1.Feasibility and safety of transesophageal endoscopic resection for benign mediastinal tumors
Jia YU ; Liyun MA ; Wei SU ; Shengli LIN ; Quanlin LI ; Pinghong ZHOU ; Pingting GAO
Chinese Journal of Clinical Medicine 2025;32(3):362-368
Objective To explore the feasibility, safety, and efficacy of transesophageal endoscopic surgery for mediastinal tumors. Methods A retrospective analysis was conducted on the clinical data of 17 patients who underwent transesophageal endoscopic resection for benign mediastinal tumors at the Endoscopy Center of Zhongshan Hospital, Fudan University, between January 1, 2016 and December 31, 2024. Epidemiological characteristics, surgical parameters, adverse events, and follow-up outcomes were analyzed. Results Among the 17 patients, there were 9 males and 8 females, with an average age of (42.4±14.5) years and an average tumor size of (2.6±1.6) cm. Pathological types included esophageal duplication cysts (6 cases, 35.3%), bronchogenic cysts (5 cases, 29.4%), gastroenteric cysts (3 cases, 17.6%), schwannomas (2 cases, 11.8%), and lymphangioma (1 case, 5.9%). Fourteen patients (82.4%) underwent submucosal tunneling endoscopic resection (STER), 3 patients (17.6%) underwent natural orifice transluminal endoscopic mediastinal surgery. All surgeries were successfully completed without conversion to open surgery. En bloc resection was achieved in 11 patients (64.7%), with an average operative time of (60.9±32.6) min. No intraoperative bleeding or mucosal injury occurred, and 4 patients (23.5%) experienced minor complications (pneumothorax, fever, recurrent laryngeal nerve injury), all of which resolved with conservative treatment. The average postoperative hospital stay was (3.2±1.5) days, and no recurrence was observed during the follow-up period. Conclusions Transesophageal endoscopic resection of benign mediastinal tumors is a safe, effective, and minimally invasive treatment method. Further validation of its efficacy and safety through large-scale prospective studies is warranted.
2.Short-term efficacy of endoscopic submucosal dissection for early carcinoma in the remnant stomach
Ying ZHOU ; Qi JIANG ; Baisheng CHEN ; Xia WU ; Qiuli JIANG ; Nashan LI ; Xingyu WU ; Pinghong ZHOU ; Weifeng CHEN ; Jianwei HU
Chinese Journal of Clinical Medicine 2025;32(4):620-626
Objective To explore the short-term efficacy of endoscopic submucosal dissection (ESD) in the treatment of early carcinoma in the remnant stomach. Methods A retrospective study was conducted on 45 patients with early residual gastric cancer underwent ESD at the Endoscopy Center of Zhongshan Hospital, Fudan University from December 2014 to April 2024, with a total of 45 lesions. The patients were divided into an anastomotic group (n=15) and a non-anastomotic group (n=30) based on the location of tumor occurrence, and their clinical data, endoscopic diagnosis and treatment, and histopathological conditions were compared between the two groups. Results All 45 patients had lesions with redness and erosion. There were 9 cases of poor lifting of submucosal injection in the anastomotic group and 2 cases in the non-anastomotic group, respectively, and the difference was statistically significant (P<0.05). ESD surgery was performed on 13 lesions in the anastomotic group and 28 lesions in the non-anastomotic group, with surgery times of 80.00 (50.00, 100.00) min and 55.00 (43.75, 80.00) min, respectively. The difference in surgery time between the two groups was statistically significant (P=0.03). Among the 45 patients, ESD surgery achieved curative resection in 35 cases, including 11 cases in the anastomotic group and 24 cases in the non-anastomotic group, with no statistically significant difference. Conclusions Careful preoperative evaluation of early carcinoma in the remnant stomach is essential to prevent oversight. Lesions at anastomotic sites and suture lines present higher technical challenges for complete resection. ESD is safe and effective, with auxiliary traction technique available when necessary.
4.Prediction model for difficulty of peroral endoscopic myotomy: an independent cohort validation
Yimeng REN ; Xinyang LIU ; Quanlin LI ; Pinghong ZHOU
Chinese Journal of Clinical Medicine 2025;32(2):283-287
Objective To validate the efficacy of the prediction model for difficulty of peroral endoscopic myotomy (POEM) through an independent cohort. Methods A total of 617 patients with achalasia who underwent POEM at the Endoscopy Center of Zhongshan Hospital, Fudan University from January 2021 to December 2023 were included. The general data of patients were collected, and the predictive value of the prediction model for POEM difficulty in the validation cohort was estimated. The stratified analysis was undergone according to the difficulty risk scores. Results In 617 consecutive patients, technical difficulty was observed in 90 cases (14.6%). The predictive model demonstrated moderate discriminatory capacity with an area under the receiver operating characteristic curve (AUC) of 0.711 (95%CI 0.643-0.780). Patients were stratified into three risk categories according to the difficulty risk scores: low-risk (<0.1), medium-risk (0.1-0.25), and high-risk (≥0.25). The corresponding technical difficulty rates were 7.3%, 16.9%, and 51.6%, respectively. Conclusion The prediction model for POEM difficulty built by our center shows good stability and discrimination, and has good clinical application value.
5.Analysis of clinicopathological and endoscopic features and endoscopic efficacy of early gastroesophageal junction cancer
Ying ZHOU ; Qi JIANG ; Baisheng CHEN ; Xia WU ; Qiuli JIANG ; Pinghong ZHOU ; Weifeng CHEN
Chinese Journal of Digestive Endoscopy 2025;42(6):487-490
To explore the clinicopathological characteristics, endoscopic manifestations, and efficacy of endoscopic procedure for early gastroesophageal junction cancer, a retrospective analysis was conducted on the patients who underwent endoscopic submucosal dissection (ESD) and pathologically confirmed early cancer of the gastroesophageal junction at Zhongshan Hospital, Fudan University and Xiamen Branch from November 2014 to October 2021. The pathological and gastroscopic features, as well as short-term efficacy of ESD were analyzed. Among the 401 patients, there were 332 males with the age of 66.02±7.93 years, and 69 females with the age of 66.26±9.31 years. The male-to-female ratio was 4.8∶1. Siewert type Ⅱ accounted for 70.82% (284/401). Lesions involving the lesser curvature accounted for 57.10% (229/401). Endoscopic manifestation of mucosal erythema accounted for 96.26% (386/401). Lesion morphology of 0-Ⅱc type accounted for 38.15% (153/401) and tubular adenocarcinoma accounted for 86.53% (347/401). The en bloc resection rate of ESD was 99.75% (400/401), with a curative resection rate of 72.82% (292/401). It is indicates that early gastroesophageal junction cancer predominantly occurs in middle-aged and elderly males. It is mostly Siewert type Ⅱ, and involves the lesser curvature, and primarily presents as type 0-Ⅱc morphology. The lesions are most commonly manifested as mucosal redness and are predominantly moderately to well-differentiated adenocarcinomas. ESD demonstrates a safe and effective therapeutic approach for early gastroesophageal junction cancer.
6.A clinical research of endoscopic submucosal dissection for ileocecal valve lipoma
Shaobin LUO ; Li WANG ; Keyang FAN ; Zuqiang LIU ; Hao HU ; Wenzheng QIN ; Zhen ZHANG ; Mingyan CAI ; Jianwei HU ; Lili MA ; Yiqun ZHANG ; Yunshi ZHONG ; Quanlin LI ; Pinghong ZHOU
Chinese Journal of Digestive Endoscopy 2025;42(6):469-473
Objective:To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD) for the treatment of ileocecal valve lipoma.Methods:A retrospective cohort study was performed on data of ileocecal lipoma patients who underwent ESD at the Endoscopy Center of Zhongshan Hospital, Fudan University from December 2013 to June 2023. According to the lesion location, the patients were divided into ileocecal valve group and cecum group. The operation time, operation speed, en bloc resection rate, complications, and follow-up outcomes between the two groups were compared.Results:A total of 59 patients with ileocecal lipoma were enrolled, including 31 patients in the ileocecal valve group and 28 patients in the cecum group.There were no significant differences in gender, age, specimen size, or lesion size between the two groups ( P>0.05). Lipomas in both the ileocecal valve group and the cecum group were successfully resected by ESD. The en bloc resection rates were 100.0% (31/31) and 92.9% (26/28) respectively, and the difference was not statistically significant ( χ2=0.033, P=0.133). Median operative duration significantly differed between the two groups ( ileocecal valve group 26 min VS cecum group 20 min, Z=-0.136, P=0.027), as did resection speed (ileocecal valve group 0.14 cm2/min VS cecum group 0.24 cm2/min, Z=-0.223, P=0.022). Adverse events included one postoperative fever in the ileocecal valve group and one delayed bleeding in the cecum group. During the median follow-up of 38 months (7-106 months), there was no case of residual tumor or recurrence. Conclusion:Despite technical challenges in ESD of ileocecal valve lipoma, it is still a safe, feasible and effective treatment method.
7.Evaluation of efficacy and tolerability of TCIC-001 for bowel preparation prior to colonoscopy: an exploratory randomized controlled clinical trial
Baohui SONG ; Xiaolong ZHUANG ; BAHETINUER JIASHAER ; Xiaoyue XU ; Jiaxin XU ; Danfeng ZHANG ; Yunshi ZHONG ; Pinghong ZHOU ; Mingyan CAI
Chinese Journal of Clinical Medicine 2025;32(5):743-747
Objective To compare the efficacy and tolerability of the novel bowel-cleansing agent TCIC-001 and the traditional polyethylene glycol (PEG) regimen for bowel preparation prior to colonoscopy. Methods Prospective inclusion of 62 patients who were scheduled to undergo colonoscopy at Zhongshan Hospital, Fudan University from July 2021 to July 2022. They were randomly divided into TCIC-001 group (n=31) and PEG group (n=31) using a random number table method. The TCIC-001 group took TCIC-001 orally, drinking water in stages, with a total liquid intake of 1 500 mL; the PEG group took PEG orally, taking it in 4 doses, with a total liquid intake of 3 000 mL. The primary endpoint indicator is the quality of intestinal hygiene evaluated by the Boston Bowel Preparation Scale (BBPS), the secondary endpoint indicators were medication adherence, medication duration, frequency of bowel movements, duration of bowel movements, and incidence of adverse events between two groups. Results No significant differences were observed in sex, age, or defecation frequency between the two groups. For efficacy, both groups achieved equivalent bowel cleanliness, with a “good preparation” rate of 93.55% and comparable BBPS score of each intestinal segment and total scores. For tolerability, the TCIC-001 group had a shorter medication duration compared to the PEG group ([48.8±25.9] min vs [82.8±28.4] min, P<0.001), a longer defecation duration ([288.6±74.0] min vs [236.5±74.3] min, P<0.001), and a lower incidence of first defecation before medication completion (9.68% vs 41.94%, P=0.004). Regarding safety, no significant differences were observed between the TCIC-001 group and the PEG group in incidences of chloride disturbances (0% vs 9.68%) and calcium disturbances (3.23% vs 6.45%), and no other adverse events. Conclusions TCIC-001 demonstrated comparable bowel-cleansing efficacy to PEG while significantly improving tolerability (reduced medication time and lower risk of premature defecation) and maintaining favorable safety.
8.Preclinical efficacy and safety evaluation of a novel gastrointestinal mucosal elevation gel in vivo porcine model
Yicheng TIAN ; BAHETINUER JIASHAER ; Yan ZHU ; Wei XIA ; Pinghong ZHOU ; Mingyan CAI
Chinese Journal of Clinical Medicine 2025;32(5):768-775
Objective To evaluate the efficacy and safety of a novel gastrointestinal mucosal elevation gel in vivo porcine model. Methods Eight healthy white pigs were selected, which were uesd to bump height evaluation (n=2) and safety evaluation (n=6). The sample (alimentary canal mucosa bump gel sample) and the control sample (disposable endoscopic submucosal filler of alimentary canal) were respectively injected into the submucosa of pig gastric antrum and gastric body. In the evaluation of elevation height, the morphology, persistence, and clinical safety of mucosal elevation were observed and recorded immediately and 30 minutes after injection. In safety evaluation, endoscopic mucosal resection was performed after injection, and the mucosal protrusion shape, product efficacy, and clinical safety were observed and recorded at immediate and 7-day time points. After observation, all animals were euthanized and tissue samples were collected and excised for histopathological evaluation. Results In elevation height evaluation, sample group showed a steep elevation immediately after surgery, exhibiting a more pronounced elevation morphology compared to control group (P=0.019). Only two (25%) sites of the elevation showed slight collapse in 30 minutes after surgery, and the durability notably increased compared to control group (8 all collapsed, P<0.001). In safety evaluation, the average trauma area of sample group was 1.77 mm2, which was significantly lower than control group (2.65 mm2, P<0.001). There was no statistical difference among average injection dose per unit area, surgical time per unit area, and en bloc resection rate. Sample group showed mild ulcers and only 1 (12.5%) site of mild bleeding at immediate time point after surgery. No bleeding, perforation, ulcer or edema was observed in sample group 7 days after surgery, and no statistical difference was identified compared to control group. Histopathological evaluation found that the gastric antrum and body tissues exhibited moderate injury and mild edema at immediate time point, accompanied by mild inflammatory cellular infiltration. At 7-day time point, gastric antrum tissues demonstrated moderate injury, mild edema and mild inflammatory cellular infiltration, with 1 (12.5%) site of tissues infected, while in gastric body tissues, no bleeding was observed, whereas moderate injury and mild edema were evident, accompanied by mild inflammatory cellular infiltration and 3 (37.5%) sites of tissues infected, all of which were not statistically different from control group. Conclusion The novel gastrointestinal mucosal elevation gel exhibited steep elevation morphology, long-lasting elevation height, and favorable efficacy and safety in preclinical animal trials, showing enormous clinical application potential.
9.Endoscopic submucosal dissection of gastrointestinal polyps with a novel plasma radio frequency generator and a disposable mucosal incision knife: A prospective, multicenter, non-inferiority, randomized, controlled clinical trial
Baohui SONG ; Guijun SHI ; Xiaoyue XU ; Jiaxin XU ; Li FENG ; Jianguang XU ; Pinghong ZHOU ; Mingyan CAI
Chinese Journal of Gastrointestinal Surgery 2025;28(4):384-391
Objective:To evaluate the efficacy and safety of a new plasma radiofrequency generator and a disposable mucosal incision knife for endoscopic submucosal dissection (ESD) of gastrointestinal lesions.Methods:This study is a prospective, randomized, non-inferiority multicenter study (Chinese Clinical Trial Registry No.: ChiCTR2000041394). The inclusion criteria for cases are as follows: (1) being able to understand and voluntarily participate in this clinical trial, and voluntarily signing the informed consent form; (2) being 18-70 years old, regardless of gender; (3) having a gastrointestinal lesion and meeting the endoscopic treatment conditions for the indications of endoscopic submucosal dissection (ESD). The exclusion criteria are: (1) meeting the contraindications for ESD; (2) having a surgical contraindication due to coagulation dysfunction or still taking anticoagulants 1 week before surgery; (3) having coagulation dysfunction, that is, the prothrombin time is prolonged by more than 3 seconds (more than 5 seconds in patients with liver disease), or the activated partial thromboplastin time is prolonged by more than 10 seconds, and the platelet count is < 70×10?/L; (4) having severe cardiopulmonary insufficiency and being unable to tolerate the surgery; (5) being a reproductive-aged woman with a positive blood or urine pregnancy test or a lactating woman; (6) the investigator deems that there are other factors that are not suitable for inclusion or affect the subject's participation. Patients who underwent ESD treatment for gastrointestinal lesions from March 2019 to April 2023 at the Endoscopy Center of Zhongshan Hospital Affiliated to Fudan University, the Department of Gastroenterology of Minhang District Central Hospital in Shanghai, and the Department of Gastroenterology of Quzhou People's Hospital were prospectively included. The experimental group used a new plasma radiofrequency therapy instrument and a disposable mucosal incision knife, while the control group used a high-frequency electrosurgical system and a disposable mucosal incision knife. The primary efficacy indicator was the en bloc resection success rate, the secondary efficacy indicators included the coagulation success rate, and the operation stability of the plasma radiofrequency therapy instrument and the disposable mucosal incision knife; the safety indicators included the incidence of intraoperative bleeding, intraoperative perforation, and postoperative complications. Results:The study cohort comprised 194 patients, 95 in the experimental group and 99 in the control group. Analysis of the full set showed rates of en bloc resection of 97.89% (93/95) and 96.97% (96/99) in the experimental and control groups, respectively; the difference being 0.53% (-5.58%, 6.64%). Analysis of the compliance set showed rates of en bloc resection of 97.83% (90/92) and 96.88% (93/96) in the experimental and control groups, respectively; the difference being 0.58% (-5.79%, 6.94%). These data indicate that the rate of en bloc resection in the experimental group using plasma radiofrequency therapy and disposable mucosal incision was not inferior to that of the control group. The rates of achieving intraoperative coagulation in the experimental and control groups were 7.14% (5/70) and 5.97% (4/67), respectively; this difference is not statistically significant ( P=1.000). The control group had a significantly better rate of using the same instruments throughout the procedure than did the experimental group ( P<0.001). In the safety analysis set, the incidences of intraoperative and postoperative adverse events did not differ significantly between the two groups (both P>0.05). Conclusion:Plasma radiofrequency therapy equipment and a disposable mucosal incision knife are safe and effective instruments for performing ESD of gastrointestinal lesions.
10.Clinical study on endoscopic resection of giant submucosal tumors in the esophagus or gastric cardia
Zhongqi LI ; Yun WANG ; Shengli LIN ; Pinghong ZHOU ; Pingting GAO
Chinese Journal of Gastrointestinal Surgery 2025;28(5):544-550
Objective:Endoscopic resection of giant submucosal tumors (SMTs) in the esophagus and gastric cardia is challenging. The aim of this study was to investigate the safety and efficacy of various endoscopic procedures for resection of esophageal or gastric cardia SMTs with longitudinal diameter ≥7 cm and/or transverse diameter ≥3.5 cm.Methods:In this retrospective cohort study, we analyzed data of 109 patients with giant esophageal/cardia SMTs originating in the muscularis propria who had undergone endoscopic resection in Zhongshan Hospital from July 2017 to February 2022. Inclusion criteria were as follows: (1) SMT diameter ≥7 cm longitudinally or ≥3.5 cm transversely; (2) presence of symptoms requiring intervention; and (3) tumor originating in the muscularis propria. Exclusion criteria included severe comorbidities, coagulation disorders, prior surgery, or tumor adjacent to vital organs precluding endoscopic treatment. The primary outcomes were en bloc and piecemeal resection rates, whereas secondary outcomes comprised adverse events and long-term survival.Results:Among the 109 patients who had successfully undergone endoscopic resection, the median tumor diameters were 7.5 (4.0-15.0) cm, and 4.5 (1.5-7.0) cm. Submucosal tunneling endoscopic resection, endoscopic full-thickness resection, and endoscopic submucosal excavation were performed on 77, 22, and 10 patients, respectively. The median duration of the procedures was 90 (30-300) minutes. The overall en bloc resection rate was 78.9% (86/109), and piecemeal resection rate 21.1% (23/109). Major adverse events occurred in 12.8% of patients (14/109), comprising pneumothorax or pleural effusion ( n=12), esophageal-pleural fistula ( n=3), severe delayed bleeding ( n=1), tunnel infection with abdominal abscess ( n=1), pulmonary abscess ( n=1), abdominal abscess ( n=1), and postoperative esophageal stricture ( n=1). During a median follow-up period of 33.6 (15.4-70.4) months, no tumor recurrences or metastases were detected. Multivariate analysis revealed that transverse diameter ≥4.5 cm was an independent risk factor for piecemeal resection (OR=6.016, 95%CI: 2.180-16.597, P<0.001); longitudinal diameter ≥9.0 cm (OR=2.728, 95%CI: 1.005-7.405, P=0.049) and transverse diameter ≥4.5 cm (OR=2.942, 95%CI: 1.099-7.874, P=0.032) were independent risk factors for prolonged operation time; and longitudinal diameter ≥9.0 cm (OR=5.040, 95%CI: 1.425-17.828, P=0.012) and piecemeal resection (OR=6.280, 95%CI: 1.741-22.656, P=0.005) were independent risk factors for major adverse events. Conclusion:Endoscopic resection is a safe and effective treatment modality for giant esophageal or gastric cardia SMTs of longitudinal diameter ≥9.0 cm and transverse diameter ≥4.5 cm.

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