Modified vagus nerve-preserving versus conventional laparoscopic splenectomy and azygoportal disconnection for cirrhotic portal hypertension : a prospective randomized controlled trial

Objective:To investigate the clinical efficacy of modified vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection (MVLSD) versus conventional laparoscopic splenectomy and azygoportal disconnection (CLSD) for cirrhotic portal hypertension.
Methods:The prospective randomized controlled study was conducted. The clinicopathological data of 70 patients with cirrhotic portal hypertension who were admitted to Clinical Medical College of Yangzhou University from April 2018 to February 2019 were collected. Patients were divided into two groups based on a random table. Patients undergoing CLSD were allocated into conventional group, and patients undergoing MVLSD were allocated into modified group, respectively. Observation indicators: (1) intraoperative and postoperative situations; (2) follow-up. Follow-up was conducted by telephone interview, outpatient and inpatient examination. Patients were followed up once every 3 months to detect upper digestive rebleeding, gastric retention, postprandial fullness and diarrhea. Electronic gastroscopy was performed on patients at postoperative 1, 6, 12 months. Endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm. The follow-up was up to February 2020. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were represented as M (range). Count data were described as absolute numbers, and comparison between groups was analyzed using the chi-square test or Fisher exact probability.
Results:A total of 70 patients with cirrhotic portal hypertension were selected for eligibility, including 51 males and 19 females, aged (52±12)years, with a range from 22 to 78 years. There were 35 and 35 patients in conventional group and modified group, respectively. One patient withdrew from the study. (1) Intraoperative and postoperative situations: operation time, volume of intraoperative blood loss, cases with intraoperative transfusion, cases with conversion to open laparotomy were (160±26)minutes, (76±104)mL, 0, 1 of the conventional group, versus (135±27)minutes, (65±68)mL, 1, 0 of the modified group, respectively. There was a significant difference in the operation time between two groups (t=-3.946, P<0.05). There was no significant difference in the volume of intraoperative blood loss between the two groups (t=-0.562, P>0.05), and there was also no significant difference in the intraoperative blood transfusion or conversion to laparotomy between the two groups (P>0.05). Neither group had emergency operation for bleeding. Caes with postoperative pancreatic fistula, pulmonary infection, abdominal infection and cases with portal vein thrombosis during postoperative 7 days, duration of hospital stay were 2, 1, 1, 16, (9.5±1.4)days of the conventional group, versus 1, 0, 0, 15, (9.3±1.4)days of the modified group, respectively. There was no significance difference in the postoperative pancreatic fistula, pulmonary infection or abdominal infection between two groups (P>0.05). There was no significant difference in the portal vein thrombosis or duration of hospital stay between the two groups (x²=0.123, t=-0.821, P>0.05). Patients with postoperative complications were cured after symptomatic and support treatment. No incision complication or gastric fistula occurred in either group. (2) Follow-up: all patients were followed up for 12 months. During the follow-up, gastric retention, diarrhea, abdominal distension and gastrointestinal rebleeding occurred in 31, 25, 27 and 3 of 34 patients in the conventional group, and the above complications occurred in 3, 3, 4 and 4 of 35 patients in the modified group, respectively. There was no significant difference in the gastrointestinal rebleeding between two groups (P>0.05). There were significant differences in the gastric retention, diarrhea or abdominal distension between two groups (x²=47.083, 30.180, 32.215, P<0.05). The albulin level at postoperative 12 months and esophageal varices diameter at postoperative 1 month were (44±5)g/L and (7.4±3.0)mm of the conventional group, versus (49±3)g/L and (7.7±2.7)mm of the modified group, respectively. There was a significant difference in the albulin level at postoperative 12 months between the two groups (t=5.365, P<0.05), while there was no significant difference in the esophageal varices diameter at postoperative 1 month (t=0.483, P>0.05).
Conclusion:MVLSD is a technically feasible and safe procedure in the treament of cirrhotic portal hypertension, which can not only simplify the process and shorten operation time, but also effectively reduces postoperative digestive system complications and improve quality of life. Trial Registration: this study was registrated at ClinicalTrial.gov in United States with the registration number of NCT03396796.