Background
Although laparoscopic total gastrectomy (LTG) is considered a technically demanding procedure with safety issues, it has been performed in several hospitals in Japan. Data from a ...nationwide web-based data entry system for surgical procedures (NCD) that started enrollment in 2011 are now available for analysis.
Methods
A retrospective cohort study was conducted using data from 32,144 patients who underwent total gastrectomy and were registered in the NCD database between January 2012 and December 2013. Mortality and morbidities were compared between patients who received LTG and those who underwent open total gastrectomy (OTG) in the propensity score-matched Stage I cohort and Stage II–IV cohort.
Results
There was no significant difference in mortality rate between LTG and OTG in both cohorts. Operating time was significantly longer in LTG while the blood loss was smaller. In the Stage I cohort, LTG, performed in 33.6% of the patients, was associated with significantly shorter hospital stay but significantly higher incidence of readmission, reoperation, and anastomotic leakage (5.4% vs. 3.6%,
p
< 0.01). In the Stage II–IV cohort, LTG was performed in only 8.8% of the patients and was associated with significantly higher incidence of leakage (5.7% vs. 3.6%,
p
< 0.02) although the hospital stay was shorter (15 days vs. 17 days,
p
< 0.001).
Conclusion
LTG was more discreetly introduced than distal gastrectomy, but remained a technically demanding procedure as of 2013. This procedure should be performed only among the well-trained and informed laparoscopic team.
Coronavirus-19 (COVID-19) caused by SARS-CoV-2 has become a global pandemic. Risk of transmission may occur during endoscopy and the goal is to prevent infection among healthcare professionals while ...providing essential services to patients. Asia was the first continent to have a COVID-19 outbreak, and this position statement of the Asian Pacific Society for Digestive Endoscopy shares our successful experience in maintaining safe and high-quality endoscopy practice at a time when resources are limited. Sixteen experts from key societies of digestive endoscopy in Asia were invited to develop position statements, including patient triage and risk assessment before endoscopy, resource prioritisation and allocation, regular monitoring of personal protective equipment, infection control measures, protective device training and implementation of a strategy for stepwise resumption of endoscopy services after control of the COVID-19 outbreak.
Background
Laparoscopic distal gastrectomy (LDG) is becoming the standard procedure for gastric cancer. However, supporting evidence thus far has been derived primarily from randomized control trials ...conducted by centers of excellence. In the present study we used the National Clinical Database (NCD) in Japan to prospectively accumulate data from diverse types of hospitals and examine whether LDG is a safe and valid standard procedure.
Methods
From the NCD, 169 institutions were selected to form a cohort that was considered to be representative of Japan. From August 2014 to July 2015, 5288 patients who underwent LDG were registered prospectively, and clinical data were acquired through the NCD. To compare surgical outcomes between open distal gastrectomy (ODG) and LDG, we adjusted for confounding factors using propensity score matching, ultimately retrieving data from 1067 patients in each group.
Results
There were no significant differences in the number of in-hospital deaths in the ODG and LDG groups (3/1067 vs. 6/1067;
P
= 0.51) or in the number of reoperations (20/1067 vs. 29/1067;
P
= 0.19). However, the length of hospital stay was significantly shorter in the LDG. Although wound infection and dehiscence were more common in the ODG group, LDG was more often associated with grade B or higher pancreatic fistulas.
Conclusion
The safety and minimal invasiveness of LDG were confirmed in the present Japanese nationwide survey. However, care must be taken to prevent the formation of pancreatic fistulas with LDG, and further improvements in surgical quality are warranted in this regard.
Clinical practice guidelines for peroral endoscopic myotomy Inoue, Haruhiro; Shiwaku, Hironari; Iwakiri, Katsuhiko ...
Digestive endoscopy,
September 2018, 2018-Sep, 2018-09-00, 20180901, Letnik:
30, Številka:
5
Journal Article, Conference Proceeding
Recenzirano
Peroral endoscopic myotomy (POEM) is a novel clinical technique developed in Japan used to treat esophageal achalasia and esophageal motility disorders. This technique has been rapidly accepted and ...widely disseminated throughout our clinical practice because of its low invasiveness, technical novelty, and high efficacy. Since the advent of POEM, there have been no clinical guidelines that clearly indicated its standard of care, and these guidelines have been anticipated both nationally and internationally by clinicians who engage in POEM practice. In 2017, to meet these needs, the Japan Gastroenterological Endoscopy Society (JGES) launched the guideline committee for POEM. Based on the guideline development process proposed by the Medical Information Network Distribution Service (MINDS), the guideline committee initially created research questions on POEM and conducted a systematic review and meta‐analysis on each topic. The clinical research extracted from databases for these clinical questions and the systematic review mainly comprised a few retrospective studies with a small number of participants and short trial periods; hence, the strength of the evidence and recommendations derived from these results was low. Throughout this process, the guideline committee met thrice: once on May 13, 2017, and again on September 17, 2017, to formulate the draft. A consensus meeting was then held on January 14, 2018, in Tokyo to establish the guideline statements and finalize the recommendations using the modified Delphi method. This manuscript presents clinical guidelines regarding current standards of practice and recommendations in terms of the nine chief topics in POEM.
Background
Controversy persists regarding the technical feasibility of laparoscopic total gastrectomy (LTG), and to our knowledge, no prospective study with a sample size sufficient to investigate ...its safety has been reported. We aimed to compare the postoperative morbidity and mortality rates in patients undergoing LTG and open total gastrectomy (OTG) for gastric cancer in prospectively enrolled cohort using nationwide web-based registry.
Methods
From August 2014 to July 2015, consecutive patients undergoing LTG or OTG (925 and 1569 patients, respectively) at the participating institutions were enrolled prospectively into the National Clinical Database registration system. We constructed propensity score (PS) models separately in four facility yearly case-volume groups, and evaluated the postoperative morbidity and mortality in PS-matched 1024 patients undergoing LTG or OTG.
Results
The incidence of overall morbidity were 84 (16.4%) in the OTG and 54 (10.3%) in the LTG groups (
p
= 0.01).The incidence of anastomotic leakage and pancreatic fistula grade B or above were not significantly different between the two groups (LTG 5.3% vs. OTG 6.1%,
p
= 0.59, LTG 2.7% vs. OTG 3.7%,
p
= 0.38, respectively). There were also no significant differences in the 30-day and in-hospital mortality rates between the two groups (LTG 0.2% vs. OTG 0.4%,
p
= 0.56; LTG 0.4% vs. OTG 0.4%,
p
= 1.00, respectively).
Conclusion
The results from our nationally representative data analysis showed that LTG could be a safe procedure to treat gastric cancer compared to OTG. The indication for LTG should be considered carefully in a clinical setting.
Laparoscopic surgery for gastric cancer is technically feasible, but it is not widely accepted because it has not been evaluated from the standpoint of oncologic outcome. We conducted a ...retrospective, multicenter study of a large series of patients in Japan to evaluate the short- and long-term outcomes of laparoscopic gastrectomy for early gastric cancer (EGC).
The study group comprised 1294 patients who underwent laparoscopic gastrectomy during the period April 1994 through December 2003 in 16 participating surgical units (Japanese Laparoscopic Surgery Study Group). The short- and long-term outcomes of these patients were examined.
Distal gastrectomy was performed in 1185 patients (91.5%), proximal gastrectomy in 54 (4.2%), and total gastrectomy in 55 (4.3%); all were performed laparoscopically. The morbidity and mortality rates associated with these operations were 14.8% and 0%, respectively. Histologically, 1212 patients (93.7%) had stage IA disease, 75 (5.8%) had stage IB disease, and 7 (0.5%) had stage II disease (the UICC staging). Cancer recurred in only 6 (0.6%) of 1294 patients treated curatively (median follow-up, 36 months; range, 13-113 months). The 5-year disease-free survival rate was 99.8% for stage IA disease, 98.7% for stage IB disease, and 85.7% for stage II disease.
Although our findings may be considered preliminary, our data indicate that laparoscopic surgery for EGC yields good short- and long-term oncologic outcomes.
Abstract
Background
Improvements in early detection and treatment have resulted in an increasing number of long-term survivors of colorectal cancer (CRC). For the survivors, second primary cancer and ...recurrence are important issues; however, evidence for an appropriate surveillance strategy remains limited.
This study aimed to investigate the frequency and timing of second primary cancer in patients after surgery for exploring an appropriate surveillance strategy by using an integrated analysis of three large-scale randomized controlled trials in Japan.
Methods
The eligibility criteria of three trials included histologically confirmed CRC and having received surgery. The timing, site and frequency of second primary cancers and recurrence were investigated. Risk factors associated with second primary cancers were also examined. The standardized incidence ratio (SIR) of second primary cancers compared with the national database of the Japan Cancer Registry was estimated.
Results
A total of 2824 patients were included in this study. The cumulative incidence of second primary cancer increased over time. The SIR of any second primary cancer was 1.07 (95% CI: 0.94–1.21). The SIR for second primary cancers of colon was 1.09 (95% CI: 0.79–1.47). The cumulative incidence of recurrence almost reached plateau at 3 years.
Conclusions
A common surveillance strategy for the general population can be applied even for curatively resected CRC patients, as the risk of second primary cancers was almost the same as that of the general population.
Our integrated analysis of three large-scale randomized controlled trials in Japan concluded that the Japanese and other countries’ guidelines recommending surveillance strategy for resected colorectal cancer patients might be appropriate.
Objectives
Sodium alginate (SA) solution has characteristic viscoelasticity. We aimed to determine efficacy and safety of 0.6% SA for submucosal injection during endoscopic submucosal dissection ...(ESD) in patients with localized neoplastic lesion in the esophageal and gastric mucosa.
Methods
We conducted a randomized controlled study at six major hospitals in Japan including 130 patients with endoscopically localized neoplastic lesion in the esophageal and gastric mucosa and eligible for ESD. Patients were randomly assigned to SA or 0.4% sodium hyaluronate (SH) group (control); ESD was performed using a submucosal injection of SA/SH. As a primary outcome measure, non‐inferiority of SA against SH was investigated using en bloc complete resection in ESD and formation and maintenance of mucosal elevation upon injection as an efficacy index. Adverse events during the study were evaluated as safety outcome measures. This study was registered with Pharmaceuticals and Medical Devices Agency (clinical trial no. 28‐277/2016‐18; clinical trial identification no. KP2013‐009_C001).
Results
Efficacy rate of submucosal injection during ESD was 91.7% (55/60) and 88.7% (55/62) in the SA and SH groups, respectively, demonstrating non‐inferiority of SA against SH. Adverse events for which a causal relationship with submucosal injection solution could not be eliminated were noted in 8.2% (5/61) and 4.7% (3/64) in the SA and SH groups, respectively, but symptoms disappeared without treatment/after drug administration in both groups.
Conclusions
In Japan, 0.4% SH is the only commercially approved formulation for submucosal injection during ESD. The study results may expand submucosal injection solution options in clinical practice.
Background
Laparoscopic gastrectomy has become a common surgical treatment for gastric cancer in eastern Asian countries. However, a large-scale prospective study to investigate the benefit of ...laparoscopy-assisted distal gastrectomy (LADG) regarding long-term outcomes has never been reported. We have already reported the short-term outcomes of this study. Here we report long-term outcomes as the secondary endpoints of this study after a 5-year follow-up period.
Methods
This study comprised patients with clinical stage I gastric cancer who were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic lymph node dissection was performed by credentialed gastric surgeons who had each conducted at least 30 LADG and 30 open gastrectomy procedures. The primary endpoint was the proportion of patients who developed either anastomotic leakage or pancreatic fistula. The secondary endpoints included overall survival and relapse-free survival.
Results
From November 2007 to September 2008, 176 eligible patients were enrolled, comprising 140 patients with pathological stage IA disease, 23 patients with pathological stage IB disease, 9 patients with pathological stage II disease, and 4 patients with pathological stage IIIA disease. No patients had recurrent disease, and three of the patients died within the follow-up period. The 5-year overall survival was 98.2% (95% confidence interval 94.4–99.4%) and the 5-year relapse-free survival was 98.2% (95% confidence interval 94.4–99.4%).
Conclusions
The long-term outcomes of stage I gastric cancer patients undergoing LADG seem comparable to those of patients undergoing an open procedure, although this result should be confirmed by a randomized control trial. We have already completed accrual of 921 patients for a multicenter randomized phase III trial (JCOG0912) to confirm the noninferiority of LADG compared with open gastrectomy in terms of relapse-free survival.
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