Laparoscopic Sentinel Node Navigation Surgery Research Articles

Clinical Efficacy of Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients With Early Gastric Cancer: 5-year Results of the SENORITA Trial.

This study aimed to compare laparoscopic standard gastrectomy (LSG) and laparoscopic sentinel node navigation surgery (LSNNS) for EGC in terms of 5-year long-term oncologic outcomes. The oncological safety of LSNNS for early gastric cancer (EGC) has not been confirmed. Three-year disease-free survival (DFS), which is the primary endpoint of the phase III multicenter randomized controlled clinical trial (SEntinel Node ORIented Tailored Approach [SENORITA] trial), did not show the non-inferiority of LSNNS relative to LSG. The SENORITA trial, a multicenter randomized clinical trial, was designed to show that LSNNS is non-inferior to LSG in terms of 3-year DFS. In the present study, we collected 5-year follow-up data from 527 patients recruited in the SENORITA trial as the full analysis set (FAS). Disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and recurrence patterns were evaluated using the FAS of both LSG (n=269) and LSNNS (n=258). The 5-year DFS was not significantly different between the LSG and LSNNS groups (P=0.0561). During the 5-year follow-up, gastric cancer-related events, such as metachronous cancer, were more frequent in the LSNNS group than in the LSG group. However, ten recurrent cancers in the remnant stomach of both groups were curatively resected by additional gastrectomy and one by additional endoscopic resection. Two of the 198 patients who underwent local resection for stomach preservation based on the LSNNS results developed distant metastasis. However, there was no statistically significant difference in the 5-year OS and DSS (P=0.7403 and P=0.9586, respectively) between the two groups. The 5-year DFS, DSS and OS did not differ significantly between the two groups. Considering the benefits of LSNNS on postoperative quality of life, LSNNS could be recommended as an alternative treatment option for EGC.

Long-term quality of life and nutritional results of stomach-preserving surgery after sentinel node evaluation in patients with early gastric cancer: A multicenter, randomized phase 3 trial (SENORITA).

4070 Background: In the SENORITA trial, laparoscopic sentinel node navigation surgery (LSNNS) showed no significant difference in overall and disease specific survivals compared with laparoscopic standard gastrectomy (LSG). Here, we present the effect of stomach preservation surgery on QoL and nutritional outcomes, and identify risk factors affecting QoL in stomach preservation surgery. Methods: SENORITA was a prospective multicenter randomized trial. Patients diagnosed with early gastric cancer of 3 cm or less were randomly allocated (1:1) to LSNNS or LSG. The primary endpoint was 3-year disease-free survival. This analysis focuses on long-term quality of life and nutritional outcomes of patients who finally underwent stomach-preservation surgery in the LSNNS group. QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) at 3, 12, 24, and 36 months after surgery. Linear mixed model analyses were used to evaluate differences between treatment groups. This trial is registered with ClinicalTrials.gov, NCT01804998. Results: From March 2013 to March 2017, a total of 580 patients were randomly assigned in the SENROTA trial. Among them, 258 patients underwent sentinel node navigation surgery and 198 finally underwent stomach preservation surgery. QoL data was available in 194 patients and compared with those of 257 patients who underwent standard gastrectomy. The stomach-preservation group had better QoL in physical function, dyspnea, and appetite loss of C30 and dysphagia, pain, reflux symptoms, eating restriction, anxiety, taste change, body image, and total score of STO22. Regarding nutritional outcomes, body mass index, hemoglobin, protein, and albumin levels were significantly higher in the stomach-preservation group than in the gastrectomy group. In multivariate analyses, tumor location (greater curvature) was an independent favorable factor affecting global health status, reflux symptoms, eating restriction, and total score of STO22 at 3 months in the stomach-preservation group. Segmental resection was a risk factor for diarrhea and eating restriction at postoperative 3 year. Conclusions: The stomach-preservation surgery had better long-term QoL and nutritional outcomes compared with standard gastrectomy. These findings can help decision making about treatment for patients with early gastric cancer, especially or elderly or nutritionally high risk patients. Clinical trial information: NCT01804998 .

Recent Advances in Sentinel Node Navigation Surgery for Early Gastric Cancer

Maintaining the postoperative quality of life (QOL) while ensuring curability without overtreatment is important in the treatment of early gastric cancer. Postoperative QOL is anticipated to be maintained through minimally invasive function-preserving gastrectomy in early gastric cancer. The concept of the sentinel lymph node (SN) basin is essential to maintain the curability of early gastric cancer using minimally invasive function-preserving gastrectomy. However, additional resection after surgery is difficult to perform in gastric cancer. Thus, the SN basin theory is important. Recently, a multicenter randomized phase III trial in South Korea (SENORITA trial) proved that laparoscopic sentinel node navigation surgery (LSNNS) for stomach preservation results in better postoperative QOL compared with standard gastrectomy in patients with early gastric cancer. LSNNS contributes to patients' QOL based on the concept that curability is not impaired. A multicenter nonrandomized phase III trial is ongoing in Japan, and oncologic safety is expected to be demonstrated. LSNNS has been established as a treatment option for selected patients with early gastric cancer, and its application will become widespread in the future.

Clinical efficacy of laparoscopic sentinel node navigation surgery for early gastric cancer: Five-year results of SENORITA trial.

4050 Background: A phase III multicenter randomized controlled clinical trial (SEntinel Node ORIented Tailored Approach [SENORITA] trial) has been performed to confirm the oncologic safety of laparoscopic sentinel node navigation surgery (LSNNS) for early gastric cancer (EGC). The results did not show the non-inferiority of LSNNS relative to laparoscopic standard gastrectomy (LSG) in terms of 3-year disease-free survival (DFS), the primary endpoint of the SENORITA trial even though the improved quality of life (QOL) in the LSNNS group. However, the long-term oncologic outcomes of LSNNS have not been compared with conventional surgery. This study was planned to investigate the comparison of LSG and LSNNS for EGC in terms of 5 years survival. Methods: We collected 5-year follow-up data of 527 patients recruited in the SENORITA trial. The overall survival (OS), disease-free survival (DFS), and recurrence pattern were evaluated in full analysis sets of both LSG (n = 269) and LSNNS (n = 258). Results: The mean follow-up period was 58.5 and 57.7 months in LSNNS and LSG groups. There was no statistically significant difference in 5-year OS (p = 0.7403) and DFS (p = 0.0561) between LSG and LSNNS. In terms of DFS, additional five events in the LSG group and 7 in LSNNS occurred after a 3-year follow-up until 5-years. Primary site recurrence in 1 LSNNS, and metachronous gastric cancer occurred in one LSG and two in LSNNS were diagnosed from 3 to 5-year follow-up period. Other organ cancer developed in two vs. three and other deaths occurred in two v s. one in each group, respectively, from 3 to 5-year follow-up. Overall survival events were 6 in LSG and 7 in LSNNS, and disease-specific death events were two patients in both groups until five years. Conclusions: Although the SENORITA trial did not show non-inferiority of LSNNS in the primary endpoint, 3-year DFS relative to LSG, the 5-year DFS and OS did not reveal the statistical difference between the two groups. Considering the benefit of LSNNS regarding the postoperative QOL, LSNNS could be recommended as an alternative treatment option of LSG for EGC. Clinical trial information: NCT01804998.

[Laparoscopic sentinel node navigation surgery in gastric cancer to reduce surgical radicality].

[Laparoscopic sentinel node navigation surgery in gastric cancer to reduce surgical radicality].

Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients With Early Gastric Cancer: A Randomized Clinical Trial.

PURPOSETo compare postoperative complications, long-term survival, and quality of life (QOL) after laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG).METHODSFive hundred eighty patients with preoperatively diagnosed stage IA gastric adenocarcinoma (≤ 3 cm) were assigned to undergo either LSG or LSNNS. Observers were not blinded to patient grouping. The primary outcome was 3-year disease-free survival (3y-DFS). Secondary outcomes included postoperative complications, QOL, 3-year disease-specific survival (3y-DSS), and 3-year overall survival (3y-OS).RESULTSIn total, 527 patients were included in the modified intention-to-treat analysis population for the primary outcome (LSG, 269; LSNNS, 258). Stomach-preserving surgery was performed in 210 patients (81%) in the LSNNS group. During the median follow-up duration, the 3y-DFS rates in the LSG and LSNNS groups were 95.5% and 91.8%, respectively (difference: 3.7%; 95% CI, –0.6 to 8.1). Three patients with recurrence and five with metachronous gastric cancer in the LSNNS group underwent standard surgery. Two patients with distant metastasis in both groups were treated with palliative chemotherapy. The 3y-DSS and 3y-OS rates in the LSG and LSNNS groups were 99.5% and 99.1% (P = .59) and 99.2% and 97.6% (P = .17), respectively. Postoperative complications occurred in 19.0% of the LSG group and 15.5% of the LSNNS group (P = .294). The LSNNS group showed better physical function (P = .015), less symptoms (P < .001), and improved nutrition than the LSG group.CONCLUSIONLSNNS did not show noninferiority to LSG for 3y-DFS, with a 5% margin. However, the 3y-DSS and 3y-OS were not different after rescue surgery in cases of recurrence/metachronous gastric cancer, and LSNNS had better long-term QOL and nutrition than LSG.

Long-term quality of life and nutritional results after laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy for early gastric cancer: Secondary outcomes of a multicenter, randomized phase 3 trial (SENORITA).

4054 Background: Laparoscopic sentinel node navigation surgery (LSNNS) has been suggested as an alternative to laparoscopic standard gastrectomy (LSG) in early gastric cancer patients to improve long-term quality of life (QOL) and nutritional outcomes. Here, we present 3-year results of patient-reported quality of life (QOL) and nutrition, secondary endpoints of SENORITA trial. Methods: SENORITA is a prospective multicenter randomized phase 3 trial. Patients diagnosed with early gastric cancer of 3 cm or less were randomly allocated (1:1) to LSNNS for stomach preservation or LSG. The primary endpoint was 3-year disease-free survival. In this study, we analyzed QOL assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC stomach module (STO22) and nutritional parameters at 3, 12, 24, and 36 months after surgery. Linear mixed model analyses was used to evaluate differences between the two groups. This trial is registered with ClinicalTrials.gov, NCT01804998. Results: From March 2013 to March 2017, a total of 580 patients were randomly assigned and 527 patients were included in the modified intention-to-treat analysis population (258 in LSNNS and 269 in LSG group). QOL questionnaires were available for 99.4% of patients at baseline and then for 92.2%, 83.2%, 72.8%, and 66.9% at 3, 12, 24, and 36 months after surgery, respectively. The LSNNS group had higher physical function score than the LSG group at all time points (p = 0.002). However, there were no significant differences in other scales of EORTC QLQ-C30. Regarding EORTC QLQ-STO22, pain, eating restriction, anxiety, and taste scores were lower (better QOL) at all time points in the LSNNS group than in the LSG group (p = 0.002, &lt; 0.001, &lt; 0.001, and &lt; 0.001, respectively). The summary score of EORTC QLQ-STO22 was also higher in the LSNNS group representing better QOL (p &lt; 0.001). Body mass index, hemoglobin and total protein were significantly higher in the LSNNS group compared with the LSG group. Conclusions: The LSNNS group had better physical function and less symptoms, including pain, eating restriction, anxiety, and taste change compared with the LSG group. Moreover, the nutritional parameters were better maintained in the LSNNS group than in the LSG group. These findings showed benefits of stomach preserving surgery in LSNNS and can be used to help decision making about treatment for patients with early gastric cancer. Clinical trial information: NCT01804998.

Quality of life after laparoscopic sentinel node navigation surgery in early gastric cancer: a single-center cohort study.

To investigate the quality of life (QOL) of patients after laparoscopic sentinel node navigation surgery (SNNS) compared to conventional laparoscopy-assisted distal gastrectomy (LADG) in early gastric cancer patients. Patients recruited for laparoscopic SNNS surgery between July 2010 and April 2013 were assessed for their QOL. A historical control group was established, consisting of patients who underwent conventional LADG with radical lymphadenectomy from the same institution. QOL questionnaire was taken serially from preoperative week 1 until 12months postoperatively (1, 3, 6, and 12months) using the Korean version of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire-core (QLQ-C30) and gastric cancer-specific questionnaire (STO22). A total of 80 prospectively gathered patients who received SNNS were categorized into the comparison group (SNNS group). The QOL was compared with 78 patients identified to have received LADG from the gastric cancer database of our institution and were sorted into the control group (LADG group). In QLQ-C30, SNNS group showed better functioning scales in all except role functioning and better scores from the symptom scales in fatigue, insomnia, and diarrhea compared to the LADG group. In QLQ-STO22, scores on dysphagia, eating restriction, anxiety, and body image disturbance were better in SNNS group. Postoperative QOL in laparoscopic gastrectomy combined with SNNS is superior compared to conventional laparoscopic distal gastrectomy in patients with stage I gastric cancer.

Laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer: Final three-year survival results of multicenter randomized controlled phase III trial (SENORITA trial).

4510 Background: The benefits and hazards of laparoscopic sentinel node navigation surgery (LSNNS), compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection in early gastric cancer (EGC), are unknown. The SENORITA trial investigated the clinical impact of LSNNS in EGC in terms of short-term surgical outcomes, long-term survival and quality of life. Methods: This study is a prospective, multicenter, randomized controlled, non-inferiority trial. Patients with preoperatively diagnosed gastric adenocarcinoma with T1N0 of 3 cm or less in diameter, regardless of histology, except absolute indication for endoscopic resection were eligible. Patients were randomized to LSG or LSNNS using dual tracers. The primary endpoint is 3-year disease-free survival (3yDFS). Planned sample size per arm is 290 patients with the non-inferiority margin of 2.737 in hazard ratio (HR) assuming that LSG achieve 97% 3yDFS, 5% of type 1 error and 80% of power. Three-year recurrence-free survival (3yRFS), overall survival (3yOS) and disease specific death rate (3yDSDR) were evaluated as secondary endpoints. Results: From March 2013 to December 2016, 580 patients were randomized (LSG arm 292 vs. LSNNS arm 288). After 53 patients dropped out before surgery, operation was performed in 527 patients (269 vs. 258), representing the full analysis set. LSG was performed in 266 according to the protocol excluding 3 open conversion. After exclusion of 13 without LSNNS due to various reasons, LSNNS was performed in 245 patients according to the protocol. After median follow up of 47.5 months, 3yDFS were 95.5% and 91.8% (HR 1.901, CI 0.911 – 3.967), respectively. The 3yRFS was 98.9% and 95.2% (p=0.019), and 3yOS was 99.2% and 97.6% (p=0.166), and 3yDSDR was 99.5% and 99.1% (p=0.591), respectively. Conclusion: LSNNS in EGC did not show non-inferiority compared with LSG in terms of 3yDFS. However, 3yOS and 3yDSDR of LSNNS were comparable to LSG by the rescue surgery of recurrence. LSNNS might be an alternative surgical option instead of LSG in selected EGC patients. Clinical trial information: NCT01804998 .

Laparoscopic Sentinel Node Navigation Surgery Versus Laparoscopic Standard Gastrectomy with Lymph Node Dissection for Early Gastric Cancer: Postoperative Morbidity and Mortality Results of Prospective Multicenter Phase III Trial (SENORITA)

Background: Risks and benefits of laparoscopic sentinel node navigation surgery (LSNNS) compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection (LND) for early gastric cancer (EGC) are unknown. The SENORITA trial investigated the clinical impact of LSNNS for EGC regarding short-term surgical outcomes, long-term survival, and quality of life (QOL). Methods: Patients with preoperatively diagnosed T1N0 gastric adenocarcinoma with a diameter of 3 cm or smaller regardless of histology (except absolute indication for endoscopic resection) were eligible. Patients were randomized to LSG with LND or LSNNS. The primary endpoint was 3-year disease-free survival. Morbidity and mortality within 30 postoperative days were evaluated as secondary endpoints and graded by the Clavien-Dindo classification. Findings: From March 2013 to December 2016, 580 patients were randomized (LSG, 292; LSNNS, 288). Fifty-three patients dropped out before surgery due to various reasons. Surgery was performed for 527 patients (LSG, 269; LSNNS, 258) representing the full analysis set. LSNNS was not performed in 13 patients due to intraoperative findings. LSNNS was performed according to protocol for 245 patients, and detection of sentinel basin was possible for 237 patients (96.7%, 237/245). Stomach-preserving surgery was performed in 210 patients (81.4%. 210/258). Postoperative complications occurred in 51 LSG patients (19.0%) and 40 LSNNS patients (15.5%) (P=0.294). Clavien-Dindo grade III or higher complications occurred in 16 LSG patients (5.9%) and 13 LSNNS patients (5.0%) (P=0.647). Postoperative mortality occurred in one LSG patient. LSNNS was not a risk factor for postoperative morbidity in multivariate analysis except sex. Interpretation: LSNNS for EGC is a safe procedure in terms of postoperative morbidity and mortality when compared with LSG with LND. Results: From March 2013 to December 2016, 580 patients were randomized (LSG, 292; LSNNS, 288). Surgery was performed for 527 patients (LSG, 269; LSNNS, 258) representing the full analysis set. LSNNS was not performed in 13 patients due to intraoperative findings. LSNNS was performed according to protocol for 245 patients, and detection of sentinel basin was possible for 237 patients (96.7%, 237/245). Stomach-preserving surgery was performed in 210 patients (81.4%. 210/258). Postoperative complications occurred in 51 LSG patients (19.0%) and 40 LSNNS patients (15.5%) (P=0.294). Clavien-Dindo grade III or higher complications occurred in 16 LSG patients (5.9%) and 13 LSNNS patients (5.0%) (P=0.647). Postoperative mortality occurred in one LSG patient. LSNNS was not a risk factor for postoperative morbidity in multivariate analysis except sex. Conclusions: LSNNS for EGC is a safe procedure in terms of postoperative morbidity and mortality when compared with LSG with LND. Trial Registration Number: NCT01804998. Funding: National Cancer Center, Republic of Korea (grant number: 1710160-2). Declaration of Interest: The authors declare that they have no conflicts of interest or financial ties to disclose. Ethical Approval: All patients provided written informed consent before the surgery. This study was reviewed and approved by the local institutional review boards of all participating institutions.

Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol.

PurposeAlthough standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD.Materials and MethodsThis trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications.ConclusionsThis study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.Trial RegistrationClinicalTrials.gov Identifier: NCT03123042

Laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer: Results of postoperative morbidity and mortality from a multicenter randomized controlled trial (SENORITA trial).

e16043Background: The benefits and hazards of laparoscopic sentinel node navigation surgery (LSNNS), compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection (LND) in early ...

Laparoscopic sentinel node navigation surgery for early gastric cancer

Currently, the most accurate method for identifying lymph node metastasis is intraoperative diagnosis by sentinel node (SN) biopsy. Based on the SNNS study-a recent large-scale, nationwide, multicenter prospective study-the SN concept seems to be scientifically valid in patients with early gastric cancer. SN biopsy is a multistep technique consisted of six essential elements: indication, the selection of a tracer, a proper tracer injection method, the objective detection of SNs, a reliable biopsy technique, and the precise detection of nodal metastasis. For SN biopsy of gastric cancer, these elements have been validated as follows: the indication should be limited to clinical T1 less than 4 cm in diameter; combination mapping with radioactive colloid and blue dye is used as the standard; and endoscopic submucosal injection is the standard tracer injection. Detection of SNs and a reliable biopsy technique are enabled by adaptation of lymphatic basin dissection, a proper biopsy technique for gastric cancer. Lymphatic basin dissection is a selective lymphadenectomy procedure for dissecting basins en bloc, collecting lymph nodes and lymphatic vessels stained with dye. Lymphatic basin dissection is superior to the ordinary pick-up method, not only for minimizing the rate of missed SNs, but also in terms of oncological safety as it complements an intraoperative frozen section diagnosis by serving as a backup dissection. Moreover, indocyanine green (ICG) fluorescence mapping has been developed in recent years. ICG fluorescence mapping is superior because of its high sensitivity and signal stability. Moreover, it is feasible for both open and laparoscopic gastrectomy in treating early gastric cancer. SN biopsy has brought dramatic changes to laparoscopic surgery for early gastric cancer. With laparoscopic SN biopsy using ICG fluorescence navigation, laparoscopic surgery for early gastric cancer has changed from the uniform standard gastrectomy with D1+ into a tailor-made function-preserving surgical procedure, such as local resection with lymphatic basin dissection.

Phase II, prospective, single-arm, single-institutional, open-label clinical trial on laparoscopic sentinel node navigation surgery in early gastric cancer.

90 Background: The aim of this study was to evaluate the feasibility and safety of laparoscopic limited gastrectomy with sentinel basin (SB) dissection for gastric cancer using simultaneous indocyanine green and 99mTc-antimony sulfur colloid injections. Methods: The primary end point was the 3-year relapse-free survival rate of the patients who underwent laparoscopic sentinel node navigation surgery (SNNS). Secondary end points included sentinel node (SN) detection rate, false negative rate of intraoperative pathologic examinations for metastatic SN detection, postoperative morbidity and mortality, quality of life (QOL), and overall survival. Results: From July 2010 to April 2013, 100 patients were enrolled to this study. The SBs were identified in all patients (100%) by dual method. The mean number of SN and non-SN was 6.07 ± 3.84 [range 0-17] and 4.60 ± 4.76 [range 0-25]. Eleven patients had SN metastasis and they were converted to conventional laparoscopic gastrectomy with radical lymphadenectomy. Among 89 patients with negative SNs, 3 patients were considered as false negative of intraoperative pathological examination (3.37%). There was no significant difference between SN negative (n = 89) and positive (n = 11) groups in estimated blood loss, postoperative hospital stays and complication rate. Overall, QOL scores are more likely to be better in SNNS group than in conventional laparoscopic distal gastrectomy group. After median follow-up periods of 47.5 months in all patients, 4 patients who underwent SNNS died, and 2 patients who underwent SNNS had recurrences of cancer. The 3-year relapse-free survival rate for all patients (n = 100) was 97.0 %. In the subgroup analysis, the 3-year relapse-free for the SN negative group was 96.6%, and 100% for the SN positive group (P = 0.374). The 3-year overall survival rate was 98.0% for all patients; 97.7% for the SN negative group and 100% for the SN positive group (P = 0.418). Conclusions: Laparoscopic SNNS was feasible and safe in early gastric cancer. Phase III randomized controlled trial on comparing laparoscopic SNNS and conventional laparoscopic gastrectomy will be needed based on the present study. Clinical trial information: NCT01441310.

Laparoscopic sentinel node navigation surgery for early gastric cancer: a prospective multicenter trial.

Prospective multicenter trials have shown the feasibility of sentinel node (SN) navigation surgery using a dual tracer of dye and radioisotope for early gastric cancer. However, comparable trials using the indocyanine green (ICG) and the infrared ray laparoscopic system (IRLS) have not been reported. On the basis of our cohort studies, we assumed that the ICG imaging with the IRLS is as effective as the dual tracer in detecting SNs. Therefore, we conducted a prospective multicenter trial to assess the effectiveness and generalizability of the infrared ICG technique in patients with early gastric cancer. Patients with previously untreated cT1 gastric adenocarcinomas less than 4cm in gross diameter were eligible for inclusion in this study. SN mapping was performed by using ICG combined with IRLS technique. Following biopsy of the identified SNs, D2 or modified D2 laparoscopic gastrectomy was performed according to the current Japanese Gastric Cancer Association guidelines. Among the 47 patients who gave written informed consent, 44 were eligible from the surgical findings, for whom SN biopsy was performed. The detection rate of the lymphatic basin by the ICG with IRLS was 100% (44/44). The accuracy was also 100% (7/7) for detecting metastatic lymph node, which was verified on the permanent pathologic examination. Following the median follow-up of 114months (range, 60 to 120months), no recurrence (0/40) was observed. Although the number of patients was unequally distributed among the hospitals participating in the trial, the detection rates of SNs in low-volume hospitals were comparable to those in high-volume hospitals. Consequently, there was no learning curve in this trial. The infrared ICG imaging accurately detected the lymphatic basin and SNs with occult metastasis in SN-navigated gastrectomy for gastric cancer. This method was feasible even for low-volume surgeons and hospitals.

Laparoscopic sentinel node navigation surgery for early gastric cancer

AbstractThe sentinel node (SN) concept has revolutionized how the surgical staging of both melanoma and breast cancer are approached. Applying this concept can yield benefits for the patient by avoiding various complications relating to unnecessary prophylactic regional lymph node dissection in cases with negative SN for cancer metastasis. Clinical application of SN mapping for early gastric cancer had been controversial for years. However, single institutional results of laparoscopic SN mapping for early gastric cancer are considered acceptable in terms of detection rate and accuracy in determining lymph node status. For early stage gastric cancer such as cT1N0M0 – in which a better prognosis was generally achieved through conventional surgical approaches – an individualized, minimally invasive surgery that might retain the patient's quality of life should be established as the next surgical challenge. Although there are many issues still to resolve, laparoscopic minimized gastrectomy with SN navigation surgery or combined endoscopic mucosal resection and endoscopic submucosal dissection has the potential to achieve this goal.

Which Biopsy Method Is More Suitable Between a Basin Dissection and Pick-Up Biopsy for Sentinel Nodes in Laparoscopic Sentinel-Node Navigation Surgery (LSNNS) for Gastric Cancer?

Sentinel-node navigation surgery (SNNS) for breast cancer and melanoma has been accepted as a reasonable oncologic surgery worldwide. On the other hand, in gastric cancers that do metastasize well to the lymph node, the use of SNNS has been approached with care and performed in only limited cases. Some obstacles still have to be overcome, such as the shortcomings of SN tracers and the technical limitations of laparoscopic SN detection. The aims of this study were to determine whether laparoscopic SNNS is possible, and which biopsy method is more suitable for SN tracers, in gastric cancer, preoperatively diagnosed as < or =T2 and with < or =4-cm-sized lesions. Between January 2005 and October 2006, 92 consecutive patients that underwent LSNNS, using a combined indocyanine green and (99m)Tc-labeled tin colloid technique, were prospectively studied. SNs were laparoscopically removed by using two biopsy methods: a basin dissection and pick-up method, with the results of these two SN biopsy methods then compared with the final diagnosis obtained from a permanent section. With the pick-up method, SNs were identified in 23 of 42 patients (54.8%); however, with basin dissection, the detection rate was 96% (48 of 50 patients). The average number of SNs detected by the two methods were 2.1 (range, 0-4) and 3.5 (range, 1-7), respectively. The sensitivities of the two methods were 66% (4/6) and 85.7% (12/14), with specificities of 100% (17/17) and 100% (34/34), respectively. In gastric cancer, it was possible to perform LSNNS. At this moment, we believe the laparoscopic basin dissection technique with a dual-tracer injection, followed by SN detection on the back table, will be a reasonable procedure for gastric cancer, owing to the shortcomings related to the dye and radioisotope, the so-called "stained lymphatic duct only" and "shine-through phenomenon."