Abstract:Background and Aims Complex choledocholithiasis often coexists with stenosis of the ampulla of Vater, which increases the difficulty and complexity of treatment. If only the stones in the bile duct are removed without addressing the ampullary stenosis, the disease is prone to recurrence. Previously, most treatments involved the use of endoscopic retrograde cholangiopancreatography (ERCP) to guide the wire for sphincterotomy and stone extraction, followed by laparoscopic cholecystectomy. However, ERCP has limitations in handling complex cases. In response, our team pioneered a new method of treating choledocholithiasis combined with stenosis of the ampulla of Vater via a transabdominal approach. This study was performed to investigate the feasibility and efficacy of this method, aiming to provide a new therapeutic option for clinical practice.Methods A randomized controlled study was conducted with 120 patients treated at Chengdu Second People's Hospital from 2021 to 2023 for gallbladder stones and choledocholithiasis with stenosis of the ampulla of Vater. Patients were divided into an observation group and a control group, with 60 cases in each group. The observation group underwent laparoscopic cholecystectomy with choledochotomy for stone extraction, followed by retrograde guidance of duodenal papillary sphincterotomy through the opened bile duct, simultaneously treating gallbladder, bile duct stones, and stenosis of the ampulla of Vater. The control group underwent traditional ERCP approach for sphincterotomy, stone extraction, and laparoscopic cholecystectomy. Perioperative variables were collected for both groups and the surgical outcomes were compared.Results Among the 120 patients, 54 were male and 66 were female. There were no statistically significant differences between the two groups in terms of stone extraction success rate, intraoperative blood loss, postoperative 24-h total bilirubin, direct bilirubin, transaminases, white blood cell count, jaundice relief time, or incidence rates of bile leakage, retroperitoneal bleeding/infection, and severe pancreatitis (all P>0.05). The observation group had significantly shorter average operative time and postoperative hospital stay compared to the control group (98.67 min vs. 110.8 min, P<0.05; 3.81 d vs. 5.61 d, P<0.05). Additionally, the observation group had a significantly lower incidence of postoperative hyperamylasemia and/or hyperlipasemia and mild pancreatitis (1.67% vs. 25.00%, P<0.001; 0 vs. 10%, P=0.027).Conclusion The novel transabdominal approach is superior to the ERCP approach in terms of reducing surgery time and hospitalization time, and it carries a lower risk of postoperative mild pancreatitis and hyperamylasemia and/or hyperlipasemia. The stone extraction success rate is comparable to that of ERCP, making it a viable alternative treatment option.