Stomach NeoplasmsPhase 3NCT01911832
Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers
A Phase 3 study testing esophagojejunostomy after total gastrectomy, Roux-en-Y gastrojejunostomy after subtotal gastrectomy and wide tube reconstruction after subtotal gastrectomy in people with Stomach Neoplasms and Esophageal Neoplasms, run by West China Hospital at 1 site in China.
Trial summary
The incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, and surgery still remains the optimum therapy. For Siewert's type II and III cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy are regarded as the two main… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms, Esophageal Neoplasms
- What is being tested?
- esophagojejunostomy after total gastrectomy, Roux-en-Y gastrojejunostomy after subtotal gastrectomy and wide tube reconstruction after subtotal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Feb 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically confirmed esophagogastric cancers
- age between 18 to 80 years
- no evidence of metastasis of adjacent organs
- organs function well to tolerate surgery
- no special treatment before surgery
- informed consent was written
Who cannot join
- with other site tumor,simultaneously
- locally recurrent gastric or esophageal cancer
- had a history of malignant tumor within 5 years(except the skin cancer)
- pregnant or lactating women
- there was contraindication for operation
- discovery of metastasis in the operation
- with mental disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China hospital, Sichuan University
Chengdu, Sichuan, 610000
Wang Z qiang, PhD,MD, +8618980602028, wzqtrial@gmail.com
Zhang Y chuan, +8613880412932, 20874185@qq.com
About this study
Official title: Impact of Widths After Gastric Tube Reconstruction on Quality of Life for Patients With Esophagogastric Cancers
The incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, and surgery still remains the optimum therapy. For Siewert's type II and III cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy are regarded as the two main surgical approaches. Esophagojejunostomy after total gastrectomy brings high survival rate and low local recurrence rate which may also induces pulmonary infection or regurgitation. Roux-en-Y gastrojejunostomy after subtotal gastrectomy needs reconstruction of the gastric tube and the width of reconstruction tube was a key factor to predicate prognosis. However, no evidence supplies a comprehensive standard on the width of reconstruction tube which often ranges from 3 cm to 6 cm. Both narrow and wide reconstruction tubes have their own advantages and disadvantages. So the prospective trail recruits patients into three groups: total gastrostomy group (TG group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). And the investigators compare the quality of life using integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom relief as main endpoints.
Read the detailed description
With the decreasing prevalence of gastric cancer, the incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, especially in North America and Europe. Despite the use of chemotherapy, its 5-year survival rate is still low (less than 30%) for cancer of the esophagogastric junction. Surgery still remains the optimum therapy for cancer of the esophagogastric junction. For Siewert's type II and III cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy are regarded as the two main surgical approaches. For quality of life, no prospective trial provides evidence comparing the two approaches.
With a complete clearance of lymph nodes, esophagojejunostomy after total gastrectomy brings high 5-year survival rate, and can decrease the rate of local recurrence. However, due to the whole gastrectomy, the patients often represent bile regurgitation which may induce pulmonary infection, regurgitation asthma and weight loss.
Roux-en-Y gastrojejunostomy after subtotal gastrectomy reserve partial gastric body which was reconstructed into gastric tube. The remaining gastric body still peristalses and functions as well as a stomach. At the same time, the remaining gastric body keeps acid-secreting function which may induce acid regurgitation after surgery.
For Roux-en-Y gastrojejunostomy after subtotal gastrectomy, the width of reconstruction gastric tube was a key factor to predicate prognosis, and it often ranges from 3 cm to 6 cm, without universal standard. Narrow gastric tube may lack enough blood supply, as a result, it increase the rate of anastomotic leakage. On the contrary, wide gastric tube takes up much thoracic capacity which may disturb the normal pulmonary and cardiovascular function. Tabira and his colleagues conduct a prospective trail that proves the width of gastric tube has no relevance to local blood supply, anastomotic leakage and postoperative nutrition, but the study lack enough patients which may increase bias. So, there is no reliable evidence to predict the quality of postoperative life.
The prospective trail recruits patients with of cancer of the esophagogastric junction. And eligible patients were assigned into three groups: total gastrostomy group (TG group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). Quality of life include integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom relief was assessed as primary endpoint. And local recurrence, disease free survival, metastatic rate, overall survival and short-term complication of surgery were also observed as secondary endpoints.
- Conditions
- Stomach Neoplasms, Esophageal Neoplasms
- Being tested
- esophagojejunostomy after total gastrectomy, Roux-en-Y gastrojejunostomy after subtotal gastrectomy, wide tube reconstruction after subtotal gastrectomy, narrow tube reconstruction after subtotal gastrectomy
- Keywords
- Cancer of the esophagogastric junction, Reconstruction of gastric tube, Quality of life, Width, Regurgitation
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagojejunostomy after total gastrectomyProcedure or surgery
Also called total gastrostomy group(TG group)
Roux-en-Y gastrojejunostomy after subtotal gastrectomyProcedure or surgery
Also called subtotal gastrectomy(SG group)
wide tube reconstruction after subtotal gastrectomyProcedure or surgery
Also called wide gastric tube group(WG group)
narrow tube reconstruction after subtotal gastrectomyProcedure or surgery
Also called narrow gastric tube group(NG group)
| Study group | Role | What they receive |
|---|---|---|
| Gastrectomy and subtotal gastrectomy | Experimental | to compare the quality of life between esophagojejunostomy after total gastrectomy(TG group) and Roux-en-Y gastrojejunostomy after subtotal gastrectomy(SG group) Receives: Procedure: esophagojejunostomy after total gastrectomy; Procedure: Roux-en-Y gastrojejunostomy after subtotal gastrectomy |
| Wide and narrow reconstruction tube | Experimental | to compare the quality of life between wide tube reconstruction after subtotal gastrectomy(WG group) and narrow tube reconstruction after subtotal gastrectomy(NG group) in Roux-en-Y gastrojejunostomy Receives: Procedure: wide tube reconstruction after subtotal gastrectomy; Procedure: narrow tube reconstruction after subtotal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
quality of life include: 1)integrated questionnaire of QLQ-STO22 and QLQ-C30. 2)related symptom relief of regurgitation, dysphagia and heartburn et al.
Measured: 3 years
Secondary outcomes (5)
local recurrence
Measured: 1 year
disease free survival
the time from operation to confirmed local recurrence, distant metastases, or death due to disease or treatment, whichever occurred first
Measured: 1 year
metastatic rate
ratio of the patients with metastasis after the operation
Measured: 1 year
overall survival
the fraction of the person from the operation the death,no matter the reason of the death.
Measured: 1 and 3 years
short-term complication of the surgery
complication including pulmonary infection, bleeding and anastomotic leakage et al.
Measured: first 30 day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziqiang Wang,MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911832
- Sponsor's protocol ID
- WqLE-201324
- Status last verified
- Sep 2016
- First submitted
- 22 Jul 2013
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vial M, Grande L, Pera M. Epidemiology of adenocarcinoma of the esophagus, gastric cardia, and upper gastric third. Recent Results Cancer Res. 2010;182:1-17. doi: 10.1007/978-3-540-70579-6_1.
PubMed 20676867Hasegawa S, Yoshikawa T. Adenocarcinoma of the esophagogastric junction: incidence, characteristics, and treatment strategies. Gastric Cancer. 2010 Jun;13(2):63-73. doi: 10.1007/s10120-010-0555-2. Epub 2010 Jul 3.
PubMed 20602191Allum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE. Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer. J Clin Oncol. 2009 Oct 20;27(30):5062-7. doi: 10.1200/JCO.2009.22.2083. Epub 2009 Sep 21.
PubMed 19770374Mariette C, Piessen G, Briez N, Gronnier C, Triboulet JP. Oesophagogastric junction adenocarcinoma: which therapeutic approach? Lancet Oncol. 2011 Mar;12(3):296-305. doi: 10.1016/S1470-2045(10)70125-X. Epub 2010 Nov 23.
PubMed 21109491Johansson J, Djerf P, Oberg S, Zilling T, von Holstein CS, Johnsson F, Walther B. Two different surgical approaches in the treatment of adenocarcinoma at the gastroesophageal junction. World J Surg. 2008 Jun;32(6):1013-20. doi: 10.1007/s00268-008-9470-7.
PubMed 18299921Ielpo B, Pernaute AS, Elia S, Buonomo OC, Valladares LD, Aguirre EP, Petrella G, Garcia AT. Impact of number and site of lymph node invasion on survival of adenocarcinoma of esophagogastric junction. Interact Cardiovasc Thorac Surg. 2010 May;10(5):704-8. doi: 10.1510/icvts.2009.222778. Epub 2010 Feb 13.
PubMed 20154347De Giacomo T, Francioni F, Venuta F, Trentino P, Moretti M, Rendina EA, Coloni GF. Complete mechanical cervical anastomosis using a narrow gastric tube after esophagectomy for cancer. Eur J Cardiothorac Surg. 2004 Nov;26(5):881-4. doi: 10.1016/j.ejcts.2004.07.024.
PubMed 15519175Matsuda T, Kaneda K, Takamatsu M, Takahashi M, Aishin K, Awazu M, Okamoto A, Kawaguchi K. Reliable preparation of the gastric tube for cervical esophagogastrostomy after esophagectomy for esophageal cancer. Am J Surg. 2010 May;199(5):e61-4. doi: 10.1016/j.amjsurg.2009.08.046. Epub 2010 Mar 3.
PubMed 20202621Pierie JP, de Graaf PW, van Vroonhoven TJ, Obertop H. The vascularization of a gastric tube as a substitute for the esophagus is affected by its diameter. Dis Esophagus. 1998 Oct;11(4):231-5. doi: 10.1093/dote/11.4.231.
PubMed 10071804Tabira Y, Sakaguchi T, Kuhara H, Teshima K, Tanaka M, Kawasuji M. The width of a gastric tube has no impact on outcome after esophagectomy. Am J Surg. 2004 Mar;187(3):417-21. doi: 10.1016/j.amjsurg.2003.12.008.
PubMed 15006575
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Widths After Gastric Tube Reconstruction on Quality of Life for Patients With Esophagogastric Cancers
- ClinicalTrials.gov ID
- NCT01911832
- Acronym / sponsor ID
- WqLE-201324
- Conditions
- Stomach Neoplasms, Esophageal Neoplasms
- Keywords
- Cancer of the esophagogastric junction, Reconstruction of gastric tube, Quality of life, Width, Regurgitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 30 Jul 2013 (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.
The incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, and surgery still remains the optimum therapy. For Siewert's type II and III cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy are regarded as the two main surgical approaches. Esophagojejunostomy after total gastrectomy brings high survival rate and low local recurrence rate which may also induces pulmonary infection or regurgitation. Roux-en-Y gastrojejunostomy after subtotal gastrectomy needs reconstruction of the gastric tube and the width of reconstruction tube was a key factor to predicate prognosis. However, no evidence supplies a comprehensive standard on the width of reconstruction tube which often ranges from 3 cm to 6 cm. Both narrow and wide reconstruction tubes have their own advantages and disadvantages. So the prospective trail recruits patients into three groups: total gastrostomy group (TG group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). And the investigators compare the quality of life using integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom relief as main endpoints.
Detailed description
With the decreasing prevalence of gastric cancer, the incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, especially in North America and Europe. Despite the use of chemotherapy, its 5-year survival rate is still low (less than 30%) for cancer of the esophagogastric junction. Surgery still remains the optimum therapy for cancer of the esophagogastric junction. For Siewert's type II and III cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy are regarded as the two main surgical approaches. For quality of life, no prospective trial provides evidence comparing the two approaches.
With a complete clearance of lymph nodes, esophagojejunostomy after total gastrectomy brings high 5-year survival rate, and can decrease the rate of local recurrence. However, due to the whole gastrectomy, the patients often represent bile regurgitation which may induce pulmonary infection, regurgitation asthma and weight loss.
Roux-en-Y gastrojejunostomy after subtotal gastrectomy reserve partial gastric body which was reconstructed into gastric tube. The remaining gastric body still peristalses and functions as well as a stomach. At the same time, the remaining gastric body keeps acid-secreting function which may induce acid regurgitation after surgery.
For Roux-en-Y gastrojejunostomy after subtotal gastrectomy, the width of reconstruction gastric tube was a key factor to predicate prognosis, and it often ranges from 3 cm to 6 cm, without universal standard. Narrow gastric tube may lack enough blood supply, as a result, it increase the rate of anastomotic leakage. On the contrary, wide gastric tube takes up much thoracic capacity which may disturb the normal pulmonary and cardiovascular function. Tabira and his colleagues conduct a prospective trail that proves the width of gastric tube has no relevance to local blood supply, anastomotic leakage and postoperative nutrition, but the study lack enough patients which may increase bias. So, there is no reliable evidence to predict the quality of postoperative life.
The prospective trail recruits patients with of cancer of the esophagogastric junction. And eligible patients were assigned into three groups: total gastrostomy group (TG group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). Quality of life include integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom relief was assessed as primary endpoint. And local recurrence, disease free survival, metastatic rate, overall survival and short-term complication of surgery were also observed as secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrectomy and subtotal gastrectomy | Experimental | Procedure: esophagojejunostomy after total gastrectomy, Procedure: Roux-en-Y gastrojejunostomy after subtotal gastrectomyto compare the quality of life between esophagojejunostomy after total gastrectomy(TG group) and Roux-en-Y gastrojejunostomy after subtotal gastrectomy(SG group) |
| Wide and narrow reconstruction tube | Experimental | Procedure: wide tube reconstruction after subtotal gastrectomy, Procedure: narrow tube reconstruction after subtotal gastrectomyto compare the quality of life between wide tube reconstruction after subtotal gastrectomy(WG group) and narrow tube reconstruction after subtotal gastrectomy(NG group) in Roux-en-Y gastrojejunostomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pathologically confirmed esophagogastric cancers
- age between 18 to 80 years
- no evidence of metastasis of adjacent organs
- organs function well to tolerate surgery
- no special treatment before surgery
Key exclusion criteria (7 listed)
- with other site tumor,simultaneously
- locally recurrent gastric or esophageal cancer
- had a history of malignant tumor within 5 years(except the skin cancer)
- pregnant or lactating women
- there was contraindication for operation
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 |
|---|---|---|
| esophagojejunostomy after total gastrectomyAlso: total gastrostomy group(TG group) | Procedure or surgery | Gastrectomy and subtotal gastrectomy |
| Roux-en-Y gastrojejunostomy after subtotal gastrectomyAlso: subtotal gastrectomy(SG group) | Procedure or surgery | Gastrectomy and subtotal gastrectomy |
| wide tube reconstruction after subtotal gastrectomyAlso: wide gastric tube group(WG group) | Procedure or surgery | Wide and narrow reconstruction tube |
| narrow tube reconstruction after subtotal gastrectomyAlso: narrow gastric tube group(NG group) | Procedure or surgery | Wide and narrow reconstruction tube |
Primary outcome
quality of life
Time frame: 3 years
quality of life include: 1)integrated questionnaire of QLQ-STO22 and QLQ-C30. 2)related symptom relief of regurgitation, dysphagia and heartburn et al.
5 secondary outcomes
local recurrence
Time frame: 1 year
disease free survival
Time frame: 1 year
metastatic rate
Time frame: 1 year
overall survival
Time frame: 1 and 3 years
short-term complication of the surgery
Time frame: first 30 day after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Background: PubMed 20676867Vial M, Grande L, Pera M. Epidemiology of adenocarcinoma of the esophagus, gastric cardia, and upper gastric third. Recent Results Cancer Res. 2010;182:1-17. doi: 10.1007/978-3-540-70579-6_1.
- Background: PubMed 20602191Hasegawa S, Yoshikawa T. Adenocarcinoma of the esophagogastric junction: incidence, characteristics, and treatment strategies. Gastric Cancer. 2010 Jun;13(2):63-73. doi: 10.1007/s10120-010-0555-2. Epub 2010 Jul 3.
- Background: PubMed 19770374Allum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE. Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer. J Clin Oncol. 2009 Oct 20;27(30):5062-7. doi: 10.1200/JCO.2009.22.2083. Epub 2009 Sep 21.
- Background: PubMed 21109491Mariette C, Piessen G, Briez N, Gronnier C, Triboulet JP. Oesophagogastric junction adenocarcinoma: which therapeutic approach? Lancet Oncol. 2011 Mar;12(3):296-305. doi: 10.1016/S1470-2045(10)70125-X. Epub 2010 Nov 23.
- Background: PubMed 18299921Johansson J, Djerf P, Oberg S, Zilling T, von Holstein CS, Johnsson F, Walther B. Two different surgical approaches in the treatment of adenocarcinoma at the gastroesophageal junction. World J Surg. 2008 Jun;32(6):1013-20. doi: 10.1007/s00268-008-9470-7.
- Background: PubMed 20154347Ielpo B, Pernaute AS, Elia S, Buonomo OC, Valladares LD, Aguirre EP, Petrella G, Garcia AT. Impact of number and site of lymph node invasion on survival of adenocarcinoma of esophagogastric junction. Interact Cardiovasc Thorac Surg. 2010 May;10(5):704-8. doi: 10.1510/icvts.2009.222778. Epub 2010 Feb 13.
- Background: PubMed 15519175De Giacomo T, Francioni F, Venuta F, Trentino P, Moretti M, Rendina EA, Coloni GF. Complete mechanical cervical anastomosis using a narrow gastric tube after esophagectomy for cancer. Eur J Cardiothorac Surg. 2004 Nov;26(5):881-4. doi: 10.1016/j.ejcts.2004.07.024.
- Background: PubMed 20202621Matsuda T, Kaneda K, Takamatsu M, Takahashi M, Aishin K, Awazu M, Okamoto A, Kawaguchi K. Reliable preparation of the gastric tube for cervical esophagogastrostomy after esophagectomy for esophageal cancer. Am J Surg. 2010 May;199(5):e61-4. doi: 10.1016/j.amjsurg.2009.08.046. Epub 2010 Mar 3.
- Background: PubMed 10071804Pierie JP, de Graaf PW, van Vroonhoven TJ, Obertop H. The vascularization of a gastric tube as a substitute for the esophagus is affected by its diameter. Dis Esophagus. 1998 Oct;11(4):231-5. doi: 10.1093/dote/11.4.231.
- Background: PubMed 15006575Tabira Y, Sakaguchi T, Kuhara H, Teshima K, Tanaka M, Kawasuji M. The width of a gastric tube has no impact on outcome after esophagectomy. Am J Surg. 2004 Mar;187(3):417-21. doi: 10.1016/j.amjsurg.2003.12.008.
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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 3 study testing esophagojejunostomy after total gastrectomy, Roux-en-Y gastrojejunostomy after subtotal gastrectomy and wide tube reconstruction after subtotal gastrectomy in people with Stomach Neoplasms and Esophageal Neoplasms, run by West China 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 6 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 13 Sep 2016. 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.
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 Wei M tian, M.D. (+8613198596090, m.weihx@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 NCT01911832, which also lists 10 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 13 Sep 2016.