Open versus laparoscopic gastrectomy for advanced gastric cancer: a propensity score matching analysis of survival in a western population-on behalf of the Italian Research Group for Gastric Cancer.

BACKGROUND: Oncologic outcomes after laparoscopic gastrectomy for advanced gastric cancer in the West have been poorly investigated. The aim of the present study was to compare survival outcomes in patients undergoing curative-intent laparoscopic and open gastrectomy for advanced gastric cancer in several centres belonging to the Italian Research Group for Gastric Cancer. METHODS: Data of patients operated between 2015 and 2018 were retrospectively analysed. Propensity Score Matching was performed to balance baseline characteristics of patients undergoing laparoscopic and open gastrectomy. The primary endpoint was 3-year overall survival. Secondary endpoints were 3-year disease-free survival and short-term outcomes. Multivariable regression analyses for survival were conducted. RESULTS: Data were retrieved from 20 centres. Of the 717 patients included, 438 patients were correctly matched, 219 per group. The 3-year overall survival was 73.6% and 68.7% in the laparoscopic and open group, respectively (p = 0.40). When compared with open gastrectomy, laparoscopic gastrectomy showed comparable 3-year disease-free survival (62.8%, vs 58.9%, p = 0.40), higher rate of return to intended oncologic treatment (56.9% vs 40.2%, p = 0.001), similar 30-day morbidity/mortality. Prognostic factors for survival were ASA Score ≥ 3, age-adjusted Charlson Comorbidity Index ≥ 5, lymph node ratio ≥ 0.15, p/ypTNM Stage III and return to intended oncologic treatment. CONCLUSIONS: Laparoscopic gastrectomy for advanced gastric cancer offers similar rates of survival when compared to open gastrectomy, with higher rates of return to intended oncologic treatment. ASA score, age-adjusted Charlson Comorbidity Index, lymph node ratio, return to intended oncologic treatment and p/ypTNM Stage, but not surgical approach, are prognostic factors for survival.

Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus.

BACKGROUND: Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)-a standardized group of outcomes important to key international stakeholders-that should be reported by future trials in this field. METHODS: Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized. RESULTS: Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and 'serious' adverse events. CONCLUSION: A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.

Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial.

BACKGROUND: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015, only retrospective studies have been published, all with inconsistent results. METHODS: ADiGe (Abdominal Drain in Gastrectomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, and readmission rate. Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in the control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to the patient and caregivers. DISCUSSION: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure. TRIAL REGISTRATION: Prospectively registered (last updated on 29 October 2020) at ClinicalTrials.gov with the identifier NCT04227951 .

Could fluorescence-guided surgery be an efficient and sustainable option? A SICE (Italian Society of Endoscopic Surgery) health technology assessment summary.

BACKGROUND: Indocyanine green fluorescence vision is an upcoming technology in surgery. It can be used in three ways: angiographic and biliary tree visualization and lymphatic spreading studies. The present paper shows the most outstanding results from an health technology assessment study design, conducted on fluorescence-guided compared with standard vision surgery. METHODS: A health technology assessment approach was implemented to investigate the economic, social, ethical, and organizational implications related to the adoption of the innovative fluorescence-guided view, with a focus on minimally invasive approach. With the support of a multidisciplinary team, qualitative and quantitative data were collected, by means of literature evidence, validated questionnaires and self-reported interviews, considering the dimensions resulting from the EUnetHTA Core Model. RESULTS: From a systematic search of literature, we retrieved the following studies: 6 on hepatic, 1 on pancreatic, 4 on biliary, 2 on bariatric, 4 on endocrine, 2 on thoracic, 11 on colorectal, 7 on urology, 11 on gynecology, 2 on gastric surgery. Fluorescence guide has shown advantages on the length of hospitalization particularly in colorectal surgery, with a reduction of the rate of leakages and re-do anastomoses, in spite of a slight increase in operating time, and is confirmed to be a safe, efficacious, and sustainable vision technology. Clinical applications are still presenting a low evidence in the literature. CONCLUSION: The present paper, under the patronage of Italian Society of Endoscopic Surgery, based on an HTA approach, sustains the use of fluorescence-guided vision in minimally invasive surgery, in the fields of general, gynecologic, urologic, and thoracic surgery, as an efficient and economically sustainable technology.

Factors influencing survival after hepatectomy for metastases from gastric cancer.

PURPOSE: To investigate clinical factors influencing the prognosis of patients submitted to hepatectomy for metastases from gastric cancer and their clinical role. METHODS: Retrospective multi-center chart review. We evaluated how survival from surgery was influenced by patient-related, gastric cancer-related, metastasis-related and treatment-related candidate prognostic factors. RESULTS: One hundred and five patients submitted to hepatectomy for metastases from gastric cancer, in the synchronous and metachronous setting of the disease. In 89 cases a R0 resection was achieved, while in 16 a R+ hepatic resection was performed. Adjuvant chemotherapy was administered to 29 patients. Surgical mortality was 1% and morbidity 13.3%. Median disease-free survival was 10 months, median overall survival was 14.6 months. Overall 1, 3, and 5-year survival rates were 58.2%, 20.3%, and 13.1%, respectively. Survival was influenced independently by the factor T of the gastric primary (p < 0.001), by the curativity of surgical procedure (p = 0.001), by the timing of hepatic involvement (p < 0.001) and by adjuvant chemotherapy (p < 0.001). T4 gastric cancer, R+ resection, synchronous metastases, and abstention from adjuvant chemotherapy were associated with a worse prognosis; T4 gastric cancer and R+ resections displayed a cumulative effect (p < 0.001). CONCLUSIONS: Our data show that R0 resection must be pursued whenever possible. Furthermore, in the synchronous setting, the coexistence of T4 gastric primaries and R+ resections suggests prudence and probably abstention from hepatectomy. Finally, a multimodal treatment associating surgery and chemotherapy offers the best survival results.

Laparoscopic total mesorectal excision for rectal cancer: experience of a single center with a series of 174 patients.

BACKGROUND: Laparoscopic total mesorectal excision for low rectal cancer is not considered a gold standard treatment due to the high conversion rate and the long operation time. METHODS: A retrospective review examined a surgical series of 174 laparoscopic low rectal resections involving total mesorectal excision (1995-2006), with particular reference to technical points as well as surgical and oncologic outcomes. Miles operations and partial mesorectal excisions were excluded. RESULTS: The cancer affected the low rectum in 110 cases and the medium rectum in 64 cases. A total of 68 patients were subjected to neoadjuvant radiochemotherapy. The anastomosis was mechanical for 83.3% of the cases and intersphinteric through the perineum for 16.6% of the cases. Protective ileostomy was performed in 112 cases. The conversion rate was 4.6%. The mesorectum remained intact in 91.6% of the cases and was partially interrupted in 15 of the cases. In no case was it totally discontinued. The postoperative morbidity rate was 16.7%, and the mortality rate was 0.57%. The incidence of anastomotic fistulas was 14.4%. The percentage was higher for males (18.6 vs 8.3%) and correlated with the low distance of the tumor from the anal verge (18.2 vs 7.8%) and the absence of a protection ileostomy (20.9 vs 10.7%). After an average follow-up period of 48.6 months (range, 24-149 months), six patients (3.44%) experienced a pelvic recurrence. The 5-year overall survival rate was 75.4%, and the disease-free survival rate was 61.9%. CONCLUSION: Laparoscopic total mesorectal excision for low rectal cancer is safe and effective, allowing surgical and oncologic outcomes similar to those reported for open surgery.

Liver transplantation exceeding UCSF criteria: case report of a late recurrence treated by surgery and review of the literature.

INTRODUCTION: Treatment of a recurrence of hepatocellular carcinoma (HCC) after liver transplantation. Surgery has seldom been considered in such a situation because HCC recurrences are generally considered as a systemic disease. PATIENT AND METHODS: We describe a 47-year-old male patient who underwent liver transplantation in October 1999 for HCC exceeding the Milan and University of California, San Francisco (UCSF), criteria. RESULTS: In 2007 (8 years after liver transplantation), the patient developed a cervical bone metastasis treated by surgery. In April 2008, HCC had disseminated to hepatic pedicle lymph nodes. An extended hepatic pedicle lymphadenectomy was then performed. Today, our patient is doing well, without signs of recurrence. DISCUSSION: The risk of developing a tumor recurrence is the main argument against expanding the UCSF criteria. In case of an HCC recurrence, various treatments ranging from a change in the immunosuppression regimen to chemotherapy have been proposed. Surgical treatment has rarely been envisaged in the treatment of HCC recurrences because of the technical difficulties and the frequent dissemination of cancer.

Traumatic lesions of the diaphragm. Our experience in 33 cases and review of the literature.

We reviewed 33 consecutive patients with diaphragmatic injuries. Twenty-nine were admitted in emergency conditions after blunt (22 patients) or penetrating injury, presenting shock, dyspnoea, coma or acute abdomen in 21 cases; major associated lesions were found in 23 patients. Four patients presented acute complications of visceral herniation 2, 4, 84 and 216 months after the trauma. The diagnosis was preoperative in 23 cases, intraoperative in 9; in one case it was missed at laparotomy, becoming evident the day after. The sensibility of preoperative chest x-ray and CT was 86% and 100% in presence of visceral herniation, 14% and 0% in absence of visceral hernia. The diaphragmatic repair was always obtained by direct suture, following 20 haemostatic procedures (liver, spleen, mesenterium) and two bowel resections. The mortality rate was 24.4%; the morbidity rate was 48%. Traumatic lesions of the diaphragm are generally expression of particularly severe trauma whose outcome is mainly influenced by the associated lesions. They are also correlated to specific morbidity and mortality, so the surgical exploration is mandatory whenever this injury is suspected, considering that the preoperative diagnosis relies on visceral dislocation. Associated lesions influence the surgical strategy but a direct suture is usually effective in preventing specific complications.

Retrospective histologic comparison of Helicobacter pylori infection in gastric carcinoma, ulcerous disease and non-ulcerous dyspepsia.

Although a number of epidemiological, biological and clinical studies have been published, the effective role of Helicobacter pylori infection in gastric carcinogenesis remains unclear. In the present work we retrospectively compared Helicobacter infection rate, by means of histologic examination of gastric bioptic samples, in 70 patients affected by gastric carcinoma, 70 with ulcerous disease and 70 with non-ulcerous dyspepsia. The analysis was carried out by a single pathologist. The differences between the 3 groups were not statistically significant. From our present and previously reported data, the Helicobacter infection cannot be considered per se a significant risk factor for malignant gastric disease and further studies are needed to evaluate the role of Helicobacter infection in the development of some preneoplastic conditions such as chronic atrophic gastritis and intestinal metaplasia.

[Distal pancreatic resection with splenic preservation for metastasis of renal carcinoma diagnosed 24 years later from the nephrectomy]. / Pancreasectomia distale con preservazione della milza per metastasi di carcinoma renale diagnosticato a 24 anni di distanza dalla nefrectomia.

Renal cell carcinoma is a malignant tumor with a singular biological behaviour, presenting in some reported cases very late metastases. This report describes a case of solitary pancreatic metastasis from kidney carcinoma, operated on 24 years before, that appears exceptional because of the long disease-free period after nephrectomy and the unusual metastatic site. The 73-year-old woman concluded the follow-up several years before; she presented aspecific abdominal pain and ultrasonographic examination and CT-scan revealed the presence of a mass in the pancreatic istmus. The mass was excised with splenic preservation and was diagnosed to be a pancreatic metastasis from clear cell renal carcinoma. We discuss the diagnostic and therapeutic features of this tumors. It appears important to obtain the diagnosis preoperatively, because good results may be obtained with surgery, justifying an aggressive surgical approach.

A surgical solution to extrahepatic portal thrombosis and portal cavernoma: the splanchnic-intrahepatic portal bypass.

Three cases of prehepatic portal vein thrombosis, complicated by the clinical manifestations of portal hypertension, were successfully treated by surgically created splanchnic-intrahepatic portal bypass. Two out of three patients had been previously submitted to liver transplantation. No significant morbidity was observed and long-term Doppler evaluations proved the patency of the venous grafts. Together with the technical aspects of the procedures, the possible role of this technique, primarily proposed by De Ville de Goyet in 1992, is discussed in relation to the available therapies for the extrahepatic portal vein thrombosis.

Is there an association between Helicobacter pylori cytotoxin Cag A seropositivity and risk for gastric cancer?

BACKGROUND: Since discovered in 1990, Cag A, a protein expressed by specific strains of Helicobacter pylori, was thought able to explain why only a few Helicobacter infected patients develop peptic diseases and gastric cancer. However, clinical trials provide discordant results. MATERIALS AND METHODS: In this study we evaluate Helicobacter pylori and Cag A seropositivity in 35 cancer affected patients, in 36 gastritis affected patients and in 40 healthy blood donors by means of two commercially available fluorescence enzyme-immunoessay (ELISA). RESULTS: Odds ratios determination strongly suggests that Cag A bearer Helicobacter strains play a pathogenetic role in gastric diseases (OR 4.23, 95% CI 3.22-5.24 for cancer versus healthy volunteers, OR 3.2, 95% CI 2.19-4.21 for gastritis versus asymptomatic patients), but is unable to demonstrate a direct carcinogenic activity (cancer-gastritis difference is not significant: OR 1.32, 95% CI 0.39-1.25). CONCLUSIONS: Cag A seropositivity can be considered a risk factor for peptic disease, and only indirectly for gastric carcinoma. The paper also discuss some sampling, laboratory and statistical bias that can explain a wide eterogenity of the results reported in the literature.