An Early Prospective Clinical Study to Evaluate the Safety and Performance of the Versius Surgical System in Robot-Assisted Cholecystectomy.

OBJECTIVE: The aim of this study was to demonstrate the ability of the Versius Surgical System to successfully and safely complete cholecystectomy. BACKGROUND: The system has been developed in-line with surgeon feedback to overcome limitations of conventional laparoscopy to enhance surgeon experience and patient outcomes. Here we present results from the cholecystectomy cohort from a completed early clinical trial, which was designed to broadly align with Stage 2b of the Idea, Development, Exploration, Assessment, Long-term follow-up framework for surgical innovation. METHODS: Procedures were performed between March 2019 and September 2020 by surgical teams consisting of a lead surgeon and operating room (OR) assistants. Male or female patients aged 18 years and over and requiring cholecystectomy were enrolled. The primary endpoint was the rate of unplanned conversion from robot-assisted surgery to conventional laparoscopic or open surgery. Adverse events (AEs) and serious AEs were adjudicated by video review of the surgery and patient study reports by an independent Clinical Expert Committee. RESULTS: Overall, 134/143 (93.7%) cholecystectomies were successfully completed using the device. Of the 9 (6.3%) conversions to another surgical modality, 7 were deemed to be related to the device. A total of 6 serious AEs and 3 AEs occurred in 8 patients (5.6%), resulting in 4 (2.8%) readmissions to hospital within 30 days of surgery and 1 death. CONCLUSIONS: This study demonstrates cholecystectomy performed using the device is as safe and effective as conventional laparoscopy and supports the implementation of the device on a wider scale, pending instrument modifications, in alignment with Idea, Development, Exploration, Assessment, Long-term follow-up Stage 3 (Assessment).

Pre-transplant optimization by Molecular Adsorbent Recirculating System in patients with severely decompensated chronic liver disease.

BACKGROUND: The outcome of liver transplantation (LT) is influenced by the recipient's clinical condition. In a retrospective observational study, we evaluated the role of pre-LT Molecular Adsorbent Recirculating System (MARS) treatment in improving the clinical status and thereby the outcome of patients with chronic liver disease and severe hepatic decompensation. METHODS: Between March 2002 and September 2006, 70 patients with end-stage chronic liver disease underwent living-donor LT (LDLT). Of these, 9 (13%) patients with severely decompensated liver function (serum bilirubin> 350 micromol/L [20 mg/dL] and/or hepatic encephalopathy > or = grade 2) received pre-LT MARS treatment. RESULTS: The median MELD score was 33 (range, 26-47). A median of 2 (range, 1-6) sessions (8 hour/session) of MARS dialysis was performed per patient. MARS treatment was associated with reduction in serum bilirubin, creatinine and ammonia levels and no procedure-related complications. CONCLUSION: Pre-LT MARS is well tolerated and results in reduction of jaundice and improvement in renal function and may be useful in the management of patients with severe hepatic decompensation.

Cronkhite Canada syndrome complicated by pulmonary embolism-A case report.

INTRODUCTION: Cronkhite Canada Syndrome (CCS) is a rare syndrome, described in 1955 by Americans, Leonard Wolsey Cronkhite and Wilma Jeanne Canada in the New England Journal of Medicine [1]. About 450 cases have been reported. Complications, like malignant transformation, unprovoked thromboembolism is known. Since there is wide variability in medical presentation, no definitive diagnostic and treatment protocol s have been set. The mortality remains at 55%. CASE PRESENTATION: We report a case of a 50 year old male patient presenting with diarrhea, weight loss, abdominal pain, ectodermal features. His upper (UGI) and lower Gastrointestinal (LGI) endoscopy showed multiple polypoidal and carpet like lesions in fundus, body and antrum of stomach. Videocolonoscopy showed multiple sessile and pedunculated polyps. Multiple biopsies were taken, proving malignancy. Because of poor nutrition, total parenteral nutrition was given for four weeks. After nutritional optimization, he underwent laparoscopic assisted subtotal colectomy. His post-operative course was complicated by the occurrence of pulmonary embolism and anastomotic leak. DISCUSSION: CCS is an ailment of unknown pathophysiology. Considering what is known so far, patients suffering from CCS are at highest risk of thromboembolic episodes. This seems to be irrespective of surgical intervention. Patients of CCS should have thromboembolic prophylaxis started as soon as a diagnosis is made. They should have thrombophilia profile, fibrinogen level and Factor 8 tested before any intervention is planned. CONCLUSION: If CCS presents with a surgical indication, namely malignancy, the patient should be categorized as highest risk for thromboembolic complications and both mechanical and pharmacological prophylaxis be instituted.

Longterm survival after extended resections in patients with gallbladder cancer.

BACKGROUND: Surgery is the treatment of choice for gallbladder cancer, but the extent of resection and its benefits remain unclear. STUDY DESIGN: Survival analysis of 42 patients who underwent extended resections for gallbladder cancer was performed. Resections were labeled R0 (curative) or R1 (noncurative) based on histopathologic evaluation. Survival curves were constructed using the Kaplan-Meier method, and survival data were analyzed by univariate and multivariate analyses to identify factors associated with longterm (>2 years) survival. RESULTS: R0 status was achieved in 18 patients (43%): 100%, 100%, 45%, and 0% in stages I, II, III, and IV, respectively. Patients with R0 resections had a significantly better survival than those with R1 resections (median 25.8 months versus 17.0 months; p = 0.03). R0 status was achieved in only 3 of 20 patients (15%) with node positive (N1) disease compared with 14 of 17 patients (82%) with node negative (N0) disease. Patients with N0 disease had a significantly better survival than those with N1 disease (median not reached versus 17 months; p = 0.01). None of the patients with N1 disease survived 5 years; 5-year survival for N0 patients was 58%. Adjuvant therapy did not have a significant effect on survival. CONCLUSIONS: In patients with gallbladder cancer, R0 status could be achieved in only 43% of patients undergoing extended resections. R0 status and N0 disease were associated with better longterm survival.

Early gallbladder cancer.

BACKGROUND: The majority of patients with gallbladder cancer (GBC) have advanced disease at the time of diagnosis and are unresectable. Longterm survival is usually seen in a subset of patients with early GBC (EGBC)-cancer confined to the mucosa (pT1a) and muscularis (pT1b). Management guidelines of EGBC are not yet defined and are controversial. The purpose of this article is to evaluate the diagnostic aspects and effects of resectional procedures on survival outcome in patients with EGBC. STUDY DESIGN: EGBC was defined as cancer confined to the mucosa (pT1a) or muscularis (pT1b) according to the TNM classification. Clinicopathological details and survival data of 14 patients who had EGBC were analyzed. There were 9 women and 5 men, with a mean age of 60 years. RESULTS: A definite preoperative diagnosis was possible in only three patients and three patients were diagnosed at operation; the majority of patients were diagnosed incidentally after cholecystectomy for associated gallstones. Two patients underwent extended cholecystectomy and 12 patients underwent simple cholecystectomy. Two patients had pT1a and 12 had pT1b lesions. Mean (SD) survival was 71.5 (12.2) months and median survival was 42 months. There were five treatment failures with locoregional recurrence and death; all with pT1b tumors were treated by simple cholecystectomy. Cumulative 1-, 3-, and 5-year survival was 92%, 68%, and 68% respectively [corrected]. CONCLUSIONS: Simple cholecystectomy is an adequate treatment only for mucosal GBC. Patients with pT1b tumors require extended cholecystectomy. Incidental GBC extending up to the muscularis merits early reoperation for completion of extended cholecystectomy, which offers the only chance of cure.

Dieulafoy's lesion of duodenum: a case report.

BACKGROUND: Dieulafoy's lesion is an uncommon but important cause of recurrent upper gastrointestinal bleeding. Extragastric location of Dieulafoy's lesion is rare. We report two cases of Dieulafoy's lesion of the duodenum and discuss the management of this extremely uncommon entity. CASE PRESENTATION: Two cases of massive upper gastro-intestinal bleeding in young adults due to Dieulafoy's lesion of the duodenum are reported. Endoscopic diagnosis was possible in both cases. Hemostasis was achieved successfully by endoscopic adrenaline injection. The endoscopic appearance, pitfalls in the diagnosis and management of this rare lesion are discussed. CONCLUSIONS: Endoscopic diagnosis of extragastric Dieulafoy's lesion can be difficult because of the small size and obscure location of the lesion. Increased awareness and careful and early endoscopic evaluation following the bleeding episode are the key to accurate diagnosis. Adrenaline injection is one of the important endoscopic modalities for control of bleeding.

Bouveret's syndrome--an unusual cause of spontaneous resolution of gastric outlet obstruction.

Gastric outlet obstruction due to a gallstone impacted in the duodenal bulb (Bouveret's syndrome) is a rare complication of gallstones. We report a 47-year-old man with this syndrome in whom the impacted stone migrated uneventfully.

Large Brunneroma presenting with bleeding.

Brunner's gland adenoma (Brunneroma) is a rare entity. We report a patient who presented with severe anemia due to bleed from a large Brunneroma arising from the duodenal bulb, and was managed successfully by surgical excision of the tumor.

Spontaneous perforation--a rare complication of choledochal cyst.

We report a 2-year-old girl with spontaneous perforation of choledochal cyst. Preoperative diagnosis was possible by hepatobiliary scintigraphy. In view of emergency presentation and bile peritonitis, management was a staged procedure with peritoneal lavage and T-tube drainage of the biliary system, followed by excision of the cyst and Roux-en-Y hepatico-jejunostomy 3 months later.

Morphological changes in bile ducts following preoperative biliary stenting.

OBJECTIVES: To analyze the morphological changes in bile ducts following endobiliary stent insertion, and consequent technical problems encountered at surgery. METHODS: Data on bile duct morphology--gross (luminal diameter and wall thickness) and microscopic (histological changes in bile duct wall graded semiquantitatively)--and operative parameters related to bile duct dissection (grade of difficulty in dissection) were collected prospectively in 31 consecutive patients undergoing pancreatico-duodenectomy. These data were compared between patients who had undergone preoperative endoscopic biliary stent placement (n=17) and those who had not (n=14). RESULTS: Mean duration of stenting before surgery was 34 (range 10-120) days. Stented ducts were significantly narrower (luminal diameter 9 [7-12] mm vs. 17.5 [8-23] mm; p=0.0001) and had thicker walls (2.3 [1.3-3.5] mm vs. 1.85 [0.8-2.2] mm; p=0.004) compared to non-stented ones. On microscopy, stented ducts had advanced grades of submucosal gland hypertrophy, fibrosis and inflammatory cell infiltrate. Difficulty in bile duct dissection was encountered more often in patients who had been stented than in those without stents, though the difference was not statistically significant. CONCLUSION: Endobiliary stent placement results in significant morphological and fibroproliferative inflammatory changes in bile ducts, making dissection difficult.