Gastric CancerCLASS02-01NCT03007550

Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer

A study testing Laparoscopic total gastrectomy and Open total gastrectomy in people with Gastric Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer
What is being tested?: Laparoscopic total gastrectomy and Open total gastrectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 227 participants
Where: 1 siteChina
Study dates: 4 Jan 2017to 24 Oct 2018
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18-75 years；
Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
Clinical stage IA (T1N0M0) or IB (T1N1M0, T2N0M0) (According to AJCC-7th TNM staging system);
Tumor located in the upper or middle third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D1+/D2-10 lymphadenectomy (also apply to multiple primary cancers);
No invasion to Z-line;
BMI (Body Mass Index) < 30 kg/m2;

Show all 13Show fewer

No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
No enlargement of splenic hilar lymph nodes;
Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1;
Preoperative ASA (American Society of Anesthesiologists) scoring: I-III;
Sufficient organ functions;
Written informed consent.

Who cannot join

Preoperative examinations indicate that the stage of the disease is stage II/III/IV;
Preoperative examination indicate enlargement of perigastric or retroperitoneal lymph nodes (min diameter≥1.0cm);
Women during pregnancy or breast-feeding;
Synchronous or metachronous (within 5 years) malignancies;
Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated;
Severe mental disease;

Show all 13Show fewer

Severe respiratory disease;
Severe hepatic and renal dysfunction;
Unstable angina pectoris or history of myocardial infarction within 6 months;
History of cerebral infarction or cerebral hemorrhage within 6 months;
Continuous systemic steroid therapy within 1 month (except for topical use);
Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery;
Patients are participating or have participated in another clinical trial (within 6 months).

Trial locations and contacts

1 site in 1 country.

China1 site

ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Laparoscopic And Open Total Gastrectomy In Patients With Clinical Stage I Gastric Cancer

This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Read the detailed description

Gastric cancer is an important health problem, being the fourth most common cancer and the third leading cause of cancer-related death worldwide. Age standardized mortality rates for gastric cancer are 14.3 per 100 000 in men and 6.9 per 100 000 in women. Incidence shows clear regional and sex variations-rates are highest in Eastern Asia, Eastern Europe, and South America and lowest in Northern and Southern Africa. More than 679 000 new cases and 498,000 deaths occur every year in China, and an increasing trend of proximal gastric cancer is observed during the past years.

More than 20 years after the introduction of laparoscopic gastrectomy, many large-scale randomized controlled trials have been conducted in Japan (JCOG0912 and JLSSG0901), Korea (KLASS01 and KLASS02), and China (CLASS01). These trials are all designed to evaluate the non-inferiority of laparoscopic-assisted distal gastrectomy (LADG) to its open counterpart. No RCT for laparoscopic total gastrectomy (LTG) exists at this moment. The standardization of techniques for esophagojejunal anastomosis in LTG has been difficult even for experienced surgeons.

At present, Japan (JCOG1401), Korea (KLASS03), and Netherlands (STOMACH) have planned or launched clinical studies on LTG. China is one of the countries with the highest incidence of gastric cancer and surgeons have accumulated extensive experience through CLASS01 study. So, it's time for conducting the clinical research on the safety of LTG for gastric cancer.

This CLASS02-01 trial is a prospective, multicenter trial for LTG and open total gastrectomy (OTG) in patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Conditions: Gastric Cancer
Being tested: Laparoscopic total gastrectomy, Open total gastrectomy
Keywords: Gastric cancer, Laparoscopic total gastrectomy, Open total gastrectomy
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laparoscopic total gastrectomyProcedure or surgery
Also called Study group (LTG)
LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
Open total gastrectomyProcedure or surgery
Also called Control group (OTG)
OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma

Study groups in NCT03007550
Study group	Role	What they receive
Laparoscopic total gastrectomy	Experimental	The surgeon will perform LTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group. Receives: Procedure: Laparoscopic total gastrectomy
Open total gastrectomy	Other	The surgeon will perform OTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group. Receives: Procedure: Open total gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Early operative morbidity and mortality rate
The early operative morbidity and mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications and/or death.
Measured: 30 days

Secondary outcomes (2)

Postoperative recovery course
Time to first ambulation, flatus, liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
Measured: 30 days
Postoperative hospital stay
The length of postoperative hospital stay will be recorded.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 201724 Oct 2018

First posted2 Jan 2017 (estimated)
Study start4 Jan 2017
Primary completion24 Oct 2018
Study completion24 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Shanghai Zhongshan HospitalThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 227 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03007550
Sponsor's protocol ID: ZSGC-001
Acronym: CLASS02-01
Status last verified: Feb 2019
First submitted: 22 Dec 2016
Last updated: 20 Feb 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Dindo 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
Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.
PubMed 20160637
Chen K, Xu XW, Zhang RC, Pan Y, Wu D, Mou YP. Systematic review and meta-analysis of laparoscopy-assisted and open total gastrectomy for gastric cancer. World J Gastroenterol. 2013 Aug 28;19(32):5365-76. doi: 10.3748/wjg.v19.i32.5365.
PubMed 23983442
Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01). J Korean Surg Soc. 2013 Feb;84(2):123-30. doi: 10.4174/jkss.2013.84.2.123. Epub 2013 Jan 29.
PubMed 23396494
Nakamura K, Katai H, Mizusawa J, Yoshikawa T, Ando M, Terashima M, Ito S, Takagi M, Takagane A, Ninomiya M, Fukushima N, Sasako M. A phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric Cancer (JCOG0912). Jpn J Clin Oncol. 2013 Mar;43(3):324-7. doi: 10.1093/jjco/hys220. Epub 2012 Dec 28.
PubMed 23275644
Jeong O, Ryu SY, Choi WY, Piao Z, Park YK. Risk factors and learning curve associated with postoperative morbidity of laparoscopic total gastrectomy for gastric carcinoma. Ann Surg Oncol. 2014 Sep;21(9):2994-3001. doi: 10.1245/s10434-014-3666-x. Epub 2014 Apr 1.
PubMed 24687152
Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Song KY, Ryu SY. Long-term results of laparoscopic gastrectomy for gastric cancer: a large-scale case-control and case-matched Korean multicenter study. J Clin Oncol. 2014 Mar 1;32(7):627-33. doi: 10.1200/JCO.2013.48.8551. Epub 2014 Jan 27.
PubMed 24470012
Kim HI, Hur H, Kim YN, Lee HJ, Kim MC, Han SU, Hyung WJ. Standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC): a prospective, observational, multicenter study [NCT01283893]. BMC Cancer. 2014 Mar 19;14:209. doi: 10.1186/1471-2407-14-209.
PubMed 24646327
Villanueva MT. Gastric cancer: a master KLASS in laparoscopic gastrectomy. Nat Rev Clin Oncol. 2014 Mar;11(3):119. doi: 10.1038/nrclinonc.2014.18. Epub 2014 Feb 11. No abstract available.
PubMed 24514147
Wada N, Kurokawa Y, Takiguchi S, Takahashi T, Yamasaki M, Miyata H, Nakajima K, Mori M, Doki Y. Feasibility of laparoscopy-assisted total gastrectomy in patients with clinical stage I gastric cancer. Gastric Cancer. 2014 Jan;17(1):137-40. doi: 10.1007/s10120-013-0235-0. Epub 2013 Feb 22.
PubMed 23430265
Byun C, Han SU. Current status of randomized controlled trials for laparoscopic gastric surgery for gastric cancer in Korea. Asian J Endosc Surg. 2015 May;8(2):130-8. doi: 10.1111/ases.12176. Epub 2015 Mar 5.
PubMed 25753372
Hur H, Lee HY, Lee HJ, Kim MC, Hyung WJ, Park YK, Kim W, Han SU. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial. BMC Cancer. 2015 May 5;15:355. doi: 10.1186/s12885-015-1365-z.
PubMed 25939684
Inaki N, Etoh T, Ohyama T, Uchiyama K, Katada N, Koeda K, Yoshida K, Takagane A, Kojima K, Sakuramoto S, Shiraishi N, Kitano S. A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901). World J Surg. 2015 Nov;39(11):2734-41. doi: 10.1007/s00268-015-3160-z.
PubMed 26170158
Katai H. Current status of a randomized controlled trial examining laparoscopic gastrectomy for gastric cancer in Japan. Asian J Endosc Surg. 2015 May;8(2):125-9. doi: 10.1111/ases.12171. Epub 2015 Feb 10.
PubMed 25676458
Lee JH, Nam BH, Ryu KW, Ryu SY, Park YK, Kim S, Kim YW. Comparison of outcomes after laparoscopy-assisted and open total gastrectomy for early gastric cancer. Br J Surg. 2015 Nov;102(12):1500-5. doi: 10.1002/bjs.9902. Epub 2015 Sep 23.
PubMed 26398912

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Laparoscopic And Open Total Gastrectomy In Patients With Clinical Stage I Gastric Cancer
ClinicalTrials.gov ID: NCT03007550
Acronym / sponsor ID: CLASS02-01 / ZSGC-001
Conditions: Gastric Cancer
Keywords: Gastric cancer, Laparoscopic total gastrectomy, Open total gastrectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 227 participants (actual)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Study start: 4 Jan 2017 (actual)
Primary completion: 24 Oct 2018 (actual)
Study completion: 24 Oct 2018 (actual)
First posted: 2 Jan 2017 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Laparoscopic total gastrectomy	Experimental	Procedure: Laparoscopic total gastrectomyThe surgeon will perform LTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group.
Open total gastrectomy	Other	Procedure: Open total gastrectomyThe surgeon will perform OTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Aged 18-75 years；
Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
Clinical stage IA (T1N0M0) or IB (T1N1M0, T2N0M0) (According to AJCC-7th TNM staging system);
Tumor located in the upper or middle third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D1+/D2-10 lymphadenectomy (also apply to multiple primary cancers);
No invasion to Z-line;

Key exclusion criteria (13 listed)

Preoperative examinations indicate that the stage of the disease is stage II/III/IV;
Preoperative examination indicate enlargement of perigastric or retroperitoneal lymph nodes (min diameter≥1.0cm);
Women during pregnancy or breast-feeding;
Synchronous or metachronous (within 5 years) malignancies;
Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated;

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
Laparoscopic total gastrectomyAlso: Study group (LTG)LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma	Procedure or surgery	Laparoscopic total gastrectomy
Open total gastrectomyAlso: Control group (OTG)OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma	Procedure or surgery	Open total gastrectomy

Primary outcome

Early operative morbidity and mortality rate
Time frame: 30 days
The early operative morbidity and mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications and/or death.

2 secondary outcomes

Postoperative recovery course
Time frame: 30 days
Postoperative hospital stay
Time frame: 30 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
Background: PubMed 15273542Dindo 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.
Background: PubMed 20160637Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.
Background: PubMed 23983442Chen K, Xu XW, Zhang RC, Pan Y, Wu D, Mou YP. Systematic review and meta-analysis of laparoscopy-assisted and open total gastrectomy for gastric cancer. World J Gastroenterol. 2013 Aug 28;19(32):5365-76. doi: 10.3748/wjg.v19.i32.5365.
Background: PubMed 23396494Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01). J Korean Surg Soc. 2013 Feb;84(2):123-30. doi: 10.4174/jkss.2013.84.2.123. Epub 2013 Jan 29.
Background: PubMed 23275644Nakamura K, Katai H, Mizusawa J, Yoshikawa T, Ando M, Terashima M, Ito S, Takagi M, Takagane A, Ninomiya M, Fukushima N, Sasako M. A phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric Cancer (JCOG0912). Jpn J Clin Oncol. 2013 Mar;43(3):324-7. doi: 10.1093/jjco/hys220. Epub 2012 Dec 28.
Background: PubMed 24687152Jeong O, Ryu SY, Choi WY, Piao Z, Park YK. Risk factors and learning curve associated with postoperative morbidity of laparoscopic total gastrectomy for gastric carcinoma. Ann Surg Oncol. 2014 Sep;21(9):2994-3001. doi: 10.1245/s10434-014-3666-x. Epub 2014 Apr 1.
Background: PubMed 24470012Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Song KY, Ryu SY. Long-term results of laparoscopic gastrectomy for gastric cancer: a large-scale case-control and case-matched Korean multicenter study. J Clin Oncol. 2014 Mar 1;32(7):627-33. doi: 10.1200/JCO.2013.48.8551. Epub 2014 Jan 27.
Background: PubMed 24646327Kim HI, Hur H, Kim YN, Lee HJ, Kim MC, Han SU, Hyung WJ. Standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC): a prospective, observational, multicenter study [NCT01283893]. BMC Cancer. 2014 Mar 19;14:209. doi: 10.1186/1471-2407-14-209.
Background: PubMed 24514147Villanueva MT. Gastric cancer: a master KLASS in laparoscopic gastrectomy. Nat Rev Clin Oncol. 2014 Mar;11(3):119. doi: 10.1038/nrclinonc.2014.18. Epub 2014 Feb 11. No abstract available.
Background: PubMed 23430265Wada N, Kurokawa Y, Takiguchi S, Takahashi T, Yamasaki M, Miyata H, Nakajima K, Mori M, Doki Y. Feasibility of laparoscopy-assisted total gastrectomy in patients with clinical stage I gastric cancer. Gastric Cancer. 2014 Jan;17(1):137-40. doi: 10.1007/s10120-013-0235-0. Epub 2013 Feb 22.
Background: PubMed 25753372Byun C, Han SU. Current status of randomized controlled trials for laparoscopic gastric surgery for gastric cancer in Korea. Asian J Endosc Surg. 2015 May;8(2):130-8. doi: 10.1111/ases.12176. Epub 2015 Mar 5.
Background: PubMed 25939684Hur H, Lee HY, Lee HJ, Kim MC, Hyung WJ, Park YK, Kim W, Han SU. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial. BMC Cancer. 2015 May 5;15:355. doi: 10.1186/s12885-015-1365-z.
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.

Yihong Sun, MD principal investigator

Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic total gastrectomy and Open total gastrectomy in people with Gastric Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.

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 13 inclusion and 13 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: finished, as of the sponsor's last update on 20 Feb 2019. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Early operative morbidity and mortality 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 NCT03007550, which also lists 23 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 20 Feb 2019.