Endoscopic submucosal dissection for tumors involving the ileocecal valve with extension into the terminal ileum: a multicenter study from the Hiroshima GI Endoscopy Research Group.

BACKGROUND: The efficacy and safety of endoscopic submucosal dissection (ESD) for tumors extending into the terminal ileum remain obscure. We aimed to evaluate the outcomes of ESD for tumors involving the ileocecal valve (ICV) with extension into the terminal ileum. METHODS: Sixty-eight patients (40 men; mean age, 67 years) with 68 tumors involving the ICV that were resected by ESD between December 2013 and December 2018 were included and classified into Group A (21 tumors with extension into the terminal ileum) and Group B (47 tumors without extension). ESD outcomes were compared between groups. RESULTS: The clinical features of the patients and tumors were not significantly different between the groups. There were no significant differences in en bloc resection rate (95% and 94%, respectively; p = 0.79), R0 resection rate (90% and 89%, respectively; p = 0.89), procedure time (95 ± 54 min and 94 ± 69 min, respectively; p = 0.64), postoperative bleeding rate (5% and 3%, respectively; p = 0.79), intraoperative perforation rate (0% and 4%, respectively; p = 0.34), delayed perforation rate (0% and 0%, respectively), or postoperative symptomatic stenosis rate (0% and 0%, respectively) between Groups A and B. No specific factors related to the outcomes of ESD were found by subgroup analysis according to the dominance and degree of circumference of the ICV. Local recurrence was observed in 1 patient in Group A who was retreated using ESD. CONCLUSIONS: ESD for tumors involving the ICV with extension into the terminal ileum is safe and effective.

Efficacy and safety comparison of scissor-type knives with needle-type knives for colorectal endoscopic submucosal dissection: a post-hoc propensity score-matched analysis (with videos).

BACKGROUND AND AIMS: Many knives have been developed to improve the efficacy and safety of endoscopic submucosal dissection (ESD). We aimed to evaluate the efficacy and safety of scissor-type knives for colorectal ESD compared with needle-type knives. METHODS: We performed a post-hoc propensity score-matched analysis in an 11-facility study between August 2013 and December 2018. A total of 2330 patients (2498 lesions) who underwent colorectal ESD were divided into needle-type (1923 patients, 2067 lesions) and scissor-type (407 patients, 431 lesions) knife groups. Short-term outcomes were compared between the 2 groups. RESULTS: Two-to-one propensity score-matched analysis identified 814 (709 patients) and 407 (386 patients) lesions in the needle- and scissor-type knife groups, respectively. The median resection speed was significantly faster in the needle-type group (18.3 mm2/min) than in the scissor-type group (13.2 mm2/min, P < .0001), whereas en-bloc and histologic complete resection rates were not significantly different between the needle- and scissor-type groups (96.8% [788/814] vs 98.3% [400/407], P = .1888 and 95.1% [774/814] vs 95.6% [389/407], P = .7763, respectively). The rate of lesions resected using a single knife was significantly higher in the scissor-type group (98.5% [401/407]) than in the needle-type group (43.9% [357/814], P < .0001). Rates of intraoperative perforation and delayed bleeding were significantly lower in the scissor-type group than in the needle-type group (.7% [3/407] vs 2.5% [20/814], P = .0431 for each). CONCLUSIONS: Scissor-type knives are safer for colorectal ESD. However, they are associated with slower resection speeds compared with needle-type knives. (Clinical trial registration number: UMIN000016197.).

Factors for conversion risk of colorectal endoscopic submucosal dissection: a multicenter study.

BACKGROUND: Endoscopic submucosal dissection (ESD) has become a widely accepted treatment method for colorectal tumors; however, there are some persistent problems. This multi-center study aimed to characterize the risk factors for incomplete resection and perforation in standardized colorectal ESD procedures. METHODS: This study included 2423 consecutive patients who underwent ESD for 2592 colorectal tumors between August 2013 and December 2018 at 11 institutions (1 academic hospital and 10 affiliated hospitals) from the Hiroshima GI Endoscopy Research Group. We evaluated the risk factors for interruption, piecemeal resection, and perforation of standardized colorectal ESD in relation to clinicopathologic and endoscopic characteristics. RESULTS: The incidences of interruption, piecemeal resection, and perforation were 0.7%, 2.9%, and 3.0%, respectively. Multivariate analysis identified the following risk factors for interruption: perforation during the procedure, deep submucosal invasion (> 1000 µm), poor scope operability, and severe submucosal fibrosis. The risk factors for piecemeal resection included poor scope operability, severe submucosal fibrosis, and procedure time (≥ 85 min). The risk factors for perforation during the procedure were severe submucosal fibrosis, poor scope operability, procedure time (≥ 85 min), and tumor size (≥ 40 mm). Independent risk factors for severe submucosal fibrosis included a history of biopsy and lesions located on the fold or flexure. CONCLUSIONS: Severe submucosal fibrosis and poor scope operability are the common risk factors for interruption, piecemeal resection, and perforation in standardized colorectal ESD.

Indications and outcomes of colorectal hybrid endoscopic submucosal dissection: a large multicenter 10-year study.

BACKGROUND AND AIMS: Hybrid endoscopic submucosal dissection (ESD) is a colorectal lesion resection procedure that includes both planned and salvage procedures. Previous colorectal hybrid ESD studies have involved single institutions or few operators over a short timeframe, and the size for indication has not been established. In this multicentre study, we investigated the clinical outcomes of hybrid ESD for colorectal tumors that met the 30 mm lesion size criterion. METHODS: From January 2008 to December 2018, colorectal hybrid ESD was performed for 172 lesions (diameter range, ≥ 20- < 30 mm) at Hiroshima GI Endoscopy Research Group. We compared clinicopathological characteristics and outcomes between 56 and 116 lesions in planned and salvage groups, respectively. We also compared data between 2008 and 2013 (the first period) and 2014 and 2018 (the second period) to assess operator experience. RESULTS: No significant difference was found in the complete en bloc resection rate between the planned and salvage groups (92.9% vs. 83.6%, respectively). Procedure time was shorter in the planned group (44.5 min) than in the salvage group (72.0 min, p < 0.01). The perforation rate was higher in the salvage group (21.6%) than in the planned group (0%, p < 0.01); however, the perforation rate during snaring in the salvage group was 1.8%. During the second period relative to the first period, we recorded a significantly higher complete en bloc resection rate (95.7% vs. 75.6%, respectively, p < 0.01) and experienced operator rate (75.5% vs. 53.9%, respectively, p < 0.01). Furthermore, no significant difference was found in the complete en bloc resection rate between the planned and salvage groups during the second period (100% vs. 94.4%, respectively). CONCLUSION: Colorectal hybrid ESD, especially salvage hybrid ESD performed by experienced operators, is adoptable and safe for lesions with diameters ranging from ≥ 20 to < 30 mm.

Salvage endoscopic submucosal dissection for local residual/recurrent colorectal tumor after endoscopic resection: Large multicenter 10-year study.

OBJECTIVES: For local residual/recurrent and endoscopic resection (ER) interrupted colorectal tumors, endoscopic retreatment is often difficult due to severe submucosal fibrosis. Endoscopic submucosal dissection (ESD) can achieve en bloc resection, even for tumors with severe submucosal fibrosis, although it is a risk factor for incomplete resection and perforation. We aimed to determine the safety and efficacy of colorectal ESD for local residual/recurrent tumors including ER interrupted tumors from a large multicenter study. METHODS: From January 2008 until December 2018, 3,937 colorectal tumors were resected by ESD at the Hiroshima GI Endoscopy Research Group. From this group, 81 local residual/recurrent tumors and 21 ER interrupted tumors were included. We analyzed ESD outcomes, particularly the difference between the early and late phases and re-recurrence after ESD for local residual/recurrent tumors. RESULTS: For local residual/recurrent tumors, en bloc and R0 resection rates were 95% (77/81) and 90% (73/81), respectively. The intraoperative perforation rate was 6% (5/81), and one patient required surgery. The delayed perforation rate was 2% (2/81), and one patient required surgery. For ER interrupted tumors, both the en bloc and R0 resection rates were 86% (18/21), with no major adverse events. For local residual/recurrent and ER interrupted tumors, the intraoperative perforation rate was significantly lower in the late phase compared with the early phase. Following curative resection for local residual/recurrent tumors, no local re-recurrences occurred. CONCLUSIONS: Colorectal ESD is an effective treatment for local residual/recurrent and ER interrupted tumors.

Real-world learning curve analysis of colorectal endoscopic submucosal dissection: a large multicenter study.

BACKGROUND: The current status of colorectal endoscopic submucosal dissection (ESD) performed by endoscopists without colorectal ESD experience is unknown. This study evaluated the quality of colorectal ESD performed by endoscopists without colorectal ESD experience. METHODS: We retrospectively examined the outcomes of 420 consecutive patients with 427 superficial colorectal tumors (male/female, 251/169; mean age, 69 years) who underwent ESD. The procedures were performed by 31 endoscopists without colorectal ESD experience using needle knife-type devices at 13 hospitals from October 2008 to June 2017. Cases were divided into the first and second phases according to the experience of the endoscopist: the first phase included the first 20 cases and the second phase included case 21 and beyond. We also identified factors associated with en bloc resection failure. RESULTS: Rates of colonic tumors, laterally spreading tumors of the non-granular type, poor scope operability, and severe submucosal fibrosis for the first phase were significantly lower than those for the second phase. The en bloc resection rates for the first and second phases were 93% and 96%, respectively. The factors associated with en bloc resection failure were poor scope operability (odds ratio [OR] 2.6; 95% confidence interval [CI] 1.0-6.5), severe submucosal fibrosis (OR 6.5; 95% CI 2.6-15.9), and the first 20 cases (OR 3.4; 95% CI 1.2-10.1). CONCLUSION: Inexperienced endoscopists should initially perform colorectal ESD for tumors without severe submucosal fibrosis under good scope operability for at least 20 cases.

Clinical outcomes of endoscopic submucosal dissection for colorectal tumors: a large multicenter retrospective study from the Hiroshima GI Endoscopy Research Group.

BACKGROUND AND AIMS: Although advanced high-volume centers have reported good outcomes of colorectal endoscopic submucosal dissection (ESD), a limited number of highly skilled experts in specialized institutions performed these procedures. We undertook a retrospective multicenter survey, which included nonspecialized hospitals, to investigate the clinical outcomes of colorectal ESD. METHODS: We recruited 1233 consecutive patients with 1259 colorectal tumors resected by ESD at 12 institutions. We evaluated the en bloc resection rate, histologic complete resection rate, curative (R0) resection rate, adverse events, and the long-term prognoses, including local recurrence, metachronous tumor development, and survival rate. RESULTS: The en bloc, histologic complete, and R0 resection rates were 92.6%, 87.4%, and 83.7%, respectively. The delayed bleeding, intraoperative perforation, and delayed perforation rates were 3.7%, 3.4%, and .4%, respectively. The long-term outcomes analysis included 1091 patients (88.4%). Local recurrences occurred in 1.7%, and metachronous tumors (>5 mm) developed in 11.0% of the patients. The 3- and 5-year overall survival rates were 95.1% and 92.3%, respectively. The number of colonic tumors, severe submucosal fibrosis, and en bloc resection rates were significantly higher in the high-volume centers (Group H) than those in the low-volume centers (Group L). The average tumor size in Group H was significantly larger than that in Group L. CONCLUSIONS: Colorectal ESDs are feasible, have acceptable adverse event risks, and favorable long-term prognoses. (Clinical trial registration number: UMIN000016197.).

Endoscopic submucosal dissection for anorectal tumor with hemorrhoids close to the dentate line: a multicenter study of Hiroshima GI Endoscopy Study Group.

BACKGROUND: The lower rectum close to the dentate line has distinct characteristics, making endoscopic submucosal dissection (ESD) of tumors challenging. We assessed clinical outcomes of ESD for such patients with hemorrhoids. METHODS: Sixty-four patients (mean age, 68 years) underwent ESD for anorectal tumors close to the dentate line. We divided patients into those with (Group A, 45 patients) and without hemorrhoids (Group B, 19 patients). We examined en bloc and histological en bloc resection rates, procedure time, complication rates, and postoperative prognosis after ESD. RESULTS: The mean tumor size was 43 mm. Histologic diagnoses were adenoma (42 %, 27/64), carcinoma in situ (44 %, 28/64), and T1 carcinoma (14 %, 9/64). There was no significant difference in en bloc resection (93 %, 42/45 vs. 95 %, 18/19) or postoperative bleeding rates (16 %, 7/45 vs. 11 %, 2/19) between Groups A and B, respectively. The mean procedural durations were 120 and 124 min, respectively, in Groups A and B. No perforations occurred. There was no significant difference in postoperative anal pain rate between Groups A (18 %, 8/45) and B (16 %, 3/19), and it resolved within a few days in all cases. There was one case of stricture in Group B. Two patients with T1 carcinoma underwent additional surgery, one underwent chemotherapy, and five had no additional treatment. No recurrence occurred during the follow-up period of 38 months. CONCLUSIONS: ESD is safe and effective for anorectal tumors close to the dentate line in patients with hemorrhoids.

Adherence and Effectiveness of MoviPrepⓇ in Bowel Preparation for Colonoscopy: A Multicenter Study from the Hiroshima GI Endoscopy Research Group.

Objectives: Bowel preparation is burdensome because of long cleansing times and large dose volumes of conventional polyethylene glycol (PEG) lavage solution NiflecⓇ (Nif). MoviPrep (Mov)Ⓡ is a hyperosmolar preparation of PEG, electrolytes, and ascorbic acid; despite the smaller dose volume of 2 L, it can be challenging for many patients. We examined a more effective and acceptable bowel preparation method without compromising cleanliness and effectiveness, combining low-residue diet and laxative (Modified Brown Method) in Mov administered 1 day pre-colonoscopy. Methods: This multicenter, randomized, open-label, parallel-group comparative study, conducted at Hiroshima University Hospital and 7 affiliated hospitals in May 2015-March 2016, evaluated adherence to and effectiveness of Mov in bowel preparation. Participants (n=380) were allocated to receive 1 of 3 pre-colonoscopy regimens: Nif+Modified Brown Method (Group A), Mov+Modified Brown Method (Group B), or Mov+Laxative (Group C). Results: Total intake volume showed no significant difference among the groups. Bowel preparation time was significantly shorter in Group B (112.4±44.8 min, n=118) than in Groups A (131.3±59 min, n=105) and C (122.6±48.1 min, n=115). Sleep disturbance (37%) was significantly higher in Group B than Group A; distension (11%) was significantly lower in Group C than in Groups A and B (p<0.05, respectively). No severe adverse events occurred in any group. Conclusions: Mov+Modified Brown method provided significantly shorter bowel preparation time, with no significant difference in total intake volume among the regimens. Mov+Laxative yielded significantly less distension than the other groups, with bowel preparation equivalent to that of the Nif+Modified Brown method.

Preceding endoscopic submucosal dissection for T1 colorectal carcinoma does not affect the prognosis of patients who underwent additional surgery: a large multicenter propensity score-matched analysis.

BACKGROUND: We analyzed the influence of preceding endoscopic submucosal dissection (ESD) on the prognosis of patients with T1 colorectal carcinoma (CRC) after additional surgery using propensity-score matching. METHODS: 1638 consecutive patients with T1 CRC were retrospectively identified between January 1998 and December 2016 at the Hiroshima GI Endoscopy Research Group. We assessed 602 patients with 602 T1 CRC who underwent additional surgery after ESD (n = 216) or surgery alone (n = 386). The enrolled patients were treated according to the Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016, and were defined as non-endoscopically curable (non-e-curable) when they did not satisfy its curative criteria. We analyzed the pathological characteristics and the prognosis of non-e-curable patients using propensity-score matching between the additional surgery after ESD and surgery alone groups. RESULTS: There were no cases of recurrence and lymph node metastasis among the e-curable patients. The rate of lymph node metastasis and recurrences in the non-e-curable patients were 10.8% and 2.6%, respectively. After propensity-score matching, there were no significant differences in the 5-year overall survival rates (96.9% vs. 92.0%), 5-year disease-free survival rates (96.7% vs. 96.7%) and 5-year disease-specific survival rates (100% vs. 98.6%) after treatment of T1 CRCs between the 2 groups in non-e-curable patients. CONCLUSIONS: Preceding ESD with histological en bloc resection for patients with T1 CRC did not affect their oncologic behavior adversely after additional surgery.

Long-term outcomes after treatment for T1 colorectal carcinoma: a multicenter retrospective cohort study of Hiroshima GI Endoscopy Research Group.

BACKGROUND: We aimed to clarify the long-term outcomes of patients with T1 colorectal carcinoma (CRC) after endoscopic resection (ER) and surgical resection. METHODS: We examined T1 CRC patients treated during 1992-2008 and who had ≥5 years of follow-up. Patients who did not meet the curative criteria after ER according to the Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines were defined as "non-endoscopically curable" and classified into three groups: ER alone (Group A: 121 patients), additional surgery after ER (Group B: 238 patients), and surgical resection alone (Group C: 342 patients). Long-term outcomes and predictors of recurrence were analyzed. RESULTS: Of the 882 patients with T1 CRC, 701 were non-endoscopically curable. Among these patients, recurrence and 5-year overall survival (OS) rates were 0.6 and 91.1%, respectively. In Groups A, B, and C, recurrence rates were 5.0, 5.5, and 3.8%, OS rates were 79.3, 92.4, and 91.5% (p < 0.01), and 5-year disease-free survival (DFS) rates were 98.1, 97.9, and 98.5%, respectively. Thirty-two patients experienced local recurrence or distant/lymph node metastasis (Group A: 6; Group B: 13; Group C: 13) and 14 patients died of primary CRC (Group A: 3; Group B: 7; Group C: 4). Age ≥65 years, protruded gross type, positive lymphatic invasion, and high budding grade were significant predictors of recurrence in non-endoscopically curable patients. CONCLUSIONS: Our findings supported the JSCCR criteria for endoscopically curable T1 CRC. ER for T1 CRC did not worsen the clinical outcomes of patients who required additional surgical resection.

Long-term outcomes after treatment for pedunculated-type T1 colorectal carcinoma: a multicenter retrospective cohort study.

BACKGROUND: The risk for lymph node metastasis and the prognostic significance of pedunculated-type T1 colorectal carcinomas (CRCs) require further study. We aimed to assess the validity of the 2014 Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines based on long-term outcomes of pedunculated-type T1 CRCs. METHODS: In this multicenter retrospective cohort study, we examined 176 patients who underwent resection endoscopically or surgically at 14 institutions between January 1990 and December 2010. Patients meeting the JSCCR curative criteria were defined as "endoscopically curable (e-curable)" and those who did not were "non-e-curable". We evaluated the prognosis of 116 patients (58 e-curable, 58 non-e-curable) who were observed for >5 years after treatment. RESULTS: Overall incidence of lymph node metastasis was 5 % (4/81; 95 % confidence interval 1.4-12 %: three cases of submucosal invasion depth ≥1000 µm [stalk invasion] and lymphatic invasion, one case of head invasion and budding grade 2/3). There was no local or metastatic recurrence in the e-curable patients, but six of them died of another cause (observation period, 80 months). There was no local recurrence in the non-e-curable patients; however, distant metastasis was observed in one patient. Death due to the primary disease was not observed in non-e-curable patients, but six of them died of another cause (observation period, 72 months). CONCLUSIONS: Our data support the validity of the JSCCR curative criteria for pedunculated-type T1 CRCs. Endoscopic resection cannot be considered curative for pedunculated-type T1 CRC with head invasion alone.