Remnant Gastric CancerNCT02792881
The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer
A study testing Laparoscopic completion total gastrectomy with D2 lymphadenectomy in people with Remnant Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
This study aims to investigate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Remnant Gastric Cancer
- What is being tested?
- Laparoscopic completion total gastrectomy with D2 lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years; Carcinomas arise in the remnant stomach following gastrectomy, irrespective of the histology of the primary lesion (benign or malignant) or its risk of recurrence, the extent of resection, or the method of reconstruction; cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 7th Edition; Performance status of 0 or 1 on ECOG scale; ASA class I, II, or III; Written informed consent.
Who cannot join
- Distant metastasis in the preoperative examinations; Previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection); Other malignant diseases (except gastric cancer) within the past 5 years; Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes; Women during breast-feeding or pregnancy; Severe mental disorder; Unstable myocardial infarction, angina, or cerebrovascular accident within the past 6 months; History of continuous systematic administration of corticosteroids within one month; FEV1<50% of predicted values; Requirement of simultaneous surgery for other disease; Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer: A Prospective Trial (FUGES-004)
This study aims to investigate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.
Read the detailed description
In 2005, since Yamada reported the first case of laparoscopic completion total gastrectomy (LCTG) for RGC, laparoscopic technology was widely used in the treatment of RGC. However, due to the low incidence and rapid aggravation of RGC, adhesion, anatomic changes, and more complex lymphatic pathways caused by the previous operation, the popularity of LCTG is limited. Therefore, higher level evidence is warranted to further confirm the safety, feasibility, and oncological outcomes of LCTG in patients with RGC. This prospective single-arm study is designed to evaluate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.
- Conditions
- Remnant Gastric Cancer
- Being tested
- Laparoscopic completion total gastrectomy with D2 lymphadenectomy
- Keywords
- Laparoscopic Completion Total Gastrectomy, Remnant gastric cancer, Feasibility, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic completion total gastrectomy with D2 lymphadenectomyProcedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic completion total gastrectomy with D2 lymphadenectomy will be performed with curative treated intent. For carcinomas arising in the remnant stomach with a gastrojejunostomy, jejunal lymph nodes adjacent to the anastomosis are included as regional lymph nodes. The type of reconstruction will be selected according to the surgeon's experience and the anastomotic procedure will be performed extracorporeally through an auxiliary incision.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Completion Total Gastrectomy Group | Experimental | Patients who underwent laparoscopic completion total gastrectomy with D2 lymphadenectomy will be assigned to this group. Receives: Procedure: Laparoscopic completion total gastrectomy with D2 lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
The early postoperative complication are defined as the event observed within 30 days after surgery.
Measured: 30 days
Secondary outcomes (14)
3-year disease free survival rate
Measured: 36 months
3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Measured: 36 months
Mortality
The early mortality are defined as the event observed within 30 days after surgery.
Measured: 30days
Rates of combined organ resection
Combined organ resection performing by severe injury or abdominal adhesions
Measured: 1 day
Intraoperative morbidity rates
With the number of patients undergoing surgery as the denominator, the number of patients with any of the following intraoperative complications is calculated as numerator.
Measured: 1 day
Number of retrieved lymph nodes
Number of retrieved lymph nodes
Measured: 1 day
Operation time
From skin incision to skin closure
Measured: 1 day
Postoperative recovery course
Including time to first flatus, time to initiation of solid food intake, time to removal of intra-abdominal drains, hospital stay
Measured: 10 days
Intraoperative blood loss
Measured: 1 day
Inflammatory and immune response and nutrional status
the values of hemoglobin, prealbumin, albumin, C-reactive protein, and white blood cell count from peripheral blood before the operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
Textbook Outcome
Textbook outcome (TO) was defined based on review of existing TO metrics in the literature including outcomes such as complete-potentially curative status, no intraoperative complications, no eventful postoperative complications (Clavien-Dindo grade III or higher), 15 lymph nodes(LNs) examined, hospital stay < 21days, no reintervention (surgical, endoscopic or radiological) within 30 days after surgery, no readmission to the intensive care unit (ICU) within 30 days after surgery, no postoperative mortality within 30 days after surgery, and no hospital readmission within 30 days after discharge. When all nine desired health outcomes were realized, TO was achieved.
Measured: 30 days
Technical performance
Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.
Measured: 1 day
The Surgery Task Load Index (SURG-TLX)
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2020
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Remnant Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Changming Huang, M.D.,Ph.D., Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792881
- Sponsor's protocol ID
- FUGES-004
- Status last verified
- Sep 2023
- First submitted
- 26 May 2016
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu D, Zhong Q, Zhang ZQ, Liu SQ, Qiu TY, Chen JY, Jiang YM, Lin GT, Liu ZY, Shang-Guan ZX, Sun YQ, Zheng CH, Li P, Xie JW, Lin JX, Chen QY, Huang CM. Comprehensive comparison of technical performance, surgical outcomes, and oncologic prognosis between remnant gastric cancer and primary upper-third gastric cancer in the era of minimally invasive surgery: A pooled analysis of 3 prospective trials. Surgery. 2025 Jul;183:109395. doi: 10.1016/j.surg.2025.109395. Epub 2025 May 8.
PubMed 40344992Zhong Q, Wu D, Jiang YM, He QL, Dang XY, Xu DB, Sun YQ, Su GQ, Guo KQ, Cai LS, Zhang HX, Ye W, Lin GT, Li P, Xie JW, Chen QY, Zheng CH, Lu J, Huang CM, Lin JX. The safety, feasibility, and oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer: a prospective study with 3-year follow-up (FUGES-004 study). Int J Surg. 2024 Jun 1;110(6):3382-3391. doi: 10.1097/JS9.0000000000001388.
PubMed 38597388
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Feasibility and Oncological Outcomes of Laparoscopic Completion Total Gastrectomy for Remnant Gastric Cancer: A Prospective Trial (FUGES-004)
- ClinicalTrials.gov ID
- NCT02792881
- Acronym / sponsor ID
- FUGES-004
- Conditions
- Remnant Gastric Cancer
- Keywords
- Laparoscopic Completion Total Gastrectomy, Remnant gastric cancer, Feasibility, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 8 Jun 2016 (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.
This study aims to investigate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.
Detailed description
In 2005, since Yamada reported the first case of laparoscopic completion total gastrectomy (LCTG) for RGC, laparoscopic technology was widely used in the treatment of RGC. However, due to the low incidence and rapid aggravation of RGC, adhesion, anatomic changes, and more complex lymphatic pathways caused by the previous operation, the popularity of LCTG is limited. Therefore, higher level evidence is warranted to further confirm the safety, feasibility, and oncological outcomes of LCTG in patients with RGC. This prospective single-arm study is designed to evaluate the safety, feasibility, and long-term oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Completion Total Gastrectomy Group | Experimental | Procedure: Laparoscopic completion total gastrectomy with D2 lymphadenectomyPatients who underwent laparoscopic completion total gastrectomy with D2 lymphadenectomy will be assigned to this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18 and 75 years; Carcinomas arise in the remnant stomach following gastrectomy, irrespective of the histology of the primary lesion (benign or malignant) or its risk of recurrence, the extent of resection, or the method of reconstruction; cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 7th Edition; Performance status of 0 or 1 on ECOG scale; ASA class I, II, or III; Written informed consent.
Key exclusion criteria (1 listed)
- Distant metastasis in the preoperative examinations; Previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection); Other malignant diseases (except gastric cancer) within the past 5 years; Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes; Women during breast-feeding or pregnancy; Severe mental disorder; Unstable myocardial infarction, angina, or cerebrovascular accident within the past 6 months; History of continuous systematic administration of corticosteroids within one month; FEV1<50% of predicted values; Requirement of simultaneous surgery for other disease; Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer.
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 completion total gastrectomy with D2 lymphadenectomyAfter exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic completion total gastrectomy with D2 lymphadenectomy will be performed with curative treated intent. For carcinomas arising in the remnant stomach with a gastrojejunostomy, jejunal lymph nodes adjacent to the anastomosis are included as regional lymph nodes. The type of reconstruction will be selected according to the surgeon's experience and the anastomotic procedure will be performed extracorporeally through an auxiliary incision. | Procedure or surgery | Laparoscopic Completion Total Gastrectomy Group |
Primary outcome
Morbidity
Time frame: 30 days
The early postoperative complication are defined as the event observed within 30 days after surgery.
14 secondary outcomes
3-year disease free survival rate
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Mortality
Time frame: 30days
Rates of combined organ resection
Time frame: 1 day
Intraoperative morbidity rates
Time frame: 1 day
Number of retrieved lymph nodes
Time frame: 1 day
Operation time
Time frame: 1 day
Postoperative recovery course
Time frame: 10 days
Intraoperative blood loss
Time frame: 1 day
Inflammatory and immune response and nutrional status
Time frame: 7 days
Textbook Outcome
Time frame: 30 days
Technical performance
Time frame: 1 day
The Surgery Task Load Index (SURG-TLX)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 40344992Wu D, Zhong Q, Zhang ZQ, Liu SQ, Qiu TY, Chen JY, Jiang YM, Lin GT, Liu ZY, Shang-Guan ZX, Sun YQ, Zheng CH, Li P, Xie JW, Lin JX, Chen QY, Huang CM. Comprehensive comparison of technical performance, surgical outcomes, and oncologic prognosis between remnant gastric cancer and primary upper-third gastric cancer in the era of minimally invasive surgery: A pooled analysis of 3 prospective trials. Surgery. 2025 Jul;183:109395. doi: 10.1016/j.surg.2025.109395. Epub 2025 May 8.
- Derived from this study: PubMed 38597388Zhong Q, Wu D, Jiang YM, He QL, Dang XY, Xu DB, Sun YQ, Su GQ, Guo KQ, Cai LS, Zhang HX, Ye W, Lin GT, Li P, Xie JW, Chen QY, Zheng CH, Lu J, Huang CM, Lin JX. The safety, feasibility, and oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer: a prospective study with 3-year follow-up (FUGES-004 study). Int J Surg. 2024 Jun 1;110(6):3382-3391. doi: 10.1097/JS9.0000000000001388.
Related trials for Remnant Gastric Cancer
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.
Changming Huang, M.D.,Ph.D. study chair
Fujian Medical University Union Hospital
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 completion total gastrectomy with D2 lymphadenectomy in people with Remnant Gastric Cancer, run by Fujian Medical University 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 21 Sep 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 NCT02792881, which also lists 2 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 21 Sep 2023.