Hepatocellular CarcinomaNCT02009176
Laparoscope Anatomical and Aon-anatomical Hepatectomy
A study testing Laparoscopic Anatomical Hepatectomy and Laparoscopic Aon-anatomical Hepatectomy in people with Hepatocellular Carcinoma, run by Shuguo Zheng, MD at 1 site in China.
Trial summary
The purpose of this study is to compare short-term and long-term efficacy of two surgical methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical method from the pathology and cytology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Laparoscopic Anatomical Hepatectomy and Laparoscopic Aon-anatomical Hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to May 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) both male and female, aged 18 to 70; (2) Hepatocellular carcinoma(HCC)diagnosis is clear preoperative; (3) preoperative liver function evaluation: Child-Pugh => B; (4) the lesions can be anatomical hepatectomy,( Indocyanine Green retention rate of 15 minutes) ICGR-15< 20%, the remaining liver volume is sufficient; (5) hepatic single lesions and tumor size between 3-10 cm, does not Invasion the main vein, hepatic artery and vein and major inferior vena cava, did not occur extrahepatic metastasis, and laparoscopic can complete resection; (6) surgery, radiofrequency ablation (RFA), TACE treatment, radiotherapy and chemotherapy have not been implemented (7) voluntary participation in the study, and informed consent.
Who cannot join
- • (1) age <18 years or> 70 years , pregnant or lactating women; (2) HCC diagnosis is not clear; (3) preoperative liver function evaluation: Child-Pugh C grade; (4) ICGR-15> 20%, the remaining liver volume is insufficient (account for standard liver volume <35%); (5) preoperative tumor has ruptured, or has been undergoing surgery, radiofrequency ablation (RFA), transhepatic arterial chemotherapy and embolization(TACE) or radiotherapy and chemotherapy treatment; (6) preoperative examinations showed multiple (>3)liver lesion or tumor diameter <3 or> 10 cm, a clearly major portal vein, hepatic vein, inferior vena vein tumor thrombus; (7) extrahepatic metastasis; (8) cardio-pulmonary function and other diseases can not tolerate surgery; (9) the patient refused to sign the informed consent form; (10) the tumor has spread and / or lymph node metastasis intraoperative found ; (11) intraoperative found not to be the HCC, such as metastatic hepatic carcinoma, hilar cell carcinoma; (12) Histological examinations showed it is cholangio carcinoma, or mixed liver carcinoma; (13) foreign and Hong Kong, Macao, Taiwan or other areas, estimated that difficult to track, follow-up postoperative
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Shuguo Zheng, Professor, 0086-13508308676, shuguozh@gmail.com
shuguo Zheng, professer
About this study
Official title: The Prospective, Randomized Case-control(RCT) Research of Laparoscope Anatomical and Aon-anatomical Hepatectomy Treat HCC
The purpose of this study is to compare short-term and long-term efficacy of two surgical methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical method from the pathology and cytology.
Read the detailed description
Background:Hepatocellular carcinoma is the world's most common and most malignant tumor, accounting for more than 90% of primary liver cancer, the incidence ranked fifth of malignant tumors in the world. surgery and comprehensive treatment is recognized by the medical profession Surgical approach, including the open HCC hepatectomy and laparoscopic hepatectomy, minimally invasive surgery is the main theme of the 21st century, and laparoscopy as the one of the elements in the field of minimally invasive surgery which carried out more and more in liver surgery, but which one of the two methods to choice to hepatectomy lack of sufficient scientific evidence.The RCT research of laparoscopic anatomical and non-anatomical hepatectomy for HCC has not been reported at home and abroad; Intervention:We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath.Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy
Results:
- operation time, intraoperative blood loss, rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, number of micrometastases ,long-term curative effect and survival time were collected and analysed.
- groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Laparoscopic Anatomical Hepatectomy, Laparoscopic Aon-anatomical Hepatectomy
- Keywords
- Hepatocellular Carcinoma, Laparoscopic, Aon-anatomical hepatectomy, Anatomical hepatectomy, Micrometastases
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Micrometastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Anatomical HepatectomyProcedure or surgery
We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath
Laparoscopic Aon-anatomical HepatectomyProcedure or surgery
We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscop Anatomical Hepatectomy | Experimental | Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound, hepatic segmental staining were used selectively. Receives: Procedure: Laparoscopic Anatomical Hepatectomy |
| Laparoscope Aon-anatomical Hepatectomy | Active comparator | Total laparoscopic aon-anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound or hepatic segmental staining will be used to ensure the tumour was completely resected. Receives: Procedure: Laparoscopic Aon-anatomical Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
follow-up after the surgery every 2 months, to understand relapse, death, statistics 1 year, 3-year and 5-year survival, disease-free survival, recurrence rate.
Measured: 5 years
Secondary outcomes (1)
postoperative complications
hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.
Measured: Duration hospitalization(an expected average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuguo Zheng, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuguo Zheng, MD, Southwest Hospital, China
- Investigators
- Shuguo Zheng, Study director, Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009176
- Sponsor's protocol ID
- SWHZSG003
- Other IDs
- Zhengshuguo
- Status last verified
- Feb 2022
- First submitted
- 8 Dec 2013
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosch FX, Ribes J, Diaz M, Cleries R. Primary liver cancer: worldwide incidence and trends. Gastroenterology. 2004 Nov;127(5 Suppl 1):S5-S16. doi: 10.1053/j.gastro.2004.09.011.
PubMed 15508102Kaido T. Recent randomized controlled trials in hepatectomy. Hepatogastroenterology. 2007 Sep;54(78):1825-30.
PubMed 18019727Man K, Fan ST, Ng IO, Lo CM, Liu CL, Wong J. Prospective evaluation of Pringle maneuver in hepatectomy for liver tumors by a randomized study. Ann Surg. 1997 Dec;226(6):704-11; discussion 711-3. doi: 10.1097/00000658-199712000-00007.
PubMed 9409569Figueras J, Llado L, Ruiz D, Ramos E, Busquets J, Rafecas A, Torras J, Fabregat J. Complete versus selective portal triad clamping for minor liver resections: a prospective randomized trial. Ann Surg. 2005 Apr;241(4):582-90. doi: 10.1097/01.sla.0000157168.26021.b8.
PubMed 15798459Kobayashi A, Miyagawa S, Miwa S, Nakata T. Prognostic impact of anatomical resection on early and late intrahepatic recurrence in patients with hepatocellular carcinoma. J Hepatobiliary Pancreat Surg. 2008;15(5):515-21. doi: 10.1007/s00534-007-1293-7. Epub 2008 Oct 4.
PubMed 18836806Hasegawa K, Kokudo N, Imamura H, Matsuyama Y, Aoki T, Minagawa M, Sano K, Sugawara Y, Takayama T, Makuuchi M. Prognostic impact of anatomic resection for hepatocellular carcinoma. Ann Surg. 2005 Aug;242(2):252-9. doi: 10.1097/01.sla.0000171307.37401.db.
PubMed 16041216Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. doi: 10.1097/00000658-200107000-00010.
PubMed 11420484Zhou XD. Recurrence and metastasis of hepatocellular carcinoma: progress and prospects. Hepatobiliary Pancreat Dis Int. 2002 Feb;1(1):35-41.
PubMed 14607620Hanazaki K, Kajikawa S, Shimozawa N, Matsushita A, Machida T, Shimada K, Yazawa K, Koide N, Adachi W, Amano J. Perioperative blood transfusion and survival following curative hepatic resection for hepatocellular carcinoma. Hepatogastroenterology. 2005 Mar-Apr;52(62):524-9.
PubMed 15816471Man K, Ng KT, Lo CM, Ho JW, Sun BS, Sun CK, Lee TK, Poon RT, Fan ST. Ischemia-reperfusion of small liver remnant promotes liver tumor growth and metastases--activation of cell invasion and migration pathways. Liver Transpl. 2007 Dec;13(12):1669-77. doi: 10.1002/lt.21193.
PubMed 18044786Man K, Lo CM, Xiao JW, Ng KT, Sun BS, Ng IO, Cheng Q, Sun CK, Fan ST. The significance of acute phase small-for-size graft injury on tumor growth and invasiveness after liver transplantation. Ann Surg. 2008 Jun;247(6):1049-57. doi: 10.1097/SLA.0b013e31816ffab6XXX.
PubMed 18520234Liao K, Yang K, Cao L, Lu Y, Zheng B, Li X, Wang X, Li J, Chen J, Zheng S. Laparoscopic Anatomical Versus Non-anatomical hepatectomy in the Treatment of Hepatocellular Carcinoma: A randomised controlled trial. Int J Surg. 2022 Jun;102:106652. doi: 10.1016/j.ijsu.2022.106652. Epub 2022 May 4.
PubMed 35525414
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective, Randomized Case-control(RCT) Research of Laparoscope Anatomical and Aon-anatomical Hepatectomy Treat HCC
- ClinicalTrials.gov ID
- NCT02009176
- Acronym / sponsor ID
- SWHZSG003
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Laparoscopic, Aon-anatomical hepatectomy, Anatomical hepatectomy, Micrometastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shuguo Zheng, MDUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 11 Dec 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 purpose of this study is to compare short-term and long-term efficacy of two surgical methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical method from the pathology and cytology.
Detailed description
Background:Hepatocellular carcinoma is the world's most common and most malignant tumor, accounting for more than 90% of primary liver cancer, the incidence ranked fifth of malignant tumors in the world. surgery and comprehensive treatment is recognized by the medical profession Surgical approach, including the open HCC hepatectomy and laparoscopic hepatectomy, minimally invasive surgery is the main theme of the 21st century, and laparoscopy as the one of the elements in the field of minimally invasive surgery which carried out more and more in liver surgery, but which one of the two methods to choice to hepatectomy lack of sufficient scientific evidence.The RCT research of laparoscopic anatomical and non-anatomical hepatectomy for HCC has not been reported at home and abroad; Intervention:We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath.Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy
Results:
- operation time, intraoperative blood loss, rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, number of micrometastases ,long-term curative effect and survival time were collected and analysed.
- groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscop Anatomical Hepatectomy | Experimental | Procedure: Laparoscopic Anatomical HepatectomyTotal laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound, hepatic segmental staining were used selectively. |
| Laparoscope Aon-anatomical Hepatectomy | Active comparator | Procedure: Laparoscopic Aon-anatomical HepatectomyTotal laparoscopic aon-anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound or hepatic segmental staining will be used to ensure the tumour was completely resected. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) both male and female, aged 18 to 70; (2) Hepatocellular carcinoma(HCC)diagnosis is clear preoperative; (3) preoperative liver function evaluation: Child-Pugh => B; (4) the lesions can be anatomical hepatectomy,( Indocyanine Green retention rate of 15 minutes) ICGR-15< 20%, the remaining liver volume is sufficient; (5) hepatic single lesions and tumor size between 3-10 cm, does not Invasion the main vein, hepatic artery and vein and major inferior vena cava, did not occur extrahepatic metastasis, and laparoscopic can complete resection; (6) surgery, radiofrequency ablation (RFA), TACE treatment, radiotherapy and chemotherapy have not been implemented (7) voluntary participation in the study, and informed consent.
Key exclusion criteria (1 listed)
- • (1) age <18 years or> 70 years , pregnant or lactating women; (2) HCC diagnosis is not clear; (3) preoperative liver function evaluation: Child-Pugh C grade; (4) ICGR-15> 20%, the remaining liver volume is insufficient (account for standard liver volume <35%); (5) preoperative tumor has ruptured, or has been undergoing surgery, radiofrequency ablation (RFA), transhepatic arterial chemotherapy and embolization(TACE) or radiotherapy and chemotherapy treatment; (6) preoperative examinations showed multiple (>3)liver lesion or tumor diameter <3 or> 10 cm, a clearly major portal vein, hepatic vein, inferior vena vein tumor thrombus; (7) extrahepatic metastasis; (8) cardio-pulmonary function and other diseases can not tolerate surgery; (9) the patient refused to sign the informed consent form; (10) the tumor has spread and / or lymph node metastasis intraoperative found ; (11) intraoperative found not to be the HCC, such as metastatic hepatic carcinoma, hilar cell carcinoma; (12) Histological examinations showed it is cholangio carcinoma, or mixed liver carcinoma; (13) foreign and Hong Kong, Macao, Taiwan or other areas, estimated that difficult to track, follow-up postoperative
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 Anatomical HepatectomyWe let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath | Procedure or surgery | Laparoscop Anatomical Hepatectomy |
| Laparoscopic Aon-anatomical HepatectomyWe let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy | Procedure or surgery | Laparoscope Aon-anatomical Hepatectomy |
Primary outcome
Survival rate
Time frame: 5 years
follow-up after the surgery every 2 months, to understand relapse, death, statistics 1 year, 3-year and 5-year survival, disease-free survival, recurrence rate.
1 secondary outcome
postoperative complications
Time frame: Duration hospitalization(an expected average of 7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Background: PubMed 15508102Bosch FX, Ribes J, Diaz M, Cleries R. Primary liver cancer: worldwide incidence and trends. Gastroenterology. 2004 Nov;127(5 Suppl 1):S5-S16. doi: 10.1053/j.gastro.2004.09.011.
- Background: PubMed 18019727Kaido T. Recent randomized controlled trials in hepatectomy. Hepatogastroenterology. 2007 Sep;54(78):1825-30.
- Background: PubMed 9409569Man K, Fan ST, Ng IO, Lo CM, Liu CL, Wong J. Prospective evaluation of Pringle maneuver in hepatectomy for liver tumors by a randomized study. Ann Surg. 1997 Dec;226(6):704-11; discussion 711-3. doi: 10.1097/00000658-199712000-00007.
- Background: PubMed 15798459Figueras J, Llado L, Ruiz D, Ramos E, Busquets J, Rafecas A, Torras J, Fabregat J. Complete versus selective portal triad clamping for minor liver resections: a prospective randomized trial. Ann Surg. 2005 Apr;241(4):582-90. doi: 10.1097/01.sla.0000157168.26021.b8.
- Background: PubMed 18836806Kobayashi A, Miyagawa S, Miwa S, Nakata T. Prognostic impact of anatomical resection on early and late intrahepatic recurrence in patients with hepatocellular carcinoma. J Hepatobiliary Pancreat Surg. 2008;15(5):515-21. doi: 10.1007/s00534-007-1293-7. Epub 2008 Oct 4.
- Background: PubMed 16041216Hasegawa K, Kokudo N, Imamura H, Matsuyama Y, Aoki T, Minagawa M, Sano K, Sugawara Y, Takayama T, Makuuchi M. Prognostic impact of anatomic resection for hepatocellular carcinoma. Ann Surg. 2005 Aug;242(2):252-9. doi: 10.1097/01.sla.0000171307.37401.db.
- Background: PubMed 11420484Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. doi: 10.1097/00000658-200107000-00010.
- Background: PubMed 14607620Zhou XD. Recurrence and metastasis of hepatocellular carcinoma: progress and prospects. Hepatobiliary Pancreat Dis Int. 2002 Feb;1(1):35-41.
- Background: PubMed 15816471Hanazaki K, Kajikawa S, Shimozawa N, Matsushita A, Machida T, Shimada K, Yazawa K, Koide N, Adachi W, Amano J. Perioperative blood transfusion and survival following curative hepatic resection for hepatocellular carcinoma. Hepatogastroenterology. 2005 Mar-Apr;52(62):524-9.
- Background: PubMed 18044786Man K, Ng KT, Lo CM, Ho JW, Sun BS, Sun CK, Lee TK, Poon RT, Fan ST. Ischemia-reperfusion of small liver remnant promotes liver tumor growth and metastases--activation of cell invasion and migration pathways. Liver Transpl. 2007 Dec;13(12):1669-77. doi: 10.1002/lt.21193.
- Background: PubMed 18520234Man K, Lo CM, Xiao JW, Ng KT, Sun BS, Ng IO, Cheng Q, Sun CK, Fan ST. The significance of acute phase small-for-size graft injury on tumor growth and invasiveness after liver transplantation. Ann Surg. 2008 Jun;247(6):1049-57. doi: 10.1097/SLA.0b013e31816ffab6XXX.
- Derived from this study: PubMed 35525414Liao K, Yang K, Cao L, Lu Y, Zheng B, Li X, Wang X, Li J, Chen J, Zheng S. Laparoscopic Anatomical Versus Non-anatomical hepatectomy in the Treatment of Hepatocellular Carcinoma: A randomised controlled trial. Int J Surg. 2022 Jun;102:106652. doi: 10.1016/j.ijsu.2022.106652. Epub 2022 May 4.
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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.
Shuguo Zheng study director
Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical 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 Anatomical Hepatectomy and Laparoscopic Aon-anatomical Hepatectomy in people with Hepatocellular Carcinoma, run by Shuguo Zheng, MD 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 1 inclusion and 1 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 11 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuguo Zheng (0086-13508308676, shuguozh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 5 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 NCT02009176, which also lists 12 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 11 Feb 2022.