 Nov 21.
PubMed 25414066Emile SH, Elfeki H, Shalaby M, Sakr A, Bassuni M, Christensen P, Wexner SD. Intracorporeal versus extracorporeal anastomosis in minimally invasive right colectomy: an updated systematic review and meta-analysis. Tech Coloproctol. 2019 Nov;23(11):1023-1035. doi: 10.1007/s10151-019-02079-7. Epub 2019 Oct 23.
PubMed 31646396Bollo J, Turrado V, Rabal A, Carrillo E, Gich I, Martinez MC, Hernandez P, Targarona E. Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial). Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17.
PubMed 31846067Mari GM, Crippa J, Costanzi ATM, Pellegrino R, Siracusa C, Berardi V, Maggioni D. Intracorporeal Anastomosis Reduces Surgical Stress Response in Laparoscopic Right Hemicolectomy: A Prospective Randomized Trial. Surg Laparosc Endosc Percutan Tech. 2018 Apr;28(2):77-81. doi: 10.1097/SLE.0000000000000506.
PubMed 29360701Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
PubMed 23728278Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.
PubMed 25379846Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05039762
- Acronym / sponsor ID
- ICEA / ICEA-051-2016-NQ
- Conditions
- Colon Cancer
- Keywords
- Laparoscopic right hemicolectomy, Intracorporeal anastomosis, Extracorporeal anastomosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 10 Sep 2021 (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.
In this study, the investigators will compare extracorporeal anastomosis (EA) with intracorporeal anastomosis (IA) in patients undergoing elective laparoscopic hemicolectomy for right colon cancer.
Detailed description
At Odense University Hospital, Svendborg, current standard treatment for right colon cancer is laparoscopic hemicolectomy with extracorporeal anastomosis (EA).
To reduce the risk of adverse events, such as fascial dehiscence and later development of incisional hernia, right hemicolectomy with intracorporeal anastomosis has been introduced.
When performing a laparoscopic right hemicolectomy the dissection is carried out intracorporeally and the transection and anastomosis is made extracorporeally (EA technique). For IA technique the cancer bearing segment is resected and the bowel ends joined intracorporeally with laparoscopic technique, and the specimen is then retrieved through a Pfannenstiel incision.
Previous series have shown shorter hospital stay as well as shorter time to bowel recovery in patients treated with IA compared to EA, without increasing the risk of severe complications or compromising the oncological outcome.
The aim of this study is to investigate whether IA in patients undergoing right hemicolectomy reduces the overall complication rate compared to EA evaluated by Comprehensive Complication Index (CCI) .
51 patients will be enrolled in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single center, non-randomized, non-blinded
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal anastomosis | Active comparator | Procedure: Extracorporeal anastomosisLaparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer. |
| Intracorporeal anastomosis | Experimental | Procedure: Intracorporeal anastomosisLaparoscopic right hemicolectomy with Intracorporeal anastomosis in patients with colon cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with right colon cancer
- Eligible for elective laparoscopic right hemicolectomy with primary anastomosis.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- CT staged T1-T3M0 tumour.
Key exclusion criteria (3 listed)
- Pregnancy
- Mental incompetence
- Acute right hemicolectomy before the intended elective surgery
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 |
|---|---|---|
| Extracorporeal anastomosisLaparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. When the right hemicolon is sufficiently mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated, a horizontal incision in the upper right quadrant is made. Through this incision the right hemicolon is extracted, the small bowel and the transverse colon are divided using staplers. The side-to-side ileocolic anastomosis is then handsewn. | Procedure or surgery | Extracorporeal anastomosis |
| Intracorporeal anastomosisLaparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. The right hemicolon is mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated. The small bowel and the transverse colon are then divided using laparoscopic staplers. The side-to-side ileocolic anastomosis is formed by creating a small opening in the small bowel and the transverse colon, through which the laparoscopic stapler is used to join the bowel ends. The remaining opening is sutured laparoscopically. The specimen is retrieved through a Pfannenstiel incision. | Procedure or surgery | Intracorporeal anastomosis |
Primary outcome
Overall complication rate
Time frame: 30 days
According to the Comprehensive Complication Index (CCI) based on the Clavien Dindo classification of postsurgical complications. CCI is a continuous scale from 0-100 (0 equals no complications, 100 equals death)
5 secondary outcomes
Surgical stress response
Time frame: Up to 30 days
Time until bowel recovery
Time frame: Up to 30 days
Length of hospital stay
Time frame: Up to 30 days
Postoperative pain
Time frame: Up to 30 days
Hernia rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 16034888Schwenk W, Haase O, Neudecker J, Muller JM. Short term benefits for laparoscopic colorectal resection. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003145. doi: 10.1002/14651858.CD003145.pub2.
- Background: PubMed 27595589Ricci C, Casadei R, Alagna V, Zani E, Taffurelli G, Pacilio CA, Minni F. A critical and comprehensive systematic review and meta-analysis of studies comparing intracorporeal and extracorporeal anastomosis in laparoscopic right hemicolectomy. Langenbecks Arch Surg. 2017 May;402(3):417-427. doi: 10.1007/s00423-016-1509-x. Epub 2016 Sep 5.
- Background: PubMed 27768552Wu Q, Jin C, Hu T, Wei M, Wang Z. Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2017 Apr;27(4):348-357. doi: 10.1089/lap.2016.0485. Epub 2016 Oct 21.
- Background: PubMed 27287905van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Jan;31(1):64-77. doi: 10.1007/s00464-016-4982-y. Epub 2016 Jun 10.
- Background: PubMed 25621913Vergis AS, Steigerwald SN, Bhojani FD, Sullivan PA, Hardy KM. Laparoscopic right hemicolectomy with intracorporeal versus extracorporeal anastamosis: a comparison of short-term outcomes. Can J Surg. 2015 Feb;58(1):63-8. doi: 10.1503/cjs.001914.
- Background: PubMed 19793468Hellan M, Anderson C, Pigazzi A. Extracorporeal versus intracorporeal anastomosis for laparoscopic right hemicolectomy. JSLS. 2009 Jul-Sep;13(3):312-7.
- Background: PubMed 20112118Grams J, Tong W, Greenstein AJ, Salky B. Comparison of intracorporeal versus extracorporeal anastomosis in laparoscopic-assisted hemicolectomy. Surg Endosc. 2010 Aug;24(8):1886-91. doi: 10.1007/s00464-009-0865-9. Epub 2010 Jan 29.
- Background: PubMed 25414066Milone M, Elmore U, Di Salvo E, Delrio P, Bucci L, Ferulano GP, Napolitano C, Angiolini MR, Bracale U, Clemente M, D'ambra M, Luglio G, Musella M, Pace U, Rosati R, Milone F. Intracorporeal versus extracorporeal anastomosis. Results from a multicentre comparative study on 512 right-sided colorectal cancers. Surg Endosc. 2015 Aug;29(8):2314-20. doi: 10.1007/s00464-014-3950-7. Epub 2014 Nov 21.
- Background: PubMed 31646396Emile SH, Elfeki H, Shalaby M, Sakr A, Bassuni M, Christensen P, Wexner SD. Intracorporeal versus extracorporeal anastomosis in minimally invasive right colectomy: an updated systematic review and meta-analysis. Tech Coloproctol. 2019 Nov;23(11):1023-1035. doi: 10.1007/s10151-019-02079-7. Epub 2019 Oct 23.
- Background: PubMed 31846067Bollo J, Turrado V, Rabal A, Carrillo E, Gich I, Martinez MC, Hernandez P, Targarona E. Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial). Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17.
- Background: PubMed 29360701Mari GM, Crippa J, Costanzi ATM, Pellegrino R, Siracusa C, Berardi V, Maggioni D. Intracorporeal Anastomosis Reduces Surgical Stress Response in Laparoscopic Right Hemicolectomy: A Prospective Randomized Trial. Surg Laparosc Endosc Percutan Tech. 2018 Apr;28(2):77-81. doi: 10.1097/SLE.0000000000000506.
- Background: PubMed 23728278Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
- 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. This study is not recruiting at the moment.
Benedicte Schelde-Olesen, MD principal investigator
Odense University Hospital, Svendborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal anastomosis and Intracorporeal anastomosis in people with Colon Cancer, run by University of Southern Denmark 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 4 inclusion and 3 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 8 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complication rate (time frame: 30 days). 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 NCT05039762, which also lists 19 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 8 May 2024.