Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.
Anastomotic Leak ; Asian Continental Ancestry Group ; Conversion to Open Surgery ; Gastrectomy* ; Humans ; Japan* ; Laparoscopy ; Medical Oncology* ; Non-Randomized Controlled Trials as Topic ; Prospective Studies ; Stomach Neoplasms*

Purpose: Despite annual endoscopy, patients with metachronous remnant gastric cancer (MRGC) following proximal gastrectomy (PG) are at times ineligible for endoscopic resection (ER). This study aimed to clarify the clinical risk factors for ER inapplicability. Materials and Methods: We reviewed the records of 203 patients who underwent PG for cT1 gastric cancer between 2006 and 2015. The remnant stomach was categorized as a pseudofornix, corpus, or antrum. Results: Thirty-two MRGCs were identified in the 29 patients. Twenty MRGCs were classified as ER (ER group, 62.5%), whereas 12 were not (non-ER group, 37.5%). MRGCs were located in the pseudo-fornix in 1, corpus in 5, and antrum in 14 in the ER group, and in the pseudofornix in 6, corpus in 4, and antrum in 2 in the non-ER group (P=0.019). Multivariate analysis revealed that the pseudo-fornix was an independent risk factor for non-ER (P=0.014). In the non-ER group, MRGCs at the pseudo-fornix (n=6) had more frequent undifferentiated-type histology (4/6 vs. 0/6), deeper (≥pT1b2; 6/6 vs. 2/6) and nodal metastasis (3/6 vs. 0/6) than non-pseudo-fornix lesions (n=6). We examined the visibility of the region developing MRGC on an annual follow-up endoscopy one year before MRGC detection. In seven lesions at the pseudofornix, visibility was only secured in two (28.6%) because of food residues. Of the 25 lesions in the non-pseudo-fornix, visibility was secured in 21 lesions (84%; P=0.010). Conclusions Endoscopic visibility increases the chances of ER applicability. Special preparation is required to ensure the complete clearance of food residues in the pseudo-fornix.

Purpose: Despite annual endoscopy, patients with metachronous remnant gastric cancer (MRGC) following proximal gastrectomy (PG) are at times ineligible for endoscopic resection (ER). This study aimed to clarify the clinical risk factors for ER inapplicability. Materials and Methods: We reviewed the records of 203 patients who underwent PG for cT1 gastric cancer between 2006 and 2015. The remnant stomach was categorized as a pseudofornix, corpus, or antrum. Results: Thirty-two MRGCs were identified in the 29 patients. Twenty MRGCs were classified as ER (ER group, 62.5%), whereas 12 were not (non-ER group, 37.5%). MRGCs were located in the pseudo-fornix in 1, corpus in 5, and antrum in 14 in the ER group, and in the pseudofornix in 6, corpus in 4, and antrum in 2 in the non-ER group (P=0.019). Multivariate analysis revealed that the pseudo-fornix was an independent risk factor for non-ER (P=0.014). In the non-ER group, MRGCs at the pseudo-fornix (n=6) had more frequent undifferentiated-type histology (4/6 vs. 0/6), deeper (≥pT1b2; 6/6 vs. 2/6) and nodal metastasis (3/6 vs. 0/6) than non-pseudo-fornix lesions (n=6). We examined the visibility of the region developing MRGC on an annual follow-up endoscopy one year before MRGC detection. In seven lesions at the pseudofornix, visibility was only secured in two (28.6%) because of food residues. Of the 25 lesions in the non-pseudo-fornix, visibility was secured in 21 lesions (84%; P=0.010). Conclusions Endoscopic visibility increases the chances of ER applicability. Special preparation is required to ensure the complete clearance of food residues in the pseudo-fornix.

Purpose: Despite annual endoscopy, patients with metachronous remnant gastric cancer (MRGC) following proximal gastrectomy (PG) are at times ineligible for endoscopic resection (ER). This study aimed to clarify the clinical risk factors for ER inapplicability. Materials and Methods: We reviewed the records of 203 patients who underwent PG for cT1 gastric cancer between 2006 and 2015. The remnant stomach was categorized as a pseudofornix, corpus, or antrum. Results: Thirty-two MRGCs were identified in the 29 patients. Twenty MRGCs were classified as ER (ER group, 62.5%), whereas 12 were not (non-ER group, 37.5%). MRGCs were located in the pseudo-fornix in 1, corpus in 5, and antrum in 14 in the ER group, and in the pseudofornix in 6, corpus in 4, and antrum in 2 in the non-ER group (P=0.019). Multivariate analysis revealed that the pseudo-fornix was an independent risk factor for non-ER (P=0.014). In the non-ER group, MRGCs at the pseudo-fornix (n=6) had more frequent undifferentiated-type histology (4/6 vs. 0/6), deeper (≥pT1b2; 6/6 vs. 2/6) and nodal metastasis (3/6 vs. 0/6) than non-pseudo-fornix lesions (n=6). We examined the visibility of the region developing MRGC on an annual follow-up endoscopy one year before MRGC detection. In seven lesions at the pseudofornix, visibility was only secured in two (28.6%) because of food residues. Of the 25 lesions in the non-pseudo-fornix, visibility was secured in 21 lesions (84%; P=0.010). Conclusions Endoscopic visibility increases the chances of ER applicability. Special preparation is required to ensure the complete clearance of food residues in the pseudo-fornix.

Purpose: Despite annual endoscopy, patients with metachronous remnant gastric cancer (MRGC) following proximal gastrectomy (PG) are at times ineligible for endoscopic resection (ER). This study aimed to clarify the clinical risk factors for ER inapplicability. Materials and Methods: We reviewed the records of 203 patients who underwent PG for cT1 gastric cancer between 2006 and 2015. The remnant stomach was categorized as a pseudofornix, corpus, or antrum. Results: Thirty-two MRGCs were identified in the 29 patients. Twenty MRGCs were classified as ER (ER group, 62.5%), whereas 12 were not (non-ER group, 37.5%). MRGCs were located in the pseudo-fornix in 1, corpus in 5, and antrum in 14 in the ER group, and in the pseudofornix in 6, corpus in 4, and antrum in 2 in the non-ER group (P=0.019). Multivariate analysis revealed that the pseudo-fornix was an independent risk factor for non-ER (P=0.014). In the non-ER group, MRGCs at the pseudo-fornix (n=6) had more frequent undifferentiated-type histology (4/6 vs. 0/6), deeper (≥pT1b2; 6/6 vs. 2/6) and nodal metastasis (3/6 vs. 0/6) than non-pseudo-fornix lesions (n=6). We examined the visibility of the region developing MRGC on an annual follow-up endoscopy one year before MRGC detection. In seven lesions at the pseudofornix, visibility was only secured in two (28.6%) because of food residues. Of the 25 lesions in the non-pseudo-fornix, visibility was secured in 21 lesions (84%; P=0.010). Conclusions Endoscopic visibility increases the chances of ER applicability. Special preparation is required to ensure the complete clearance of food residues in the pseudo-fornix.