Achalasia in the Elderly: Diagnostic Approach and a Proposed Treatment Algorithm Based on a Comprehensive Literature Review

Achalasia is not uncommonly diagnosed in elderly patients and its incidence and prevalence are growing in this population. However, a scarcity of studies has assessed the typical pathophysiological and clinical features of the disease as well as the effectiveness and safety of the various therapeutic options in elderly populations. Botulinum toxin injection has been used for achalasia treatment since 1994 and is traditionally considered the preferred treatment for fragile elder patients. However, recently more evidence has become available regarding the safety and effectiveness of pneumatic balloon dilation (BD), laparoscopic Heller myotomy (LHM) and per-oral endoscopic myotomy (POEM) in elderly patients with achalasia. In the current review we present the current literature on this topic with a focus on the clinical presentation of achalasia in the elderly and manometric features thereof, as well as summarize the effectiveness and safety of the various therapeutic options. Furthermore, we propose a practical management algorithm as a means to guide the treatment of future cases. We recommend that a conservative/BTI approach should be adopted in the fragile unfit patient. In the elderly fit patient, the treatment decision should be based on the achalasia type, patient preference and the available expertise, similar to the approach adopted for the non-elderly population.

Non-psychiatrist prescriptions within the Brazilian National Health System represents a risk to patients in the use of psychotropic pharmacotherapies

This cross-sectional study collected data from the Brazilian National Health System (NHS) patients’ that filled their psychotropic prescriptions in NHS owned pharmacies. The study aimed to identify oversights in psychotropic prescriptions leading to insecure therapeutic. Patients in use of at least one psychotropic drug in 12 months were identified by a retrospective data search and considered for the study. After examining 15,001 patients in use of psychotropic medicines, 7,440 met the inclusion criterion. The majority of patients were women (67.1%), 54.2% of prescriptions analysed over the studied period presented multiple medicines including one psychotropic, and 54.7% cursing with psychotropic monotherapy. In 92.7% of cases, only one medicine was dispensed and prescriptions from psychiatrists represented only 17.6% of cases. In terms of safety, 9.5% of patients had at least one potential drug interaction of clinical significance, and 71.5% of elder patients had at least one drug that was potentially inappropriate for their age group use. These findings suggest urgency in integrating patients’ medical records information to pharmacotherapy history at the pharmacy computer technology applied for dispensing, reducing harm to patients in the use of psychotropic drugs.

Allogeneic Stem Cell Transplantation in Patients Aged ≥70 Years: Epidemiology, Outcomes, and Risk Factors Based on the German Registry for Stem Cell Transplantation (DRST)

Introduction. Malignant diseases treated with allogeneic hematopoietic stem cell transplantation (alloHSCT) predominantly occur beyond the 7 th decade of life. Numerical age per se is not regarded an adverse risk factor in alloHSCT. In an aging society, interventions historically deemed high risk are increasingly used in elder patients. Methods. Epidemiology, outcomes and risk factors of patients aged ≥70 years undergoing alloHSCT in Germany 1999-2019 and registered with the DRST/EBMT database were analyzed retrospectively. Baseline patient, disease, and transplant data were collected from MED-A forms. Centers were contacted to provide additional treatment and follow-up information. Results. Between 1999 and 2019, 1648 patients aged ≥70 years (median 72, range 70-79.7; 585 female) were transplanted in 50 German centers. More than 90% of all patients were transplanted 2010-2019. Centers transplanted between 2 and 192 patients, with 14 centers contributing <10 and 4 centers contributing >100 patients each. Most patients suffered acute leukemia (1084, 65.8%) or MDS/MPN (410, 24.9%). Karnofsky index before start of conditioning was 100% (n=230, 14%), 90% (n=651, 39.5%), 80% (n=480, 29.1%), 70% (n=94, 5.7%), <70% (n=55, 3.3%). Myeloablative conditioning was chosen in 25.6%. Total body irradiation was used for 305 patients (18.6%). Conditioning contained antithymocyteglobulin in 49.6%. Donors were unrelated for 85.5%. Median donor age was 37 (18-79) years. Patient CMV IgG was positive in 63.1% and the constellation 'negative donor, positive patient' was present in 19.9%. Median overall survival (OS) and disease free survival (DFS) was 408/ 344 days. With a median follow up of 536 days for surviving patients, Kaplan Meier estimates of OS/ DFS were 52.6%/ 48.5% and 40.9%/ 38.6% at 1 and 2 years. In a competing risk analysis, cumulative incidence of non-relapse-mortality (NRM)/ relapse (RI) was 22.2%/ 29.3% at 365 days. Frequency of acute graft versus host disease (GvHD) II-IV was 25.1% and chronic limited/ extended GvHD 11.7%/ 14.8%. Karnofsky performance score, CMV IgG matching, acute and chronic GvHD and stem cell source showed a prognostic impact on OS, DFS, RI and/ or NRM (Table 1). Underlying disease did not impact outcome, neither did age amongst patients at an age of 70-80 years. To compare with outcome in the decade below (60-69 years), an analysis after matching for underlying disease, CMV relation, and Karnofsky index included 2728 patients (each 1364 patients 60-69 and ≥70 years of age). For each year of life, univariate HR for OS and DFS were 1.01 [95%CI 1.001-1.023, p=0.035] and 1.01 [95%CI 0.99-1.02, p=n.s.], respectively, in this matched-pair analysis. The cumulative HR (OS, DFS) for both age groups was 1.16 [95%CI 1.05-1.28, p<0.01] and 1.13 [95%CI 1.02-1.24, p=0.016] for patients ≥70 years. Conclusion. AlloHSCT is increasingly used to treat elder patients in Germany with a sharp increase during the last decade. Age per se is a modest adverse risk factor for adult patients after alloHSCT with slightly increased mortality in patients 70-80 versus those at 60-69. Further research might concentrate on patient selection and further reduction of procedural toxicity. Figure 1 Figure 1. Disclosures Schetelig: Roche: Honoraria, Other: lecture fees; Novartis: Honoraria, Other: lecture fees; BMS: Honoraria, Other: lecture fees; Abbvie: Honoraria, Other: lecture fees; AstraZeneca: Honoraria, Other: lecture fees; Gilead: Honoraria, Other: lecture fees; Janssen: Honoraria, Other: lecture fees . Einsele: Janssen, Celgene/BMS, Amgen, GSK, Sanofi: Consultancy, Honoraria, Research Funding. Stelljes: Pfizer: Consultancy, Research Funding, Speakers Bureau; Medac: Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Celgene/BMS: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; MSD: Consultancy, Speakers Bureau; Kite/Gilead: Consultancy, Speakers Bureau. Dreger: AbbVie: Consultancy, Speakers Bureau; Bluebird Bio: Consultancy; Novartis: Consultancy, Speakers Bureau; Janssen: Consultancy; AstraZeneca: Consultancy, Speakers Bureau; Gilead Sciences: Consultancy, Speakers Bureau; BMS: Consultancy; Riemser: Consultancy, Research Funding, Speakers Bureau; Roche: Consultancy, Speakers Bureau. Wulf: Takeda: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Clinigen: Consultancy, Honoraria. Scheid: Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Honoraria; Roche: Consultancy; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees. Bethge: Novartis: Consultancy, Honoraria, Speakers Bureau; Kite-Gilead: Consultancy, Honoraria, Speakers Bureau; Miltenyi Biotec: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Celgene: Consultancy, Honoraria, Speakers Bureau.

Prevalence and Risk Factors of Antibodies to Class I and II Human Leukocyte Antigens in Haploidentical Allograft Candidates: A Prospective Study on 3805 Subjects

The aim of this study is to investigate the prevalence and risk factors of anti-human leukocyte antigen (HLA) antibodies in haploidentical candidates. This study was completed at Peking University People's Hospital, Beijing China. We performed a prospective analysis of patients with hematological diseases concerning the prevalence and risk factors of anti-HLA antibodies. Patients were enrolled between July 2015 - December 2019. Serum was collected for PRAs test within 1 month before haploidentical transplantation. The risk factors, such as age, sex, total transfusion, red blood cell (RBC) transfusion, platelet (PLT) transfusion, pregnancy, disease duration and diagnosis were collected. Univariate and multivariate logistic regression analyses were performed to evaluate the risk factors of anti-HLA antibodies. Six hundred and eighty (17.9%) patients were positive for panel reactive antibodies (PRA)-class I, 360 (9.5%) for class II, 768 (20.2%) class I or II, and 272 (7.1%) positive for class I and II both. Multivariate analysis indicated that female was related to higher risk of having PRAs for class I (P = 0.011), class I or II (P = 0.009), anti-HLA-A (P = 0.015), anti-HLA-DP (P = 0.048) and also for having higher mean fluorescence intensity (MFI) (2000 or more) of PRAs in class I (P = 0.020) and class I or II (P = 0.005). Compared to patients with myelodysplastic syndrome (MDS), patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), aplastic anemia (AA) had a lower incidence for PRAs in class I, class II, class I or II, class I and II, anti-HLA-A. anti-HLA-B, anti-HLA-C, anti-HLA-DQ, anti-HLA-DR, anti-HLA-DP (Table 1). Prior pregnancy was a risk factor for PRAs (P < 0.001), and no previous pregnancy group having lower MFI of PRAs in class I (P = 0.001) and class I or II (P = 0.004). PLT transfusion (more than 4 times) rleted with a higher prevalence of PRAs (P < 0.001), and also had a higher MFI of PRAs in class II (P < 0.001), class I and II (P < 0.001). Patients with RBC transfusion (more than 3 times) had a higher prevalence of PRAs in class I (P = 0.001), class II (P = 0.029), class I or II (P < 0.001), anti-HLA-A (P = 0.001), anti-HLA-B (P < 0.001), anti-HLA-C (P = 0.007), anti-HLA-DQ (P < 0.001) and anti-HLA-DR (P = 0.011). In addition, diseases duration (8 months or more) was also associated with higher MFI of PRAs in class I (P = 0.023) and class I or II (P = 0.004). Subgroup analysis showed that 11.7% of pediatric patients were positive for PRAs in class I; 19.2% of adults, 17.9% of elder patients; 12.4% of males; 26.1% of females; 21.0% of patients with AML; 10.5% of patients with acute lymphoblastic leukemia (ALL); 18.9% of patients with AA; 30.3% of patients with MDS; 16.6% of patients with other hematological diseases. The positive rate of class II PRAs in children was 4.3%; 11.1% for adults; 9.5% for elder patients; 5.5% for males; 15.4% for females; 11.4% for patients with AML; 5.2% for patients with ALL; 10.3% for patients with AA; 17.2% for patients with MDS; 6.6% of patients with other hematological diseases. Multivariate analysis showed that, in children, PLT transfusion and diagnosis were the two main risk factors of PRAs in class I and class II (P < 0.001, P = 0.017). In adults, diagnosis (P = 0.003), transfusion (P < 0.001) and pregnancy (P < 0.001) were the three main factors associated with PRAs in class I and transfusion (P < 0.001) and pregnancy (P < 0.001) were the two main factors associated with PRAs in class II. In males, PLT transfusion (P < 0.001) and diagnosis (P < 0.001) were the two main factors associated with PRAs in class I and class II. In ALL subgroup, gender (P = 0.026, P = 0.048), pregnancy (P < 0.001) and transfusion (P < 0.001) were the three main factors associated with PRAs in class I and II. In AA subgroup, gender (P = 0.004) and PLT transfusion (P < 0.001) were risk factors for class I PRAs, pregnancy (P = 0.008) and PLT transfusion (P = 0.003) were risk factors for class II PRAs. In elder patients, females, AML, MDS and other diseases subgroup, transfusion and pregnancy were the two main factors associated with PRAs in class I and class II. Our results indicated that female sex, diagnosis, pregnancy, transfusion, disease duration were independent risk factors of anti-HLA antibodies in haploidentical allograft candidates, which provided evidence for best haploidentical donor selection. The risk factors of anti-HLA antibodies were different among total patients and those of cases in different subgroups. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Modified Intensive Induction Treatment for Elderly Acute Myeloid Leukemia Patients Based on Peripheral Blast Clearance Rate: A Phase II Single-Arm Study

Background Outcomes and prognosis of older patients with acute myeloid leukemia (AML) are fairly dismal and poor tolerance to regimens hinders treatment decision-making to expand to the greatest extent. Nevertheless, it is still indicated that a certain proportion of elder patients may benefit from intensive therapies [1], after which the insistent need for algorithms to select elder patients fit for intensive regimens has emerged. Based on the previous achievement, monitoring the peripheral blast clearance rate on the day 5 of induction chemotherapy (D5-PBCR) showed its promising value in younger patients [2]. Along with the increasingly important comprehensive geriatric assessment (CGA), we conducted this trial in fit elderly AML patients to confirm the non-inferior efficacy of modified intensive treatment on the basis of D5-PBCR. Materials and methods This multiple-center, single-arm, phase 2 trial of early intervention according to D5-PBCR results with modified "3+7" regimen was performed at Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Shanghai, China) and the other two hospitals in Shanghai. Patients aged 60-75 years were assessed via CGA and required to be fit for intensive chemotherapy. Eligible patients had newly diagnosed AML with more than 0·5% blasts detected in the peripheral blood and adequate end-organ function. The initial induction included idarubicin (6 mg/m² for 3 days) and cytarabine (100 mg/m² for 7 days). Peripheral blood specimens were collected before and on day 5 of induction and analyzed by multi-parameter flow cytometry to calculate the D5-PBCR. D5-PRCR (+) patients received extra IDA (6 mg/m² for 2 days) starting from induction day 6 with the absence of contraindications. Responders received another "2+5" regimens and at least two cycles of mediate dose cytarabine or even allogeneic stem cell transplantation, if eligible. The primary endpoint was composite complete remission (CR/CRi), and secondary endpoints were overall survival, event-free survival, early mortality, minimal residual disease after one cycle of induction, drug toxicity, and safety. The trial was registered in the Chinese Clinical Trial Register (ChiCTR-OPC-16008955). Results Between March 30, 2016, and June 30, 2021, a total of 120 eligible patients were enrolled in the trial (Fig.1). Fifty-nine (49.2%) patients were D5-PBCR (+), of which seventeen patients were ineligible for extra idarubicin due to severe infection or unstable hemodynamic parameters and one patient was lost to follow-up. None of the patients in the D5-PBCR (-) group discontinued induction due to adverse events, and three patients were lost to follow-up. The composite complete remission rate after one course of induction for all patients was 62.6% (62/99), with 65.5% (38/58) and 58.5% (24/41) for D5-PBCR (-) and D5-PBCR (+) groups, respectively (P=0.497). At a median follow-up of 24.3 months (95% CI 10.4-38.2), median overall survival (OS) was 20.0 months (95% CI 15.2-24.8) and 13.6 months (95% CI 9.8-17.4), and the median event-free survival (EFS) was 7.8 months (95% CI 2.5-13.1) and 6.6 months (95% CI 4.3-8.9), respectively (Fig.2). Neither the OS nor EFS showed significant differences between the two groups. The total 30-day mortality rate of the two cohorts was 6.8% (7/103). The median platelet recovery time (PLT>50×109/L) after induction therapy in CR/CRi was different between patients with D5-PBCR(-) and D5-PBCR(+) (22 days vs 26 days, P=0.000, Fig.2F). There was a trend but no significant difference in the recovery time of neutrophils (ANC>0.5×109/L) in two cohorts (21 days vs 23 days, P=0.025, Fig.2E). The incidence of adverse events during the first induction was comparable between the two groups and key adverse events of grade ≥3 included pneumonia(37%), sepsis (7%), and γ-glutamyl transpeptidase(GGT) increase (6%) in the entire cohort(Table.1). Conclusion: "3+7" regimen modified by the composition of D5-PBCR and CGA was safe and tolerable in fit older patients with AML. The efficacy and safety of induction were non-inferior compared with the results of existing trials, along with a relatively lower dose of IDA. We considered there may be reserved probability for combining other emerging drugs to challenge higher remission rate in fit AML with additional investigation. Keywords: acute myeloid leukemia; elderly; induction therapy; non-inferior; flow cytometry; D5-PBCR. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

EVALUATION OF C - REACTIVE PROTEIN AS A PROGNOSTICATOR OF THE COURSE OF COVID 19 DISEASE

Diagnosis of COVID 19 is based on clinical manifestations, history of exposure, positive CT scan findings and laboratory tests. Inflammation plays a key role in pathogenesis of COVID 19. CRP is an acute phase protein in the serum and is also a surrogate marker for the pro inflammatory cytokine IL 6. Significant rise in CRP indicates clinically relevant inflammation. Aim and Objectives: To analyse the CRP levels in COVID 19 infected patients and to validate CRP as an indicator of the severity of SARS CoV 2 infection. Materials and Methods: This retrospective study was carried out at Chettinad Hospital and Research Institute, a tertiary care hospital situated on the outskirts of Chennai, India, for a period of 4 months. A total of 10263 patients were tested for COVID-19 by RT PCR. Viral RNA Extraction was automated and SARS CoV2 RTPCR performed with ROTOR GENE Q(QIAGEN) using SD Biosensor Real Time PCR kit. The CRP levels were measured using QDx Instacheck Fluorescence immunoassay system, Indianapolis, IN. Results: Among 10263 patients, 2694 (26.2%) patients tested SARS CoV-2 positive. CRP levels were measured for 1472 SARS CoV 2 patients (including both OP and IP). Among them 745 (50.6%) patients were found to be CRP reactive. Of the CRP reactive patients, 7 patients (0.9%) were <18 years, 190 patients (25.5%) were between 18 - 45 years and 548 patients (73.5%) were >45 years. Of the 592 patients with elevated CRP levels, 167 patients were from ICU and 425 patients were from non-ICU. Highly elevated CRP levels of >100mg/L were found in 65% (n=109) of the COVID positive ICU patients and 23% (n=101) of the non-ICU patients. Increased CRP levels were noted in SARS CoV- 2 infected individuals. Elevated CRP was common among elder patients aged >45 years and in males. Conclusion This study concludes that the significant rise of CRP levels was noted in hospitalized SARS CoV 2 positive patients aged > 45 years. Thus, estimating the early rise of serum CRP levels in SARS CoV-2 patients is a well affordable and less invasive parameter to guide the clinicians that is readily available in all the health care centers.

Magnitude of hypothyroidism among patients of cholelithiasis in a tertiary care centre in rural West Bengal: a prospective study

Background: Cholelithiasis is a common pathology of the gall bladder affecting about 10 to 15% of the adults in western countries and 2 to 29% in India. More than 80% of the patients with cholelithiasis are asymptomatic. Hypothyroidism may cause gall stone formation due to the hyperlipidemia, motility disorders affecting the bile duct and sphincter of Oddi.Methods: This was a descriptive cross-sectional study conducted at Department of Surgery, Bankura Sammilani Medical College and Hospital, Bankura from March 2019 to February 2020 for duration of one and half year. The sample size was 54 and consecutive non-probability sampling technique was used for the sampling. All the collected data were recorded in a pre-designed proforma and analyzed in MS excel.Results: Out of 54-patients with cholelithiasis, 28% patients were from the age group 45-54 years.40% patients were hypothyroid pre-dominantly females. Among 30-female patients 11 (26.82%) were hypothyroid and among 11-male patients 2 (15.38%) were hypothyroid. Hypothyroidism in male and female was statistically significant.Conclusions: This study was introduced to determine the relationship between hypothyroidism and cholelithiasis. It was concluded that hypothyroidism was more common in female, obese and elder patients. The gender distribution of the hypothyroidism in patients with cholelithiasis was statistically significant while all other variables were statistically not significant.

Surgical management of chronic subdural hematomas through single-burr hole craniostomy: is it sufficient?

Background Symptomatic chronic subdural hematomas (CSDH) remain one of the most encountered forms of intracranial hemorrhages particularly in the elder patients, yet fortunately implies a good surgical prognosis. Burr hole evacuation under general anesthesia is the most commonly used neurosurgical technique for the management of CSDH. Clinical disagreement between many studies regarding the number of burr holes required to achieve the optimal surgical and clinical outcome has long existed. The objective of this study is to evaluate the prognosis and clinical outcome following the use of single-burr hole craniostomy technique in the aim of surgical evacuation of CSDH. Results This is a retrospective study of 30 patients, with symptomatic unilateral or bilateral CSDH managed by the authors strictly by single-burr hole evacuation with closed-system drainage on the corresponding site of the hematoma. Clinical outcome was then assessed at 1, 7, and 30 days after surgery using the Glasgow Coma Scale (GCS) and by comparing the Markwalder grade scale before surgery to 1 month following surgery; the pre- and post-operative radiological data, clinical neurological progress and the possible incidence of complications postoperatively were also recorded. Study duration was from August 2019 to October 2020. Our study included 18 (60%) male patients and 12 (40%) female patients. The main presenting symptom was altered level of consciousness noted in 29 (96.7%) patients; a history of a relevant head trauma was recorded in 11 patients (36.7%). The GCS showed a statistically highly significant improvement comparing the preoperative to the postoperative values throughout the follow-up intervals (p = 0.001); similarly, the Markwalder score significantly improved 1 month after surgery, where 17 (63%) patients were Markwalder grade 0, 9(33.3%) patients were grade 1, a single patient (3.7%) was grade 2, and none were Markwalder grade 3. Conclusion Our study concluded that single-burr hole craniostomy with closed-system drainage for the management of symptomatic CSDH would be a sufficient approach to achieve a good surgical outcome with a low complication rate. Larger series and further studies would be yet considered with longer follow-up periods.

The Effect of Mild Traumatic Brain Injury on Cerebral Microbleeds in Aging

A traumatic brain injury (TBI) induces the formation of cerebral microbleeds (CMBs), which are associated with cognitive impairments, psychiatric disorders, and gait dysfunctions in patients. Elderly people frequently suffer TBIs, especially mild brain trauma (mTBI). Interestingly, aging is also an independent risk factor for the development of CMBs. However, how TBI and aging may interact to promote the development of CMBs is not well established. In order to test the hypothesis that an mTBI exacerbates the development of CMBs in the elderly, we compared the number and cerebral distribution of CMBs and assessed them by analysing susceptibility weighted (SW) MRI in young (25 ± 10 years old, n = 18) and elder (72 ± 7 years old, n = 17) patients after an mTBI and in age-matched healthy subjects (young: 25 ± 6 years old, n = 20; aged: 68 ± 5 years old, n = 23). We found significantly more CMBs in elder patients after an mTBI compared with young patients; however, we did not observe a significant difference in the number of cerebral microhemorrhages between aged and aged patients with mTBI. The majority of CMBs were found supratentorially (lobar and basal ganglion). The lobar distribution of supratentorial CMBs showed that aging enhances the formation of parietal and occipital CMBs after mTBIs. This suggests that aging and mTBIs do not synergize in the induction of the development of CMBs, and that the different distribution of mTBI-induced CMBs in aged patients may lead to specific age-related clinical characteristics of mTBIs.

Prediction of post radical nephrectomy complications based on patient comorbidity preoperatively

Objectives: Comorbidity along with tumor and patient characteristics is taken into account when deciding for the surgical treatment of renal cell carcinoma (RCC). Comorbidity has also been used as an independent predictive factor for postoperative complications of several major urological procedures including radical nephrectomy for RCC. The aim of the present study was to objectively evaluate the association between comorbidity and postoperative complications after radical nephrectomy for RCC, using standardized systems to grade both comorbidity and severity of postoperative complications. Materials and methods: Clinicopathological data of 171 patients undergoing open radical nephrectomy for lesions suspected of RCC were prospectively recorded for a period of 3 years. Comorbidity was scored using the Charlson Comorbidity Index (CCI) while postoperative complications were graded according to the Clavien-Dindo system.Results: Patients were predominantly males (59.1%); their age ranged from 35 to 88 years (mean ± SD: 63.6 ± 11.9 yrs) with 50.8% of them being ≤ 65 yrs. CCI ranged from 0 to 8 with the majority (85.3%) scoring ≤ 2. The procedure was uncomplicated in 57.3% cases; 10 patients suffered major (grade III/IV) complications and 4 patients died within the 40 days postoperative period. CCI correlated with the manifestation of any postoperative complication, Clavien ≥ 1, OR (95% CI): 1.47 (1.09-1.96), p = 0.011 and the occurrence of severe complications, Clavien > 2. OR (95% CI): 1.29 (1.01-1.63), p = 0.038. Conclusions: The present prospective study showed that considerable complications occur in patients with major comorbidities. CCI is easily calculated and should be incorporated in preoperative consultation especially in cases of elder patients with severe comorbidity and favorable tumor characteristics where less invasive interventions or even active surveillance could be applied.