Gastric CancerPhase 3WCGCC-1202NCT02110628
Roux-en-Y vs. Roux-en-Y+ Pouch for D2 Total Gastrectomy
A Phase 3 study testing Roux-en-Y anastomosis and Roux-en-Y+Pouch anastomosis in people with Gastric Cancer and Roux-en-y Anastomosis Site, run by West China Hospital at 9 sites in China.
Trial summary
Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Roux-en-y Anastomosis Site, Gastric Anastomosis (Site)
- What is being tested?
- Roux-en-Y anastomosis and Roux-en-Y+Pouch anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 9 sitesChina
- Study dates
- Aug 2014to Aug 2022
- Phase
- Phase 3
- 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
- Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of total gastrectomy;
- Predictively resectable diseases, either early or locally advanced gastric cancer, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT1N0M0-T4aN3M0, I-IIIb, except T4b;
- Age: 18-75 years;
- Without serious disease;
- WHO performance score < 2;
- No limit to sexual and race;
- Informed consent required
Who cannot join
- Primary lesion cannot be resected in the pattern of transabdominal total gastrectomy, but for Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
- Patients with other gastric malignant diseases, such as lymphoma and stromal tumors etc.
- Patients suffering from malignant diseases before the study;
- Patients with other severe comorbidities and cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe chronic obstructive pulmonary disease (COPD), chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc.
- Performed emergency operation due to bleeding or perforation;
- Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
- Not the radical surgery, but with tumor residual (R1 or R2).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jian-Kun Hu, M.D.,Ph.D., +8618980601504, hujkwch@126.com
Jian-Kun Hu, M.D.
- Not yet recruiting
Southwest Hospital, the Third Military Medical University
Chongqing, Chongqing Municipality, 404100
Pei-Wu Yu, M.D.,Ph.D.
Pei-Wu Yu, M.D.,Ph.D.
- Not yet recruiting
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 404100
Chao-Jun Zhang, M.D.,Ph.D.
Chao-Jun Zhang, M.D.,Ph.D.
- Not yet recruiting
First Affiliated Hospital of Kunming medical University
Kunming, Yunnan, 650000
Kun-Hua Wang, M.D.
Kun-Hua Wang, M.D.
- Not yet recruiting
First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Quan-Lin Guan, M.D.
Quan-Lin Guan, M.D.
- Not yet recruiting
Union Hospital, Tongji Medical College
Wuhan, Hubei, 430000
Kai-Xiong Tao, M.D.,Ph.D.
Kai-Xiong Tao, M.D.,Ph.D.
- Not yet recruiting
First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Xian, Shanxi, 710000
Xiang-ming Che, M.D.,Ph.D.
Xiang-Ming Che, M.D.,Ph.D.
- Not yet recruiting
Tangdu Hospital, Fourth Military Medical University
Xian, Shanxi, 710000
Xian-Li He, M.D.,Ph.D.
Xian-Li He, M.D.
- Not yet recruiting
Xijing hospital, Fourth Military Medical University
Xian, Shanxi, 710000
Qing-Chuan Zhao, M.D.,Ph.D.
Qing-Chuan Zhao, M.D.,Ph.D.
About this study
Official title: Jejunal Pouch for Postoperative Quality of Life Following Roux-en-Y Reconstruction of Radical Total Gastrectomy: a Multicenter Randomized Controlled Trial (WCGCC-1202)
Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. Nowadays, in order to improve the quality of life, controversies still exist to the reconstruction methods of total gastrectomy. Although roux-en-y anastomosis is the most common method adopted after total gastrectomy for it is an easily and safety method reconstruction method, but some problems still need us to solve, such as little food reserves, less food intake per meal and fast gastric emptying. These problems significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch anastomosis is newly born method can significant increase the volume to improve postoperative quality of life have been proven by some little sample size randomized control trail With the improvement of the gastric cancer surgery, this study proposed by prospective randomized controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of life was evaluated according to the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy.
Read the detailed description
Consecutive patients in each participant units and satisfied with inclusion/exclusion criteria will be informed the details, right, responsibility possible benefit and potential risks when after join in this study. Those patients who agree and sign informed consent document will randomized, consecutive case series sampling.
All the patients in the study and finished sampling would and must be recorded in the Western China Gastric Cancer Collaboration database and assign to corresponding treatment group.
Randomization allocation
After intraoperative exploration and predictively D2 radical (R0) total gastrectomy is possible to be performed, then assigned randomly to each subject on a 1:1 basis to either the Roux-en-Y+Pouch group or the Roux-en-Y group.
Surgical treatment
Surgical approach: open total gastrectomy. Surgical treatment method: Radical total gastrectomy (R0); D2 lymph-node dissection (No.1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 10, 11p, 11d, 12a,19,20); Abscission pneumogastric nerve trunk.
Reconstruction method:
Group A (Roux-en-Y type): closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, esophagojejunal anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm; Group B (Roux-en-Y+Pouch type): closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, pouch reconstruction a J pouch with a length of 15 cm was constructed by connecting the 2 Jejunal lumina, œsophago-P type jejunum Storage bag anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm
Quality control of surgery:
All the surgical treatments will be performed by member of Western China Gastric Cancer Collaboration. Quality supervision within groups to avoid the bias.
Intraoperative photograph after the lymphadenectomy and the reconstruction of the digestive tract is essential.
Follow-up and Database
Follow-up programming:
Postoperative follow-up and assessment will be performed by specially researchers arrange by each units and blind to randomize allocation; Postoperative long term follow-up will be conducted in 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy; Face to face interview is necessary and the postoperative quality of life questionnaire is done by the patients themselves.
Management of the database:
The design of this study database was responsible for the leading units; Each cases of this study should and must have a uniform case reported form, include demographic data, operation data, pathological information and Postoperative quality of life evaluation; A file included in the Case Report Form (CRF) was record follow-up information last to three years after surgery.
Lost follow-up:
Three years lost follow-up rates should below 10%. Lost follow-up rate will reported in final reports, and cases of lost follow-up will take the intention-to-treat (ITT) method to analysis.
Statistics analysis The measurement data strictly obey normal distribution are presented as means (±SD) and compared with single factor analysis of variance.
The measurement data do not obey normal distribution are presented as median and compared with Wilcoxon test.
Categorical data are presented percentage and compared with the Chi-square test.
- Conditions
- Gastric Cancer, Roux-en-y Anastomosis Site, Gastric Anastomosis (Site), Quality of Life, Complication
- Being tested
- Roux-en-Y anastomosis, Roux-en-Y+Pouch anastomosis
- Keywords
- total gastrectomy, pouch, roux-en-y, quality of life
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y anastomosisProcedure or surgery
Roux-en-Y anastomosis
Roux-en-Y+Pouch anastomosisProcedure or surgery
Roux-en-Y+Pouch anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y+Pouch Group | Experimental | Abdominal approach D2 total gastrectomy with Roux-en-Y+Pouch anastomosis. Roux-en-Y+Pouch anastomosis: closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, pouch reconstruction a J pouch with a length of 15 cm was constructed by connecting the 2 Jejunal lumina, œsophago-P type jejunum Storage bag anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm. Receives: Procedure: Roux-en-Y+Pouch anastomosis |
| Roux-en-Y group | Experimental | Abdominal approach D2 total gastrectomy with Roux-en-Y anastomosis. Roux-en-Y anastomosis : closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, œsophago-jejunal anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm Receives: Procedure: Roux-en-Y anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative quality of life
Postoperative quality of life is evaluated by the EORTC QLQ-C30 and the EORTC QLQ-STO22
Measured: 3 years
Secondary outcomes (3)
Intraoperative morbidity and mortality
Measured: Intraoperative
Postoperative morbidity and mortality
Measured: within the first 30 days after surgery
Change of the postoperative body weight
Evaluation the change of the body weigh
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 Apr 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2019 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 West China 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Kun Hu, West China Hospital
- Investigators
- Jian-Kun Hu, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110628
- Sponsor's protocol ID
- WCGCC-1202
- Acronym
- WCGCC-1202
- Status last verified
- Jan 2018
- First submitted
- 7 Apr 2014
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu J, Zhang W, Western China Gastric Cancer Collaboration C. [Experience and present situation of Western China Gastric Cancer Collaboration]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Mar 25;20(3):247-250. Chinese.
PubMed 28338153
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jejunal Pouch for Postoperative Quality of Life Following Roux-en-Y Reconstruction of Radical Total Gastrectomy: a Multicenter Randomized Controlled Trial (WCGCC-1202)
- ClinicalTrials.gov ID
- NCT02110628
- Acronym / sponsor ID
- WCGCC-1202 / WCGCC-1202
- Conditions
- Gastric Cancer, Roux-en-y Anastomosis Site, Gastric Anastomosis (Site), Quality of Life, Complication
- Keywords
- total gastrectomy, pouch, roux-en-y, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 10 Apr 2014 (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.
Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. Nowadays, in order to improve the quality of life, controversies still exist to the reconstruction methods of total gastrectomy. Although roux-en-y anastomosis is the most common method adopted after total gastrectomy for it is an easily and safety method reconstruction method, but some problems still need us to solve, such as little food reserves, less food intake per meal and fast gastric emptying. These problems significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch anastomosis is newly born method can significant increase the volume to improve postoperative quality of life have been proven by some little sample size randomized control trail With the improvement of the gastric cancer surgery, this study proposed by prospective randomized controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of life was evaluated according to the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy.
Detailed description
Consecutive patients in each participant units and satisfied with inclusion/exclusion criteria will be informed the details, right, responsibility possible benefit and potential risks when after join in this study. Those patients who agree and sign informed consent document will randomized, consecutive case series sampling.
All the patients in the study and finished sampling would and must be recorded in the Western China Gastric Cancer Collaboration database and assign to corresponding treatment group.
Randomization allocation
After intraoperative exploration and predictively D2 radical (R0) total gastrectomy is possible to be performed, then assigned randomly to each subject on a 1:1 basis to either the Roux-en-Y+Pouch group or the Roux-en-Y group.
Surgical treatment
Surgical approach: open total gastrectomy. Surgical treatment method: Radical total gastrectomy (R0); D2 lymph-node dissection (No.1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 10, 11p, 11d, 12a,19,20); Abscission pneumogastric nerve trunk.
Reconstruction method:
Group A (Roux-en-Y type): closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, esophagojejunal anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm; Group B (Roux-en-Y+Pouch type): closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, pouch reconstruction a J pouch with a length of 15 cm was constructed by connecting the 2 Jejunal lumina, œsophago-P type jejunum Storage bag anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm
Quality control of surgery:
All the surgical treatments will be performed by member of Western China Gastric Cancer Collaboration. Quality supervision within groups to avoid the bias.
Intraoperative photograph after the lymphadenectomy and the reconstruction of the digestive tract is essential.
Follow-up and Database
Follow-up programming:
Postoperative follow-up and assessment will be performed by specially researchers arrange by each units and blind to randomize allocation; Postoperative long term follow-up will be conducted in 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy; Face to face interview is necessary and the postoperative quality of life questionnaire is done by the patients themselves.
Management of the database:
The design of this study database was responsible for the leading units; Each cases of this study should and must have a uniform case reported form, include demographic data, operation data, pathological information and Postoperative quality of life evaluation; A file included in the Case Report Form (CRF) was record follow-up information last to three years after surgery.
Lost follow-up:
Three years lost follow-up rates should below 10%. Lost follow-up rate will reported in final reports, and cases of lost follow-up will take the intention-to-treat (ITT) method to analysis.
Statistics analysis The measurement data strictly obey normal distribution are presented as means (±SD) and compared with single factor analysis of variance.
The measurement data do not obey normal distribution are presented as median and compared with Wilcoxon test.
Categorical data are presented percentage and compared with the Chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y+Pouch Group | Experimental | Procedure: Roux-en-Y+Pouch anastomosisAbdominal approach D2 total gastrectomy with Roux-en-Y+Pouch anastomosis. Roux-en-Y+Pouch anastomosis: closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, pouch reconstruction a J pouch with a length of 15 cm was constructed by connecting the 2 Jejunal lumina, œsophago-P type jejunum Storage bag anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm. |
| Roux-en-Y group | Experimental | Procedure: Roux-en-Y anastomosisAbdominal approach D2 total gastrectomy with Roux-en-Y anastomosis. Roux-en-Y anastomosis : closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, œsophago-jejunal anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of total gastrectomy;
- Predictively resectable diseases, either early or locally advanced gastric cancer, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT1N0M0-T4aN3M0, I-IIIb, except T4b;
- Age: 18-75 years;
- Without serious disease;
- WHO performance score < 2;
Key exclusion criteria (7 listed)
- Primary lesion cannot be resected in the pattern of transabdominal total gastrectomy, but for Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
- Patients with other gastric malignant diseases, such as lymphoma and stromal tumors etc.
- Patients suffering from malignant diseases before the study;
- Patients with other severe comorbidities and cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe chronic obstructive pulmonary disease (COPD), chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc.
- Performed emergency operation due to bleeding or perforation;
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 |
|---|---|---|
| Roux-en-Y anastomosisRoux-en-Y anastomosis | Procedure or surgery | Roux-en-Y group |
| Roux-en-Y+Pouch anastomosisRoux-en-Y+Pouch anastomosis | Procedure or surgery | Roux-en-Y+Pouch Group |
Primary outcome
Postoperative quality of life
Time frame: 3 years
Postoperative quality of life is evaluated by the EORTC QLQ-C30 and the EORTC QLQ-STO22
3 secondary outcomes
Intraoperative morbidity and mortality
Time frame: Intraoperative
Postoperative morbidity and mortality
Time frame: within the first 30 days after surgery
Change of the postoperative body weight
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 24 Jan 2018.
- Derived from this study: PubMed 28338153Hu J, Zhang W, Western China Gastric Cancer Collaboration C. [Experience and present situation of Western China Gastric Cancer Collaboration]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Mar 25;20(3):247-250. Chinese.
- homepage of West China Hospital, Sichuan UniversityLink 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.
Jian-Kun Hu, M.D. principal investigator
West China Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roux-en-Y anastomosis and Roux-en-Y+Pouch anastomosis in people with Gastric Cancer and Roux-en-y Anastomosis Site, run by West China Hospital at 9 sites 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 7 inclusion and 7 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Jian-Kun Hu, M.D., Ph.D. (+8618980601504 ext. +862885422479, hujkwch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative quality of life (time frame: 3 years). 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 NCT02110628, which also lists 1 linked publication.
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 24 Jan 2018.