Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy.

STUDY PURPOSE: The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases. METHODS: The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection. RESULTS: Not applicable. CONCLUSION: DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR. TRIAL REGISTRATION: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).

Preoperative portal vein or portal and hepatic vein embolization: DRAGON collaborative group analysis.

BACKGROUND: The extent of liver resection for tumours is limited by the expected functional reserve of the future liver remnant (FRL), so hypertrophy may be induced by portal vein embolization (PVE), taking 6 weeks or longer for growth. This study assessed the hypothesis that simultaneous embolization of portal and hepatic veins (PVE/HVE) accelerates hypertrophy and improves resectability. METHODS: All centres of the international DRAGON trials study collaborative were asked to provide data on patients who had PVE/HVE or PVE on 2016-2019 (more than 5 PVE/HVE procedures was a requirement). Liver volumetry was performed using OsiriX MD software. Multivariable analysis was performed for the endpoints of resectability rate, FLR hypertrophy and major complications using receiver operating characteristic (ROC) statistics, regression, and Kaplan-Meier analysis. RESULTS: In total, 39 patients had undergone PVE/HVE and 160 had PVE alone. The PVE/HVE group had better hypertrophy than the PVE group (59 versus 48 per cent respectively; P = 0.020) and resectability (90 versus 68 per cent; P = 0.007). Major complications (26 versus 34 per cent; P = 0.550) and 90-day mortality (3 versus 16 per cent respectively, P = 0.065) were comparable. Multivariable analysis confirmed that these effects were independent of confounders. CONCLUSION: PVE/HVE achieved better FLR hypertrophy and resectability than PVE in this collaborative experience.

Treatment options for metastatic colorectal cancer in patients with liver dysfunction due to malignancy.

BACKGROUND: The survival of colorectal cancer patients is frequently determined by the extent of metastatic invasion to the liver; in cases of major involvement, therapeutic strategies are limited because the liver is necessary for drug metabolism. MATERIAL AND METHODS: We have reviewed articles about the pharmacokinetic profiles of each drug used in colorectal cancer patients with hepatic dysfunction to determine which of these treatments are most feasible. RESULTS: Some drugs appear to be feasible options for patients with hepatic insufficiency. Agents such as 5-fluorouracil and oxaliplatin, as well as monoclonal antibodies such as bevacizumab, cetuximab, and panitumumab, can potentially be used in these cases. On the other hand, irinotecan and regorafenib cannot be recommended because of the risk of increased toxicity. CONCLUSION: Treatment of patients with colorectal cancer and liver dysfunction represents a major challenge because the prognosis is usually very poor and alteration of liver function is normally an exclusion criterion in clinical trials. In this review, we present evidence regarding the use of each drug in patients with colorectal cancer and hepatic impairment.

Transanal endoscopic microsurgery for rectal tumours using a Single Incision Laparoscopic Port.

BACKGROUND: Transanal endoscopic microsurgery (TEM), first described by Buess enables a less aggressive approach of benign rectal lesions, or even early rectal cancer in a curative intent. MATERIALS AND METHODS: The SILS Port, initially designed for laparoscopic surgery, was successfully used for 20 TEM procedures in 16 patients. Local resection was sufficient in 15 procedures (benign tumours or pT1) out of 20, whereas 5 TEM operations required additional surgery: 3 rectal resections (pT1Nx, pT1sm3Nx and pT2N1) and 1 TEM revision (1 patient refused the rectal resection (pT1Nx). Postoperative complications following Dindo-Clavien were: grade II in 4 patients (pain: 2; fever: 1; bleeding: 1) and grade IIIb in 2 patients (bleeding). No long-term faecal incontinence was noted. CONCLUSION: TEM using the SILS Port is a safe and effective procedure for local resection of benign and certain malignant tumours. Using such a cheaper device, TEM procedure could be available in any operating theatre.

Splenic metastasis from gastrointestinal neoplasms: a review.

Spleen metastases from solid tumours are rather exceptional, especially for those located in the digestive tract. Although these lesions are usually associated with multivisceral disease at terminal stage, several cases of isolated lesions have also been described in the literature. Diagnosis of spleen lesions associated with multivisceral disease rarely influences patient's outcome. On the other hand, isolated, only-splenic lesions could be curatively treated, allowing physicians to obtain better patient's survival. The aim of this article is therefore to review and summarize a systematic search of all the literature in English based on a Medline search (Pubmed) carried out from January 2000 to February 2011, focusing on only-spleen lesions secondary to digestive tract cancers, and pointing out diagnostic and treatment challenges medical oncologists have to face in their clinical practice.

Laparoscopic ultrasonography as a good alternative to intraoperative cholangiography (IOC) during laparoscopic cholecystectomy: results of prospective study.

Intraoperative cholangiography (IOC), used routinely or selectively, is the standard method for bile duct imaging during cholecystectomy. Laparoscopic ultrasonography (LUS) has emerged as a possible, safe and quick alternative. This study examined the evolving use and the performance of these two methods as primary technique for routine bile duct imaging, so as to detect common bile duct stones (CBDS) and to prevent common bile duct injury (CBDI). A prospective database permitted to evaluate the results of the two methods in 968 consecutive cholecystectomies. Nine hundered and twenty five were performed by laparoscopy, 18 (1.9%) by laparotomy and 25 (2.6) necessitated a conversion. The systematic use of the IOC was gradually replaced by a systematic use of the LUS. The success to delineate and evaluate the CBD, the detection of a CBDS, any type of bile duct complication, especially of CBDI, were registered. All the CBDS suspected by LUS were controlled by IOC. The patients were followed during 1 and 6 months. Six hundred and eighty five IOC and 269 LUS were performed. The procedure was technically unsuccessful in 35 IOC (5.1%) (mainly due to difficulty in catheterising the cystic duct) and in 2 LUS (1%) (due to steatosis). Concerning the detection of CBDS, 31 were detected by IOC (4.5%) and 16 by LUS (6%). Five IOC were considered as false positive, 1 as false negative (sensitivity and specificity of 96,9 and 99,2%) and 1 LUS as false positive (sensitivity and specificity of 100 and 99,6%). Five CBDI were detected in the complete seria: 2 during the dissection before the IOC, 1 thermic injury, 1 late stenosis, 1 lateral stenosis by the cystic clip detected by LUS. However none of these CBDI could have been prevented by IOC. In our experience, in this prospective study, LUS has been certainly as effective as IOC as a primary imaging technique for bile duct. It permitted to detect CBDS with a high specificity and sensitivity, and CBDS and was not followed by an increase in CBDI.