The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study.

BACKGROUND: Levodopa-carbidopa intestinal gel (LCIG) treatment, a unique drug delivery system for patients with advanced Parkinson's disease (PD), is covered by health insurance in Japan since September 2016. Various LCIG procedure/device-associated adverse events (AEs) have been reported; however, reports on their treatment have been limited. This is the first multicenter study to clarify the frequency and timing of device-related AEs. METHODS: Between September 2016 and December 2018, 104 patients introduced to the LCIG treatment for advanced PD in 11 hospitals were included. The patients' characteristics, AEs incidence, AEs time, and tube exchange time were investigated. RESULTS: The median follow-up period was 21.5 months. Minor AE cases were 29.4%, whereas major AE cases were 43.1%. Majority of major AEs (n = 55, 94.8%) were managed with endoscopic treatment, such as tube exchange. Few severe AEs required surgical treatment (n =3, 5.2%). The mean (range) exposure to percutaneous endoscopic gastrojejunostomy (PEG-J) was 14.7 (0-33) months. One year after the LCIG treatment introduction, 55 patients (54.0%) retained the original PEG-J tube. The mean PEG-J tube exchange time was 10.8 ± 7.0 months in all patients, 11.6 ± 4.7 and 10.5 ± 7.7 months in patients with scheduled exchange and who underwent exchange due to AEs, respectively. CONCLUSIONS: Some device-related AEs occurred during the LCIG treatment; however, only few were serious, most of which could be treated with simple procedures or tube replacement with endoscopy. Therefore, the LCIG treatment is feasible and safe and is a unique treatment option for PD, requiring endoscopists' understanding and cooperation.

Changes in Immunological Status in Patients With Metastatic Colorectal Cancer Treated With First-line Chemoimmunotherapy.

BACKGROUND/AIM: Chemoimmunotherapy is a promising treatment for various malignant diseases. In this study, we examined whether first-line chemoimmunotherapy using adoptive immune-cell therapy was effective for metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: The therapeutic efficacy and safety of the standard first-line chemoimmunotherapy with adoptive αß T cell therapy and bevacizumab were assessed using thirty-two patients with mCRC in our hospital. Immunological status after this chemoimmunotherapy was also evaluated. RESULTS: The response and disease control rates were 68.8% and 87.5%, respectively. Further, median progression-free and overall survival were 14.2 and 35.3 months. Immunotherapy-associated toxicity was minimal. Significant decrease in the change of monocyte number (p=0.006) and increase in the change of rate of lymphocyte-to-monocyte ratio (p=0.039) were seen in the complete response group. CONCLUSION: First-line chemoimmunotherapy with adoptive αß T cell therapy may be useful for mCRC.

Multicenter Evaluation of Clinical Efficacy and Safety of Per-oral Endoscopic Myotomy in Children.

OBJECTIVES: Per-oral endoscopic myotomy (POEM) is a recommended treatment modality for achalasia, but there is little published data for its use in children. The objective of the present study was to evaluate whether POEM is clinically effective and safe for children. METHODS: International multicenter retrospective study conducted in 14 tertiary centers that included consecutive children who underwent POEM between January 2012 and August 2018. Outcomes, such as clinical response were assessed whenever available. Adverse events and factors associated with clinical failure were also investigated. RESULTS: A total of 117 patients (mean ±â€ŠSD age: 14.2 ±â€Š3.7 years) underwent POEM for achalasia (type I, n = 36; type II n=66; type III, n=8). Among these, 30 (26%) were pretreated (botulinum injection and/or pneumatic dilatation). Mean ±â€ŠSD baseline Eckardt score was 7.5 ±â€Š2.0. Clinical success was achieved in 90.6% of cases (95%CI [83.8%;95.2%]) in the intention-to-treat analysis. The mean ±â€ŠSD Eckardt score post-POEM was 0.9 ±â€Š1.2 (P < 0.001). The mean duration of follow-up time 545 days (range: 100-1612). A total of 7 adverse events occurred (4 mucosotomies, 2 subcutaneous emphysema, 1 esopleural fistula). Gastroesophageal reflux symptoms were seen in 17 patients (15%); missing data for 10 patients (9%). There was a trend towards more frequent clinical failure in achalasia associated with genetic disorders (40% vs 8%, P = 0.069). CONCLUSIONS: POEM in pediatric patients appears to be effective and safe, although there was a trend towards more frequent clinical failure achalasia associated with genetic disorders. Further studies are needed to assess the long-term outcomes, especially the consequences of GERD.

Patient with mediastinitis caused by delayed mucosal damage after peroral endoscopic myotomy.

Peroral endoscopic myotomy (POEM) is a groundbreaking procedure for treating esophageal achalasia, and many reports from various facilities have described its safety and efficacy. However, there have been few reports on adverse events. Here, we report a case of a patient with mediastinitis caused by delayed mucosal damage after POEM. This case was the most severe among all POEM cases at our hospital. A 58-year-old man had experienced dysphagia and chest tightness since he was around 50 years old. At a previous hospital, he had been diagnosed with nonerosive reflux disease and had undergone fundoplication. As his symptoms did not improve, he was referred to our department. POEM was able to be finished but a stable visual field could not be maintained throughout procedure because of strong esophageal contractions. From findings of endoscopy and esophagography after POEM, the patient was diagnosed mediastinitis caused by delayed esophageal perforation. In this case, conservative treatment (fasting, antibiotic therapy, and enteral feeding) was successful. However, the option to administer surgical treatment, such as drainage, must not be overlooked.

New endoscopic finding of esophageal achalasia with ST Hood short type: Corona appearance.

BACKGROUND AND STUDY AIMS: Detecting esophageal achalasia remains a challenge. We describe the diagnostic utility of corona appearance, a novel endoscopic finding specific to esophageal achalasia. PATIENTS AND METHODS: Corona appearance and seven conventional endoscopic findings were compared for sensitivity and consistency (κ-value) among 53 untreated esophageal achalasia patients who underwent endoscopy at our hospital. The following criteria had to be met during lower esophageal sphincter examination using the attached ST Hood short-type for positive corona appearance: A) congestion inside the hood, B) ischemic change around the hood, and C) palisade vessels outside the hood. RESULTS: Corona appearance had the highest sensitivity (91%; κ-value, 0.71). Other findings in descending order of sensitivity included 1) functional stenosis of the esophagogastric junction (EGJ; 86%; κ-value, 0.58), 2) mucosal thickening and whitish change (71%; κ-value, 0.27), 3) abnormal contraction of the esophageal body (59%; κ-value, 0.32), 4) dilation of the esophageal lumen (58%; κ-value, 0.53), 5) liquid remnant (57%; κ-value, 0.51), 6) Wrapping around EGJ (49%; κ-value, 0.14), and 7) food remnant (30%; κ-value, 0.88). Even in 22 patients with poor (grade 1) intraluminal expansion, corona appearance had highest sensitivity (88%) compared to other endoscopic findings (κ-value, 0.63). CONCLUSIONS: Among endoscopic findings using a ST Hood short-type to diagnose esophageal achalasia, corona appearance had the highest sensitivity and its consistency (κ-value) among endoscopists was substantial compared to other endoscopic findings. Similar results were obtained for esophageal achalasia cases with poor expansion. Endoscopic diagnosis of esophageal achalasia with hood attached is useful.

Bladder pressure monitoring and CO2 gas-related adverse events during per-oral endoscopic myotomy.

Per-oral endoscopic myotomy (POEM) is a minimally invasive treatment for esophageal achalasia. However, POEM has the potential risk of inducing carbon dioxide (CO2) gas-related adverse events, such as pneumoperitoneum, pneumomediastinum, and pneumothorax. The aim of this study was to evaluate the usability of bladder pressure monitoring as an index of CO2 gas-related pneumoperitoneum. The monitoring of bladder pressure and lung compliance and the incidence of iatrogenic pneumoperitoneum were retrospectively studied in 20 patients who underwent POEM between June 2013 and March 2015. The bladder pressure was measured using a Foley catheter. Abdominal distention was found in nine patients. The bladder pressure was significantly higher in the nine patients with the distention findings compared with patients without distention [7 (6-9) mmHg vs. 1 (0-2) mmHg; P < 0.05]; however, the decrease in dynamic lung compliance was not significantly different compared with patients without distention [- 7 (- 9.3 to - 5.1) vs. - 5 (- 10.2 to - 1.3) ml/cmH2O; P = 0.62]. Based on postoperative changes on CT scans; the following were the observations: pneumomediastinum (55%), minor pneumothorax (5%), pleural effusion (45%), atelectasis (15%), pneumoperitoneum (85%), and subcutaneous emphysema (15%). No significant clinical status was found among the patients postoperatively. Bladder pressure monitoring might be useful for detecting pneumoperitoneum during POEM.

Contaminated drainage fluid and pancreatic fistula after pancreatoduodenectomy: A retrospective study.

BACKGROUND: Appropriate bacterial infection control in the perioperative period of a pancreaticoduodenectomy (PD) is important to prevent and manage serious complications including postoperative pancreatic fistula (POPF). In the present study, the clinical impact of bacterial contamination of intra-abdominal discharge on the rate of POPF after PD was analysed retrospectively. MATERIALS AND METHODS: The data for 82 consecutive patients who had undergone PD at our hospital between January 2009 and July 2014 were retrospectively analysed to review patient characteristics and perioperative and postoperative parameters. We compared the clinicopathologic features between patients with bacterial contamination of drainage fluid and those without bacterial contamination of drainage fluid. We also examined the relationship between POPF and bacterial contamination of drainage fluid, according to the bacterial strain involved. RESULTS: The incidence of Grade B/C POPF was significantly higher in the bacterial contamination positive group than in the bacterial contamination negative group (44.0% vs. 0.0%; p < 0.001). Soft gland texture and bacterial contamination of intra-abdominal discharge were found to be risk factors for POPF (odds ratio: 9.00, 95% confidence interval: 1.17-409.46 and odds ratio: 43.94, 95% confidence interval: 5.72-1992.04, respectively). The incidence of Grade B/C POPF was significantly higher in patients harbouring Pseudomonas aeruginosa than in patients harbouring bacteria other than Pseudomonas aeruginosa (p = 0.005). CONCLUSION: Bacterial contamination of intra-abdominal discharge is a risk factor for the development of pancreatic fistulae. Cases involving contamination with Pseudomonas aeruginosa warrant extreme caution.

Geriatric Nutritional Risk Index as a prognostic factor in patients with esophageal squamous cell carcinoma -retrospective cohort study.

PURPOSE: The Geriatric Nutritional Risk Index (GNRI) is a new index recently introduced to predict the risk of nutrition-related complications and mortality. Our aim is to examine the association between the GNRI and long-term prognosis in patients with esophageal squamous cell carcinoma (ESCC) who underwent esophagectomy. METHODS: The present study enrolled consecutive 216 patients with ESCC who underwent esophagectomy. The GNRI at admission to the hospital was calculated as follows: (1.489 × albumin, g/l) + (41.7 × present/ideal body weight). The characteristics and long-term prognosis were compared between four groups: the severe risk (GNRI: <82), moderate risk (GNRI: 82 to <92), low risk (GNRI: 92 to <98) and no risk (GNRI: >98) groups. The 5-year overall survival and independent prognostic factors were investigated, respectively. RESULTS: A decreased GNRI significantly correlated with unfavorable overall survival (p < 0.001). In all patients, a multivariate analysis demonstrated that the severe and moderate risk groups (GNRI: <92) (hazard ratio 0.50; p = 0.002), T factor (≥T2) (hazard ratio 0.52; p = 0.026), and N positive factor (hazard ratio 0.47; p = 0.004) were independent prognostic factors. In the subgroup analysis, which excluded patients with preoperative chemoradiotherapy, the severe and moderate risk groups (GNRI: <92) (hazard ratio 0.48; p = 0.0057), and T factor (≥T2) (hazard ratio; p = 0.021) were independent prognostic factors. CONCLUSIONS: GNRI is considered to be a useful prognostic factor in patients with ESCC undergoing esophagectomy.

Triclosan sutures for surgical site infection in colorectal cancer.

BACKGROUND: Among all procedures, surgical site infections (SSIs) in colorectal surgery continue to have the highest rate, accounting for 5%-45%. To prevent the bacterial colonization of suture material, which disables local mechanisms of wound decontamination, triclosan-coated sutures were developed. We assessed the effectiveness of triclosan-coated sutures used for skin closure on the rate of SSIs in colorectal cancer surgery. METHODS: Until August 2012, we used conventional methods for skin closure in colorectal cancer surgery at the Department of Gastroenterological Surgery, Fukuoka University Faculty of Medicine. Therefore, for the control group, we retrospectively collected surveillance data over a 1.5-y period. From September 2012, we began using triclosan-coated polydioxanone antimicrobial sutures (PDS plus) for skin and fascia closure. Hence, we collected data for the study group from September 2012 to October 2013. Differences in baseline characteristics and selection bias were adjusted using the propensity score-matching method. RESULTS: A total of 399 patients who underwent colorectal surgery were included in this study. There were 214 patients in the control group and 185 patients in the study group. Baseline patient characteristics were similar between the propensity score-matched groups. The incidence of SSIs was less in the study group. Multivariate logistic regression analysis showed that the site of the procedure, laparoscopic surgery, and using triclosan-coated sutures remained the independent predictors of SSIs. CONCLUSIONS: The use of triclosan-coated sutures was advantageous for decreasing the risk of SSIs after colorectal surgery.

Efficacy and safety of endoscopic submucosal dissection under general anesthesia.

AIM: To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD) under general anesthesia. METHODS: From January 2011 to July 2014, 206 consecutive patients had undergone ESD under general anesthesia for neoplasms of the stomach, esophagus, and colorectum were enrolled in this retrospective study. The efficacy and safety of ESD under general anesthesia were assessed. RESULTS: The en bloc resection rate of esophageal, gastric, and colorectal lesions was 100.0%, 98.3%, and 96.1%, respectively. The complication rate of perforation and bleeding were 0.0% and 0.0% in esophageal ESD, 1.7% and 1.7% in gastric ESD, and 3.9% and 2.0% in colorectal ESD, respectively. No cases of aspiration pneumonia were observed. All complications were managed by conservative treatment, with no surgical intervention required. CONCLUSION: With the cooperation of an anesthesiologist, ESD under general anesthesia appears to be a useful method, decreasing the risk of complications.

Long-term outcome of peroral endoscopic myotomy for achalasia treatment in a 9-year-old female patient.

Achalasia is a primary motility disorder with incomplete lower esophageal sphincter relaxation; it has an annual incidence of 0.11 cases per 100 000 children. Peroral endoscopic myotomy (POEM) is a new endoscopic treatment method for achalasia. Reports about POEM in pediatric patients are rare. We herein report the case of a 9-year-old female patient with achalasia who underwent POEM. The patient underwent endoscopic balloon dilatation because medication was not effective at a previous hospital; however, endoscopic balloon dilatation was not effective either. She then underwent successful POEM upon admission at our hospital. The patient was symptom-free at 2 years postoperatively with no signs of esophagitis in the absence of proton-pump inhibitor therapy.

Gastric metastasis from salivary duct carcinoma mimicking primary gastric cancer.

INTRODUCTION: We present a very rare case of gastric metastasis mimicking primary gastric cancer in a patient who had undergone surgery for salivary duct carcinoma. PRESENTATION OF CASE: A 67-year-old man had been diagnosed as having right parotid cancer and had undergone a right parotidectomy and lymph node dissection. The histological diagnosis was salivary duct carcinoma. One year after the surgery, a positron emission tomography-computed tomography scan using fluorodeoxyglucose (FDG) revealed an abnormal uptake of FDG in the left cervical, mediastinal, paraaortic, and cardiac lymph nodes; stomach; and pancreas. On gastroduodenoscopy, there was a huge, easily bleeding ulcer mimicking primary gastric cancer at the upper body of the stomach. Biopsy revealed poorly differentiated adenocarcinoma. Therefore, we were unable to differentiate between the primary gastric cancer and the metastatic tumor using gastroduodenoscopy and biopsy. Because of the uncontrollable bleeding from the gastric cancer, we performed an emergency palliative total gastrectomy. On histological examination, the gastric lesion was found to be metastatic carcinoma originating from the salivary duct carcinoma. DISCUSSION: In the presented case, we could not diagnose the gastric metastasis originating from the salivary duct carcinoma even by endoscopic biopsy. This is because the histological appearance of salivary duct carcinoma is similar to that of high-grade adenocarcinoma, thus, resembling primary gastric cancer. CONCLUSION: When we perform endoscopic examination of patients with malignant neoplasias, a possibility of metastatic gastric cancer should be taken into consideration.

Peroral endoscopic myotomy for esophageal achalasia: outcomes of the first over 100 patients with short-term follow-up.

BACKGROUND: POEM is a recently developed achalasia treatment method, which combines the efficacy of surgical myotomy with the benefits of endoscopic procedures. Very few studies have focussed on the efficacy and usefulness of POEM in over 100 cases. METHODS: The first 100 adult patients treated according to standard POEM technique in a single center and followed up for 3 months were identified and included in this study (men 42; women 58; mean age 48.2 ± 18.8; range 9-91 years) The pre- and postoperative assessments included Eckardt scores, manometry, endoscopy, and monitoring pH. RESULTS: Mean operative time was 150.8 ± 49.3 min (75-370 min). Adverse events over Grade IIIb by the Clavien-Dindo classification were not encountered. The mean preoperative and postoperative lower esophageal sphincter pressures were 43.6 ± 26.2 and 20.9 ± 12.7 mmHg, respectively, indicating a statistically significant decrease after POEM (P < 0.05). The mean preoperative and postoperative integrated relaxation pressure values were 33.5 ± 15.2 and 15.3 ± 6.5 mmHg (P < 0.05). Furthermore, the Eckardt score significantly decreased from 5.9 ± 2.5 preoperatively to 0.8 ± 0.9 postoperatively (P < 0.05). Clinical success was documented in 99 % of the patients. Short-term outcomes after POEM were extremely good and independent of the age, type of achalasia, and previous treatment method. The percent of monitoring time with a pH < 4 was 25.6 % (22/86) in patients not on proton-pump inhibitors. Nine patients were diagnosed with symptomatic gastroesophageal reflux disease (GERD); patients with reflux esophagitis and symptomatic GERD improved with PPI treatment. CONCLUSIONS: Our results confirm the efficacy of POEM in a large patient series and support POEM as one of the first-line achalasia therapies in the near future.

Histological findings of divided muscle after peroral endoscopic myotomy.

Peroral endoscopic myotomy (POEM) is a revolutionary therapy for achalasia and related disorders. POEM utilizes almost the same myotomy procedure as the Heller myotomy; thus, it would be expected to have the same or greater duration of therapeutic effect. However, to date, there have been no reports to prove the basis for this procedure in achalasia. In this case, we were able to histologically show the divided muscle after POEM since the patient had an esophagectomy for esophageal cancer. Histology showed that the muscle tissue divided by the POEM procedure was completely replaced by fibrosis. These findings may indirectly show the permanence of the POEM procedure.

A prospective analysis of GERD after POEM on anterior myotomy.

BACKGROUND: Peroral endoscopic myotomy (POEM) is an emerging, minimally invasive procedure capable of overcoming limitations of achalasia treatments, but gastroesophageal reflux disease (GERD) after POEM is of concern and its risk factors have not been evaluated. This prospective study examined GERD and the association of POEM with reflux esophagitis. METHODS: Achalasia patients were recruited from a single center. The pre- and postoperative assessments included Eckardt scores, manometry, endoscopy, and pH monitoring. RESULTS: Between September 2011 and November 2014, 105 patients underwent POEM; 70 patients were followed up 3 months after POEM. Postoperatively, significant reductions were observed in lower esophageal sphincter (LES) pressure [from 40.0 ± 22.8 to 20.7 ± 14.0 mmHg (P < 0.05)], LES residual pressure [from 22.1 ± 13.3 to 11.4 ± 6.6 mmHg (P < 0.05)], and Eckardt scores [from 5.7 ± 2.5 to 0.7 ± 0.8 (P < 0.05)]. Symptomatic GERD and moderate reflux esophagitis developed in 5 and 11 patients (grade B, n = 8; grade C, n = 3), respectively, and were well controlled with proton pump inhibitors. Univariate logistic regression analysis revealed integrated relaxation pressure was a predictor of ≥grade B reflux esophagitis. No POEM factors were found to be associated with reflux esophagitis. CONCLUSION: POEM is effective and safe in treating achalasia, with no occurrence of clinically significant refractory GERD. Myotomy during POEM, especially of the gastric side, was not associated with ≥grade B (requiring medical intervention) reflux esophagitis. Extended gastric myotomy (2-3 cm) during POEM is recommended to improve outcomes.

The Results of a Propensity Score Matching Analysis of the Efficacy of Abdominal Fascia and Skin Closure Using PDS® Plus Antibacterial (Polydioxanone) Sutures on the Incidence of Superficial Incisional Surgical Site Infections after Gastroenterologic Surgery.

BACKGROUND: Surgical site infections (SSIs) lead to prolonged hospitalization and increased cost of hospital stay after surgery. Therefore, the prevention of SSIs is one of the most critical tasks facing surgeons and nursing staff. In the present study, the efficacy of using triclosan-coated polidioxanone sutures (PDS® Plus Antibacterial Suture, (Ethicon Inc., Somerville, NJ) for abdominal closure was analyzed retrospectively using a propensity score matching analysis. PATIENTS AND METHODS: Of 1,768 patients who underwent gastroenterologic surgery at Fukuoka University Hospital between January 2009 and September 2013, 812 underwent abdominal closure using PDS Plus. These patients were compared retrospectively regarding the incidence of SSIs using a propensity score matching method with 956 patients treated in the previous period without abdominal closure using PDS Plus sutures. The propensity score was calculated from the age, gender, body mass index, smoking status, diabetes mellitus, use of steroid medication, malignant or benign disease, organ location, emergency or planned surgery, wound classification, the American Society of Anesthesiologists score, open or laparoscopic surgery, the length of the operation, and blood loss. RESULTS: Nine hundred sixty-six patients (483 matched sets) were enrolled by the propensity score matching method. No parameter used for the propensity score was different between the PDS Plus and control groups. Closure using PDS Plus could reduce the incidence of SSIs compared with that in the control group (p = 0.022). Of the parameters used for the propensity score, malignant disease (p = 0.0002), open surgery (p = 0.0020), a prolonged operation (p < 0.0001), high blood loss (p < 0.0001), the need for a transfusion (p = 0.019), and gastrointestinal tract surgery (p = 0.0059) were significant risk factors for the development of SSIs in the univariable analysis. In a multivariable regression model, open surgery (p < 0.0001), prolonged operation (p < 0.0001), gastrointestinal tract surgery (p = 0.001), and abdominal closure without PDS Plus (p < 0.0001) were the independent risk factors for the development of an SSI. The development of an SSI prolonged the hospital stay (p < 0.0001) and the use of antibiotic medication (p < 0.0001); abdominal closure using PDS Plus affected the antibiotic medication period (p = 0.013) but not the hospital stay (p = 0.40). CONCLUSION: Although abdominal fascia and skin closure using PDS Plus was compared with variable abdominal closure, the present findings suggest that abdominal fascia and skin closure using PDS Plus sutures could help prevent the development of SSIs after gastroenterologic surgery, as determined by a propensity score matching analysis.

Impact of perioperative probiotic treatment for surgical site infections in patients with colorectal cancer.

The aim of the present study was to estimate the effect of the perioperative administration of probiotics in patients undergoing colorectal cancer (CRC) surgery. The study focused on a total of 156 consecutive surgeries carried out from among all the elective CRC surgeries performed between April 2009 and March 2013. The patients involved in surgeries undertaken between April 2009 and October 2011 were placed in the non-probiotic group (group A, 81 patients) and those involved in surgeries between November 2011 and March 2013 were placed in the probiotic group (group B, 75 patients). Postoperative infectious complications were recorded, and the immune responses and fecal microbiota were determined. A breakdown of infectious complications showed that 21 (13.5%) patients experienced superficial incisional surgical site infections (SSIs), of which 16 patients were from group A (19.8%), and five patients from group B (6.7%) (P=0.016). The ImmuKnow® adenosine triphosphate values peaked on the first postoperative day (POD) in both groups. In group A, the ImmuKnow value of the first POD was increased significantly compared with the preoperative value (P=0.022). In group B, the value of the first POD did not increase compared with the preoperative value (P=0.28). In conclusion, probiotic treatment can reduce superficial incisional SSIs in patients undergoing CRC surgery. Perioperative probiotic treatment can enhance immune responses and improve the intestinal microbial environment.