Multicenter randomized control study of the efficacy of SO clip in colorectal endoscopic submucosal dissection (ESD). (SO clip study in colorectal ESD): Randomized controlled trial.

INTRODUCTION: Endoscopic submucosal dissection (ESD) allows the en bloc resection of colorectal epithelial tumors regardless of size. Although ESD is minimally invasive and yields favorable outcomes, it is technically difficult and requires a long procedure time. In addition, colorectal ESD is associated with a particularly high risk of complications, due to the thin bowel wall, bowel flexion, and peristalsis.Direct visualization of the submucosal layer by traction of the lesion after mucosal dissection would make ESD performance easier. S-O clips traction lesions toward the lumen, facilitating direct visualization of the submucosal layer, resulting in efficient dissection due to the traction effect and adequate dissection depth. Use of this traction device can contribute to shortening the procedure time and reducing the risk of complications. This multicenter randomized controlled trial will evaluate the usefulness of the S-O clip in colorectal ESD and assess the procedure time and frequency of complications associated with the procedure. METHODS/DESIGN: This multicenter, randomized control trial will enroll 200 patients at 4 hospitals in Japan undergoing ESD for colorectal epithelial tumors. Patients who meet the inclusion and exclusion criteria will be randomized to undergo ESD using S-O clips or conventional ESD. Patients will be randomized by a computer-generated random sequence with stratification by operator experience (trainee or expert), tumor location (colon/rectum), and institution. The primary endpoint will be ESD procedure time, defined as the time from the start of the local injection into the submucosal layer to the end of dissection. Other outcomes will include the rates of procedural complications, en bloc resection and cure. DISCUSSION: ESD using the S-O clip is expected to shorten procedure time, reduce the incidence of adverse events, and standardize the procedure. This study may resolve clinical questions about whether ESD using the S-O clip traction device is more effective and safer than conventional ESD.

Histology of metastatic colorectal cancer in a lymph node.

BACKGROUND: A primary colorectal cancer (CRC) tumor can contain heterogeneous cancer cells. As clones of cells with different properties metastasize to lymph nodes (LNs), they could show different morphologies. Cancer histologies in LNs of CRC remains to be described. METHODS: Our study enrolled 318 consecutive patients with CRC who underwent primary tumor resection with lymph node dissection between January 2011 and June 2016. 119 (37.4%) patients who had metastatic LNs (mLNs) were finally included in this study. Cancer histologies in LNs were classified and compared with pathologically diagnosed differentiation in the primary lesion. The association between histologies in lymph node metastasis (LNM) and prognosis in patients with CRC was investigated. RESULTS: The histologies of the cancer cells in the mLNs were classified into four types: tubular, cribriform, poorly differentiated, and mucinous. Same degree of pathologically diagnosed differentiation in the primary tumor produced various histological types in LNM. In Kaplan-Meier analysis, prognosis was worse in CRC patients with moderately differentiated adenocarcinoma who had at least some mLN also showing cribriform carcinoma than for those whose mLNs all showed tubular carcinoma. CONCLUSIONS: Histology in LNM from CRC might indicate the heterogeneity and malignant phenotype of the disease.

Efficacy of EUS-guided celiac plexus neurolysis in combination with EUS-guided celiac ganglia neurolysis for pancreatic cancer-associated pain: a multicenter prospective trial.

OBJECTIVES: This study evaluated the efficacy of endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in combination with EUS-guided celiac ganglia neurolysis (EUS-CGN) for pancreatic cancer-associated pain. METHODS: This multicenter prospective trial was registered in the University Hospital Medical Information Network (UMIN000031228). Fifty-one consecutive patients with pancreatic cancer-associated pain who presented at one of five Japanese referral centers between February 2018 and March 2021 were enrolled. EUS-CGN was added in cases of visible celiac ganglia. The primary endpoint was effectiveness, defined as a decrease in the numerical rating scale (NRS) by ≥ 3 points. NRS data were prospectively acquired at 1 week after the procedure to evaluate its effectiveness and the extent of pain relief. RESULTS: The technical success rates of EUS-CPN and EUS-CGN were 100% and 80.4%, respectively. The overall efficacy rate was 82.4% [90% confidence interval (CI) 71.2-90.5, P < 0.0001]. The complete pain relief rate was 27.4%. The adverse events rate was 15.7%. The average pain relief period was 72 days. The efficacy rate was higher in the EUS-CPN plus EUS-CGN group than in the EUS-CPN alone group. EUS-CPN plus EUS-CGN was superior to EUS-CPN alone for achieving complete pain relief (P = 0.045). EUS-CGN did not improve the average length of the pain relief period. CONCLUSIONS: EUS-CPN combined with EUS-CGN is safe, feasible, and effective for pain relief in patients with pancreatic cancer. The patients who received additional EUS-CGN had a better short-term response. CLINICAL TRIAL NUMBER: UMIN000031228.

[A case of non-alcoholic fatty liver disease (NAFLD) aggravated after treatment with raloxifene].

A 70-year-old woman presented with abnormal liver function test 3 months after the introduction of daily intake of raloxifene, a selective estrogen receptor modulator, for osteoporosis. She had a history of NAFLD, diabetes mellitus and depression. The ratio of the computed-tomographic value of the liver against that of the spleen decreased remarkably. Pathological examination of the liver biopsy revealed severe steatosis. We thought her NAFLD was aggravated by raloxifene and discontinued the drug. The liver function test results improved and the computed tomographic liver-spleen ratio rose. This is the second case report of NAFLD becoming aggravated after treatment with raloxifene. It still remains unclear how raloxifene affects liver. Monitoring liver function is recommended when treating with raloxifene.