Objective:To investigate the safety and efficacy of Fuzheng Kangfu (FK) formula combined with chemotherapy in the treatment of pancreatic cancer.Methods:A retrospective analysis was conducted on 95 pancreatic cancer patients who received conventional chemotherapy between June 2021 and June 2024. The patients were divided into the integrated traditional Chinese medicine treatment group (treatment group) and the chemotherapy-only group (control group) according to whether receiving FK formula during chemotherapy. Baseline characteristics, clinical indicators before and after treatment, incidence of adverse reactions, and overall survival were compared between the two groups.Results:After propensity score matching, 39 patients were included in each group. Compared with the control group, the treatment group presented significantly higher globulin levels [28.60 (24.70, 32.15) g/L vs 24.90 (22.40, 29.95) g/L], alongside lower levels of D-dimer [1 200 (720, 1 690) μg/L vs 2 230 (1 040, 3 330) μg/L], creatinine (64.29±15.97 μmol/L vs 77.71±12.26 μmol/L), urea nitrogen [3.43(2.58, 4.67) mmol/L vs 4.87 (3.80, 6.24) mmol/L], and fasting blood glucose [4.68(3.95, 5.73) mmol/L vs 6.91 (5.27, 7.70) mmol/L]. Furthermore, the treatment group exhibited significantly greater decreases in C-reactive protein (CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), indirect bilirubin, D-dimer, fibrinogen, and urea nitrogen levels compared to the control group. Conversely, the decreases of hemoglobin level and body mass index in the control group were more pronounced than that of the treatment group. The incidence of chemotherapy-related adverse reactions such as leukopenia (7.7% vs 33.3%), anemia (15.4% vs 35.9%), liver dysfunction (28.2% vs 53.8%), gastrointestinal reactions (5.1% vs 20.5%), and neurotoxicity (0.0% vs 15.4%) in the treatment group was notably lower than that in the control group. The treatment group showed prolonged median survival (14 month vs 9 month). The 1, 1.5 and 2-year survival rates of the treatment group were higher than the control group (56.76% vs 42.95%, 35.77% vs 32.72% and 23.85% vs 19.63%). All aforementioned differences were statistically significant (all P value <0.05). Conclusions:The integration of the FK formula with chemotherapy in the management of pancreatic cancer could effectively mitigate clinical manifestations, enhance quality of life, extend survival duration, and diminish chemotherapy-induced adverse effects.

Objective:To investigate the safety and efficacy of Fuzheng Kangfu (FK) formula combined with chemotherapy in the treatment of pancreatic cancer.Methods:A retrospective analysis was conducted on 95 pancreatic cancer patients who received conventional chemotherapy between June 2021 and June 2024. The patients were divided into the integrated traditional Chinese medicine treatment group (treatment group) and the chemotherapy-only group (control group) according to whether receiving FK formula during chemotherapy. Baseline characteristics, clinical indicators before and after treatment, incidence of adverse reactions, and overall survival were compared between the two groups.Results:After propensity score matching, 39 patients were included in each group. Compared with the control group, the treatment group presented significantly higher globulin levels [28.60 (24.70, 32.15) g/L vs 24.90 (22.40, 29.95) g/L], alongside lower levels of D-dimer [1 200 (720, 1 690) μg/L vs 2 230 (1 040, 3 330) μg/L], creatinine (64.29±15.97 μmol/L vs 77.71±12.26 μmol/L), urea nitrogen [3.43(2.58, 4.67) mmol/L vs 4.87 (3.80, 6.24) mmol/L], and fasting blood glucose [4.68(3.95, 5.73) mmol/L vs 6.91 (5.27, 7.70) mmol/L]. Furthermore, the treatment group exhibited significantly greater decreases in C-reactive protein (CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), indirect bilirubin, D-dimer, fibrinogen, and urea nitrogen levels compared to the control group. Conversely, the decreases of hemoglobin level and body mass index in the control group were more pronounced than that of the treatment group. The incidence of chemotherapy-related adverse reactions such as leukopenia (7.7% vs 33.3%), anemia (15.4% vs 35.9%), liver dysfunction (28.2% vs 53.8%), gastrointestinal reactions (5.1% vs 20.5%), and neurotoxicity (0.0% vs 15.4%) in the treatment group was notably lower than that in the control group. The treatment group showed prolonged median survival (14 month vs 9 month). The 1, 1.5 and 2-year survival rates of the treatment group were higher than the control group (56.76% vs 42.95%, 35.77% vs 32.72% and 23.85% vs 19.63%). All aforementioned differences were statistically significant (all P value <0.05). Conclusions:The integration of the FK formula with chemotherapy in the management of pancreatic cancer could effectively mitigate clinical manifestations, enhance quality of life, extend survival duration, and diminish chemotherapy-induced adverse effects.

Objective:To compare the safety and efficacy of two-person and three-person operation of endoscopic retrograde cholangiopancreatography (ERCP) after Roux-en-Y anastomosis.Methods:A total of 31 cases of bile duct stones where endoscopic access was successful and papilla was detected after Roux-en-Y anastomosis in Hangzhou First People's Hospital from January 2021 to September 2022 were recruited. Based on the retrospective study, 17 patients with the two-person operation (an operator and an assistant completed selective intubation) were included in group A from January to December 2021, and 14 patients with the three-person operation (an operator and two assistants completed the selective intubation) from January to September 2022 were included in group B. The success rate, the time of intubation, and complication incidence of the two groups were compared.Results:The intubation success rate of all enrolled patients was 90.32% (28/31). There was no significant difference in the intubation success rate between group A and group B [82.35% (14/17) VS 100.00% (14/14), P=0.232]. The intubation time in group B was significantly less than that of group A (42.89±6.57 min VS 61.02±9.23 min) with significant difference ( t=5.77, P<0.001). The incidence of postoperative complication of ERCP in all enrolled patients was 16.13% (5/31). There was no significant difference in the postoperative complication incidence between group A and group B [17.65% (3/17) VS 14.29% (2/14), P=1.000]. Conclusion:For patients undergoing ERCP after Roux-en-Y anastomosis, the two methods were not statistically different in terms of the intubation success rate and the incidence of procedure-related complications. But three-person operation shows clear advantage in terms of operation time.

Objective:To compare the efficacy and safety of endoscopic retrograde cholangiopancreatography (ERCP) assisted with colonoscope and enteroscope in patients with history of Roux-en-Y anastomosis.Methods:A retrospective study was performed on the data of 70 patients who underwent ERCP assisted with standard colonoscope or single balloon enteroscope after Roux-en-Y reconstruction in Hangzhou Hospital Affiliated to Nanjing Medical University from January 2017 to December 2020. Patients were divided into the standard colonoscopy group ( n=43) and the single balloon enteroscopy group ( n=27) according to endoscopy. The success rates of insertion, intubation and ERCP, and incidence of complications were compared. Results:A total of 81 ERCP procedures were performed in 70 patients. The insertion success rates of the standard colonoscopy group and the single balloon enteroscopy group were 91.8% (45/49) and 78.1% (25/32), respectively, showing no significant difference ( χ2=2.04, P=0.153). The success rates of primitive papilla intubation in the two groups were 74.1% (20/27) and 1/6, showing significant difference ( P=0.016). The ERCP success rates of the standard colonoscopy group and the single balloon enteroscopy group were 75.5% (37/49) and 59.4% (19/32), showing no significant difference ( χ2=2.36, P=0.124). The post operative complication incidences of the standard colonoscopy group and the single balloon enteroscopy group were 4.1% (2/49) and 9.4% (3/32), showing no significant difference ( χ2=0.25, P=0.620). Conclusion:ERCP assisted with standard colonoscope and single balloon enteroscope is safe and effective in patients after Roux-en-Y anastomosis. Standard colonoscopic ERCP can become an endoscopy solution for patients with biliary tract disease after Roux-en-Y reconstruction.

Objective:To explore the preventive effects of pancreatic duct stent combined with rectal administration of indomethacin suppository for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) after difficult bile duct intubation during endoscopic retrograde cholangiopancreatography (ERCP).Methods:From January 2019 to December 2021, patients with biliary and pancreatic diseases undergoing ERCP in Hangzhou Hospital Affiliated to Nanjing Medical University were given 100 mg indomethacin suppository to anal canal 30 minutes before the operation. And those with difficult bile duct intubation during the operation ( n=204) were included in this study. According to the random number table, they were divided into the combination group (implanted with pancreatic duct stent during the operation, n=104) and the indomethacin group (not implanted with stent, n=100). The incidences of hyperamylasemia and PEP were compared between the two groups. Results:The incidences of postoperative hyperamylasemia [21.2% (22/104) VS 34.0% (34/100), χ2=4.22, P=0.040] and PEP [14.4% (15/104) VS 32.0% (32/100), χ2=8.88, P=0.003] in the combination group were significantly lower than those in the indomethacin group. There was no significant difference in the incidence of severe PEP between the two groups [1.0% (1/104) VS 1.0% (1/100), χ2=0.001, P=0.978]. Conclusion:Compared with rectal administration of indomethacin suppository alone, the incidences of hyperamylasemia and PEP after difficult bile duct intubation during ERCP can be further reduced when it is combined with pancreatic duct stent placement.

Objective:To study the influencing factors of postoperative complications in patients with malignant biliary obstruction treated by endoscopic radiofrequency ablation(RFA).Methods:Data of patients with malignant biliary obstruction who underwent endoscopic RFA at the Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine from January 2010 to June 2021 were retrospectively analyzed. There were 62 males and 48 females, with age (74.1±11.1) years. Based on occurrence of postoperative complications, these patients were divided into the complication group ( n=18) and the control group ( n=92). Univariate and multivariate logistic regression analysis were used to analysis the influencing factors of complications. Results:RFA was successfully performed in 110 patients with malignant biliary obstruction, and the technical success rate was 100.0% (110/110). Postoperative complications occurred in 18 patients (16.4%), including 12 patients with of biliary tract infection (8 patients with acute cholangitis, 4 patients with acute cholecystitis) and 6 patients with acute pancreatitis. All these patients responded well to treatment. The proportion of patients who developed complications having associated diabetes, bile duct stenosis length >2.5 cm, fractional RFA for bile duct stenosis, and single stent drainage were significantly higher than those in the control group (all P<0.05). Multivariate logistic regression analysis showed that the risk of complications after endoscopic RFA was significantly increased in patients with diabetes ( OR=6.967, 95% CI: 1.256-38.658) and fractional RFA of bile duct stenosis ( OR=8.297, 95% CI: 1.526-45.122), while the risk of complications after multiple stents drainage ( OR=0.037, 95% CI: 0.008-0.169) was significantly decreased (all P<0.05). Conclusion:Diabetes and fractional RFA of bile duct stenosis were risk factors for complications after endoscopic RFA of malignant biliary obstruction. Multiple stents drainage was a protective factor. Better clinical attention should be paid to the patients with high risk factors.

Objective:To evaluate the efficacy and safety of endoscopic papillectomy (EP) combined with endobiliary radio frequency ablation (RFA) for duodenal papilla tumor with intraductal biliary infiltration.Methods:Data of 12 patients with histologically confirmed duodenal papilla tumor combined with intraductal biliary infiltration treated by EP with RFA from February 2013 to February 2019 were retrospectively analyzed. Clinical characteristics,endoscopic features, treatment efficacy and postoperative complications of patients were reviewed and recurrence was followed up.Results:The median diameter of lesions measured by endoscopic ultrasound was 18.5 mm×15.5 mm, and the length of intrabiliary invasion was 14.1±5.8 mm. EP combined with RFA was successfully performed in all patients with a technical success rate of 100%. Postoperative pathology showed adenocarcinoma in 5 patients, adenoma with high-grade intraepithelial neoplasia in 6 patients, and adenoma with low-grade intraepithelial neoplasia in 1 patient. Patients received mean 4.1±1.6 times of ERCP with intraductal biopsy during a mean follow-up period of 28.5±10.4 months. Recurrence occurred in 2 patients at 14 and 20 months respectively, both were adenocarcinoma.Conclusion:EP combined with RFA is effective and safe for duodenal papilla tumor with intraductal biliary infiltration. However, given the risk of recurrence, close surveillance is recommended.

Objective:To evaluate the efficacy and safety of lumen-apposing metal stent (LAMS) for the treatment of pancreatic walled-off necrosis (WON).Methods:A retrospective cohort study was performed on data of 43 consecutive patients with pancreatic WON who underwent endoscopic ultrasound-guided drainage by LAMS or plastic stents (PS) in Hangzhou First People's Hospital from December 2010 to June 2020. According to the type of stent used, the patients were divided into the LAMS group ( n=16) and the PS group ( n=27). The technical success rate, the clinical success rate, the operation time, the session of endoscopic necrosectomy, the stent insertion time and adverse events were compared between the two groups. Results:All 43 patients were successfully stented, indicating a technical success rate of 100% in both groups. For the LAMS group, the clinical success rate, the operation time, the session of endoscopic necrosectomy, the stent insertion time and overall incidence of adverse events were 75.0% (12/16), 26.0 (19.1, 39.8) min, 0.5 (0, 2.0) times, (41.3±28.4) days, and 43.7% (7/16), respectively, whereas these indices of the PS group were 37.0% (10/27) ( χ2=5.795, P=0.016), 31.0 (26.0, 48.0) min ( Z=1.221, P=0.222), 0 (0, 0) times ( Z=2.245, P=0.025), (176.1±99.1) days ( t=5.187, P<0.001) and 14.8% (4/27) ( χ2=8.893, P=0.064), respectively. Conclusion:LAMS placement is safe and effective for the treatment of pancreatic WON with a higher clinical success rate compared with PS. However, it requires more endoscopic intervention.

Objective:To evaluate the safety, efficacy and performance of disposable cholangiopancreatoscope in the diagnosis and treatment of bile duct diseases.Methods:A total of 20 subjects were selected and 16 subjects were enrolled in the prospective and exploratory clinical study which were performed in the Digestive Endoscope Center of Hangzhou First People's Hospital Affiliated to Zhejiang University School of Medicine from July 2021 to August 2021. The disposable cholangiopancreatoscope was used to diagnose bile duct diseases in routine endoscopic retrograde cholangiopancreatography. Biopsies were performed in cases where malignancy was considered. The use related indexes and performance indexes of the instruments were analyzed.Results:Among the 16 patients, there were 6 cases of biliary space-occupying lesions, 6 cases of biliary calculi, and 4 cases of benign biliary stricture before operation. The success rate of the disposable insertion was 100.00% (16/16), and the success rate of observation was 100.00% (16/16). Three biliary space-occupying lesions diagnosed as malignant tumor under cholangiopancreatoscope were confirmed by pathology after operation. Diagnosis of other patients was consistent with preoperative diagnose, so no biopsy was conducted. The rate of positive feedback from operators in directional control was 81.25% (13/16), the image failure rate was 18.75% (3/16), and the rate of positive feedback for image clarity was 93.75% (15/16). In terms of clinical performance, the imaging quality of excellence was 93.75% (15/16), the flexible degree of excellence was 81.25% (13/16), and other indexes were all 100.00% excellence. During the period, there were no instrument defects, pancreatitis, perforation, bleeding or other instrument-related adverse events.Conclusion:The effectiveness, safety and performance indexes of domestic disposable cholangiopancreatoscope have reached the standards of clinical application with high pixel, integration, and portability. It's worthy of clinical recommendation.

To evaluate the clinical efficacy and safety of Hot AXIOS, a novel luminal metal stent with a cautery system guided by endoscopic ultrasound, for the treatment of infected pancreatic necrosis (IPN), 5 cases of IPN treated with endoscopic ultrasound-guided Hot AXIOS placement in Hangzhou First People's Hospital from December 2021 to January 2022 were retrospectively analyzed. The results showed that all 5 cases successfully completed the treatment, with 8-21 minutes of the operation time. The symptoms of abdominal pain and bloating on the first day after operation were significantly relieved, and the abdominal CT showed that the walled-off necrosis was significantly reduced. After 2-9 times of direct endoscopic necrosectomy, supplemented by antibiotics, patient's temperature and blood inflammatory indexes returned to normal, the cavity was reduced and necrosis was removed. The Hot AXIOS stent was indwelled for 12-40 days and then removed. After 25-113 days of the follow-up, all patients survived without recurrence. Preliminary results suggest that endoscopic ultrasound-guided Hot AXIOS placement is safe and effective for the treatment of IPN.