Laparoscopic GastrectomyPhase 2NCT03117283
Laparoscopic Total Gastrectomy With Versus Without Bursectomy
A Phase 2 study testing Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach and Laparoscopic D2 radical total gastrectomy without bursectomy in people with Laparoscopic Gastrectomy and Laparoscopic Bursectomy, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Bursectomy is widely performed in open surgery for advanced gastric cancer in East Asia. However laparoscopic D2 radical total gastrectomy with complete bursectomy is difficult and rare performed. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Gastrectomy, Laparoscopic Bursectomy, A Left Outside Bursa Omentalis Approach
- What is being tested?
- Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach and Laparoscopic D2 radical total gastrectomy without bursectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2017to 1 Apr 2022
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy
- Tumor located in the posterior wall of upper and middle third stomach estimated by endoscopy and CT scan
- Informed consent
- Eastern Cooperative Oncology Group (ECOG): 0 ot 1
- American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ
Who cannot join
- Pregnancy or female in suckling period
- Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- Severe mental disease
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510120
Wei Wang, M.D.,PH.D., +86-13922255515, wangwei16400@163.com
Wenjun Xiong, M.D., +86-15920553177, xiongwj1988@163.com
About this study
Official title: Laparoscopic Total Gastrectomy With Bursectomy in a Left Outside Bursa Omentalis Approach Versus Laparoscopic Total Gastrectomy Without Bursectomy for Advanced Posterior Gastric Wall Cancer: a Randomized Controlled Study
Bursectomy is widely performed in open surgery for advanced gastric cancer in East Asia. However laparoscopic D2 radical total gastrectomy with complete bursectomy is difficult and rare performed. Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left outside bursa omentalis approach for achieving complete bursectomy.
Read the detailed description
Although, the clinical value of bursectomy in addition to D2 lymphadenectomy in radical gastrectomy for curable gastric cancer is controversial. Data analysis of the nationwide registry of gastric cancer in Japanese revealed that 10.7% of patients with subserosal and serosal positive cancer developed peritoneal recurrence after radical gastrectomy. Some trials, although, indicated a biologically reasonable but statistically non-significant advantage to bursectomy. But for patients with posterior gastric wall trans-serosal disease, such micrometastases can constitute the seeds of later recurrence. The non-bursectomy showed worse overall survival. Early removal of micrometastases and cancer cells deposited might prove beneficial and a possible therapeutic effect. In any case, the authors reasonably concluded that bursectomy should not be abandoned at this time. The hypothesis that it might actually enhance survival should be entertained. In the past decades, Japanese, Korea, Chinese and even Turkey, surgeons have continued to performed bursectomy and lymph nodes dissection as the conventional open procedures for advanced gastric cancer. Lymph nodes dissection and bursectomy is routinely regarded as a standard surgical procedure during radical open gastrectomy for tumors penetrating the serosa of the posterior gastric wall. Complete bursectomy and lymphadenectomy in open radical gastrectomy may represents a formidable challenge to the best of surgeons and its influences on operative morbidity and mortality, but it can be also safely performed in high volume experience centers or by experienced surgeons with mortality rate of <1% and morbidity rates around 14%.
Generally speaking, bursectomy is incomplete without total gastrectomy. The concept of bursectomy mentioned above is always almost confined to removal of the local anterior membrane of the transverse mesocolon and pancreatic capsule and to open radical gastrectomy. With the generalization and development of laparoscopic technology, laparoscopic surgery for advanced gastric cancer as clinical study has extensively performed in Asia.The investigators take the lead in carrying out laparoscopic bursectomy and D2 radical gastrectomy by. Herein, the investigators conduct a single-centre randomized controlled trial to explore the safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left outside bursa omentalis approach for achieving complete bursectomy.
- Conditions
- Laparoscopic Gastrectomy, Laparoscopic Bursectomy, A Left Outside Bursa Omentalis Approach
- Being tested
- Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach, Laparoscopic D2 radical total gastrectomy without bursectomy
- Keywords
- Laparoscopic surgery, Radical total gastrectomy, Bursectomy, Advanced posterior gastric wall cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approachProcedure or surgery
Patients with advanced posterior gastric wall cancer including in the laparoscopic total gastrectomy (LTG) with bursectomy group will undergo laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach.
Laparoscopic D2 radical total gastrectomy without bursectomyProcedure or surgery
Patients who are included in the laparoscopic total gastrectomy (LTG) without bursectomy group will undergo laparoscopic D2 radical total gastrectomy without bursectomy in a conventional manner.
| Study group | Role | What they receive |
|---|---|---|
| LTG with Bursectomy | Experimental | laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach Receives: Procedure: Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach |
| LTG without Bursectomy | Sham comparator | laparoscopic D2 radical total gastrectomy without bursectomy Receives: Procedure: Laparoscopic D2 radical total gastrectomy without bursectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early morbidity
The early morbidity is defined as the adverse event observed during peri-operative time.
Measured: 30 days
Secondary outcomes (9)
Operative time
The mean operative time of the procedures
Measured: Intraoperative
Lymph node
This outcome consists of the number of total lymph nodes harvested and the number of lymph nodes in the wall of bursa omentalis
Measured: 14 days
First ambulation
The time to first ambulation
Measured: 30 days
3-year survival
3-year disease free survival rate
Measured: 3 years
5-year survival
5-year overall survival rate
Measured: 5 years
Estimated blood loss
The mean estimated blood loss
Measured: Intraoperative
First flatus
The time to first flatus
Measured: 30 days
First liquid diet
The time to liquid diet
Measured: 30 days
Hospital stay
Postoperative hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start28 Mar 2017
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic GastrectomyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Wei Wang, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese MedicineWenjun Xiong, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117283
- Sponsor's protocol ID
- GDPHCM-GI-02
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data has not been published.
Publications
Hundahl SA. The potential value of bursectomy in operations for trans-serosal gastric adenocarcinoma. Gastric Cancer. 2012 Jan;15(1):3-4. doi: 10.1007/s10120-011-0121-6. No abstract available.
PubMed 22160297Japanese Gastric Cancer Association Registration Committee; Maruyama K, Kaminishi M, Hayashi K, Isobe Y, Honda I, Katai H, Arai K, Kodera Y, Nashimoto A. Gastric cancer treated in 1991 in Japan: data analysis of nationwide registry. Gastric Cancer. 2006;9(2):51-66. doi: 10.1007/s10120-006-0370-y.
PubMed 16767357Fujita J, Kurokawa Y, Sugimoto T, Miyashiro I, Iijima S, Kimura Y, Takiguchi S, Fujiwara Y, Mori M, Doki Y. Survival benefit of bursectomy in patients with resectable gastric cancer: interim analysis results of a randomized controlled trial. Gastric Cancer. 2012 Jan;15(1):42-8. doi: 10.1007/s10120-011-0058-9. Epub 2011 May 15.
PubMed 21573917Imamura H, Kurokawa Y, Kawada J, Tsujinaka T, Takiguchi S, Fujiwara Y, Mori M, Doki Y. Influence of bursectomy on operative morbidity and mortality after radical gastrectomy for gastric cancer: results of a randomized controlled trial. World J Surg. 2011 Mar;35(3):625-30. doi: 10.1007/s00268-010-0914-5.
PubMed 21161652Kayaalp C, Piskin T, Olmez A. Complications of bursectomy after radical gastrectomy for gastric cancer. World J Surg. 2012 Jan;36(1):229; author reply 230. doi: 10.1007/s00268-011-1218-0. No abstract available.
PubMed 21833663Hirao M, Kurokawa Y, Fujita J, Imamura H, Fujiwara Y, Kimura Y, Takiguchi S, Mori M, Doki Y; Osaka University Clinical Research Group for Gastroenterological Study. Long-term outcomes after prophylactic bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial. Surgery. 2015 Jun;157(6):1099-105. doi: 10.1016/j.surg.2014.12.024. Epub 2015 Feb 20.
PubMed 25704429Wang W, Xiong W, Liu Z, Luo L, Zheng Y, Tan P, Diao D, Zou L, Wan J. Clinical significance of No. 10 and 11 lymph nodes posterior to the splenic vessel in D2 radical total gastrectomy: An observational study. Medicine (Baltimore). 2016 Aug;95(32):e4581. doi: 10.1097/MD.0000000000004581.
PubMed 27512888Wang W, Liu Z, Xiong W, Zheng Y, Luo L, Diao D, Wan J. Totally laparoscopic spleen-preserving splenic hilum lymph nodes dissection in radical total gastrectomy: an omnibearing method. Surg Endosc. 2016 May;30(5):2030-5. doi: 10.1007/s00464-015-4438-9. Epub 2015 Jul 23.
PubMed 26201417
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Total Gastrectomy With Bursectomy in a Left Outside Bursa Omentalis Approach Versus Laparoscopic Total Gastrectomy Without Bursectomy for Advanced Posterior Gastric Wall Cancer: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03117283
- Acronym / sponsor ID
- GDPHCM-GI-02
- Conditions
- Laparoscopic Gastrectomy, Laparoscopic Bursectomy, A Left Outside Bursa Omentalis Approach
- Keywords
- Laparoscopic surgery, Radical total gastrectomy, Bursectomy, Advanced posterior gastric wall cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bursectomy is widely performed in open surgery for advanced gastric cancer in East Asia. However laparoscopic D2 radical total gastrectomy with complete bursectomy is difficult and rare performed. Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left outside bursa omentalis approach for achieving complete bursectomy.
Detailed description
Although, the clinical value of bursectomy in addition to D2 lymphadenectomy in radical gastrectomy for curable gastric cancer is controversial. Data analysis of the nationwide registry of gastric cancer in Japanese revealed that 10.7% of patients with subserosal and serosal positive cancer developed peritoneal recurrence after radical gastrectomy. Some trials, although, indicated a biologically reasonable but statistically non-significant advantage to bursectomy. But for patients with posterior gastric wall trans-serosal disease, such micrometastases can constitute the seeds of later recurrence. The non-bursectomy showed worse overall survival. Early removal of micrometastases and cancer cells deposited might prove beneficial and a possible therapeutic effect. In any case, the authors reasonably concluded that bursectomy should not be abandoned at this time. The hypothesis that it might actually enhance survival should be entertained. In the past decades, Japanese, Korea, Chinese and even Turkey, surgeons have continued to performed bursectomy and lymph nodes dissection as the conventional open procedures for advanced gastric cancer. Lymph nodes dissection and bursectomy is routinely regarded as a standard surgical procedure during radical open gastrectomy for tumors penetrating the serosa of the posterior gastric wall. Complete bursectomy and lymphadenectomy in open radical gastrectomy may represents a formidable challenge to the best of surgeons and its influences on operative morbidity and mortality, but it can be also safely performed in high volume experience centers or by experienced surgeons with mortality rate of <1% and morbidity rates around 14%.
Generally speaking, bursectomy is incomplete without total gastrectomy. The concept of bursectomy mentioned above is always almost confined to removal of the local anterior membrane of the transverse mesocolon and pancreatic capsule and to open radical gastrectomy. With the generalization and development of laparoscopic technology, laparoscopic surgery for advanced gastric cancer as clinical study has extensively performed in Asia.The investigators take the lead in carrying out laparoscopic bursectomy and D2 radical gastrectomy by. Herein, the investigators conduct a single-centre randomized controlled trial to explore the safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left outside bursa omentalis approach for achieving complete bursectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTG with Bursectomy | Experimental | Procedure: Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approachlaparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach |
| LTG without Bursectomy | Sham comparator | Procedure: Laparoscopic D2 radical total gastrectomy without bursectomylaparoscopic D2 radical total gastrectomy without bursectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy
- Tumor located in the posterior wall of upper and middle third stomach estimated by endoscopy and CT scan
- Informed consent
- Eastern Cooperative Oncology Group (ECOG): 0 ot 1
- American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ
Key exclusion criteria (4 listed)
- Pregnancy or female in suckling period
- Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- Severe mental disease
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
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 D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approachPatients with advanced posterior gastric wall cancer including in the laparoscopic total gastrectomy (LTG) with bursectomy group will undergo laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach. | Procedure or surgery | LTG with Bursectomy |
| Laparoscopic D2 radical total gastrectomy without bursectomyPatients who are included in the laparoscopic total gastrectomy (LTG) without bursectomy group will undergo laparoscopic D2 radical total gastrectomy without bursectomy in a conventional manner. | Procedure or surgery | LTG without Bursectomy |
Primary outcome
Early morbidity
Time frame: 30 days
The early morbidity is defined as the adverse event observed during peri-operative time.
9 secondary outcomes
Operative time
Time frame: Intraoperative
Lymph node
Time frame: 14 days
First ambulation
Time frame: 30 days
3-year survival
Time frame: 3 years
5-year survival
Time frame: 5 years
Estimated blood loss
Time frame: Intraoperative
First flatus
Time frame: 30 days
First liquid diet
Time frame: 30 days
Hospital stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Results publication: PubMed 22160297Hundahl SA. The potential value of bursectomy in operations for trans-serosal gastric adenocarcinoma. Gastric Cancer. 2012 Jan;15(1):3-4. doi: 10.1007/s10120-011-0121-6. No abstract available.
- Results publication: PubMed 16767357Japanese Gastric Cancer Association Registration Committee; Maruyama K, Kaminishi M, Hayashi K, Isobe Y, Honda I, Katai H, Arai K, Kodera Y, Nashimoto A. Gastric cancer treated in 1991 in Japan: data analysis of nationwide registry. Gastric Cancer. 2006;9(2):51-66. doi: 10.1007/s10120-006-0370-y.
- Results publication: PubMed 21573917Fujita J, Kurokawa Y, Sugimoto T, Miyashiro I, Iijima S, Kimura Y, Takiguchi S, Fujiwara Y, Mori M, Doki Y. Survival benefit of bursectomy in patients with resectable gastric cancer: interim analysis results of a randomized controlled trial. Gastric Cancer. 2012 Jan;15(1):42-8. doi: 10.1007/s10120-011-0058-9. Epub 2011 May 15.
- Results publication: PubMed 21161652Imamura H, Kurokawa Y, Kawada J, Tsujinaka T, Takiguchi S, Fujiwara Y, Mori M, Doki Y. Influence of bursectomy on operative morbidity and mortality after radical gastrectomy for gastric cancer: results of a randomized controlled trial. World J Surg. 2011 Mar;35(3):625-30. doi: 10.1007/s00268-010-0914-5.
- Results publication: PubMed 21833663Kayaalp C, Piskin T, Olmez A. Complications of bursectomy after radical gastrectomy for gastric cancer. World J Surg. 2012 Jan;36(1):229; author reply 230. doi: 10.1007/s00268-011-1218-0. No abstract available.
- Results publication: PubMed 25704429Hirao M, Kurokawa Y, Fujita J, Imamura H, Fujiwara Y, Kimura Y, Takiguchi S, Mori M, Doki Y; Osaka University Clinical Research Group for Gastroenterological Study. Long-term outcomes after prophylactic bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial. Surgery. 2015 Jun;157(6):1099-105. doi: 10.1016/j.surg.2014.12.024. Epub 2015 Feb 20.
- Results publication: PubMed 27512888Wang W, Xiong W, Liu Z, Luo L, Zheng Y, Tan P, Diao D, Zou L, Wan J. Clinical significance of No. 10 and 11 lymph nodes posterior to the splenic vessel in D2 radical total gastrectomy: An observational study. Medicine (Baltimore). 2016 Aug;95(32):e4581. doi: 10.1097/MD.0000000000004581.
- Results publication: PubMed 26201417Wang W, Liu Z, Xiong W, Zheng Y, Luo L, Diao D, Wan J. Totally laparoscopic spleen-preserving splenic hilum lymph nodes dissection in radical total gastrectomy: an omnibearing method. Surg Endosc. 2016 May;30(5):2030-5. doi: 10.1007/s00464-015-4438-9. Epub 2015 Jul 23.
- Individual participant dataSharing planned: No. The data has not been published.
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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.
Wei Wang principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Wenjun Xiong principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach and Laparoscopic D2 radical total gastrectomy without bursectomy in people with Laparoscopic Gastrectomy and Laparoscopic Bursectomy, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 5 inclusion and 4 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 17 Apr 2017. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wang, M.D., PH.D. (+86-13922255515, wangwei16400@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early morbidity (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 NCT03117283, which also lists 8 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 17 Apr 2017.