Management of primary and renal hyperparathyroidism: guidelines from the German Association of Endocrine Surgeons (CAEK).

BACKGROUND AND AIMS: The purpose of this review is to provide updated recommendations for the surgical management of primary (pHPT) and renal (rHPT) hyperparathyroidism, formulating a new guideline of the German Association of Endocrine Surgeons (CAEK). METHODS: Evidence-based recommendations for the diagnosis and therapy of pHPT and rHPT were assessed by a multidisciplinary panel using PubMed for a comprehensive literature search together with a structured consensus dialogue (S2k guideline of the Association of the German Scientific Medical Societies, AWMF). RESULTS: During the last 20 years, a variety of new preoperative localization procedures, such as sestamibi-SPECT, 4D-CT, and various PET/CT procedures, were established for pHPT. High-resolution imaging, together with intraoperative parathyroid hormone (IOPTH) measurement, enabled focused or minimally invasive surgery to become the most favored surgical technique. Patients with pHPT and nonlocalizing imaging have a higher risk of multiglandular disease. Surgical therapy provides very high cure rates, with a clear relation to the surgeon's experience in parathyroid procedures. Reoperative parathyroidectomy, children with pHPT or familial forms, and parathyroid carcinoma are addressed and require special surgical expertise. A multidisciplinary team of experienced nephrologists, transplant, and endocrine surgeons should assess the diagnosis and treatment of renal HPT. CONCLUSION: Surgery is the only curative treatment for pHPT and should be considered for all patients with pHPT. For rHPT, a more selective approach is required, and parathyroidectomy is indicated only when conservative treatment options fail. In parathyroid carcinoma, the adequacy of local resection influences local disease control.

Surgery for Renal Hyperparathyroidism in the Era of Cinacalcet: A Single-Center Experience.

BACKGROUND AND AIMS: There are only few data on the influence of cinacalcet on the outcome of parathyroidectomy in patients with renal hyperparathyroidism. Indication and timing of surgery have changed since its introduction, especially with regard to kidney transplantation. Therefore, we retrospectively analyzed patients undergoing parathyroidectomy for renal hyperparathyroidism in our institution. MATERIAL AND METHODS: Between 2008 and 2015, 196 consecutive operations in 191 patients were analyzed. About 80 operations (41%) were performed in patients receiving cinacalcet compared with 116 operations (59%) in patients without cinacalcet. Clinical data, preoperative medication, pre- and postoperative laboratory values, type and details of surgery including complications, as well as cardiovascular complications and kidney transplantation with graft function were recorded. RESULTS: Demographical data were similar in patients with or without cinacalcet treatment. A total of 54% of patients received a kidney graft before or after parathyroidectomy. Pre- and postoperative parathormone levels were similar in both groups (preoperatively 755 vs 742 ng/L, postoperatively 50 vs 46 ng/L, p > 0.10), whereas patients with cinacalcet showed significantly lower calcium levels preoperatively (2.28 vs 2.41 mmol/L, p = 0.0002). There was no difference in recurrence or persistence of hyperparathyroidism, duration of surgery, hospital stay, or complication rate. Creatinine levels in patients with tertiary hyperparathyroidism were similar after 1-year follow-up. CONCLUSION: Cinacalcet did not influence outcome of patients with parathyroidectomy for renal hyperparathyroidism and can be safely offered to patients not responding to medical treatment.

[Possibilities and perspectives of hyperspectral imaging in visceral surgery]. / Möglichkeiten und Perspektiven der Hyperspektralbildgebung in der Viszeralchirurgie.

HyperSpectral Imaging (HSI) technology enables quantitative tissue analyses beyond the limitations of the human eye. Thus, it serves as a new diagnostic tool for optical properties of diverse tissues. In contrast to other intraoperative imaging methods, HSI is contactless, noninvasive, and the administration of a contrast medium is not necessary. The duration of measurements takes only a few seconds and the surgical procedure is only marginally disturbed. Preliminary HSI applications in visceral surgery are promising with the potential of optimized outcomes. Current concepts, possibilities and new perspectives regarding HSI technology together with its limitations are discussed in this article.

Surgical therapy of adrenal tumors: guidelines from the German Association of Endocrine Surgeons (CAEK).

BACKGROUND AND AIMS: Previous guidelines addressing surgery of adrenal tumors required actualization in adaption of developments in the area. The present guideline aims to provide practical and qualified recommendations on an evidence-based level reviewing the prevalent literature for the surgical therapy of adrenal tumors referring to patients of all age groups in operative medicine who require adrenal surgery. It primarily addresses general and visceral surgeons but offers information for all medical doctors related to conservative, ambulatory or inpatient care, rehabilitation, and general practice as well as pediatrics. It extends to interested patients to improve the knowledge and participation in the decision-making process regarding indications and methods of management of adrenal tumors. Furthermore, it provides effective medical options for the surgical treatment of adrenal lesions and balances positive and negative effects. Specific clinical questions addressed refer to indication, diagnostic procedures, effective therapeutic alternatives to surgery, type and extent of surgery, and postoperative management and follow-up regime. METHODS: A PubMed research using specific key words identified literature to be considered and was evaluated for evidence previous to a formal Delphi decision process that finalized consented recommendations in a multidisciplinary setting. RESULTS: Overall, 12 general and 52 specific recommendations regarding surgery for adrenal tumors were generated and complementary comments provided. CONCLUSION: Effective and balanced medical options for the surgical treatment of adrenal tumors are provided on evidence-base. Specific clinical questions regarding indication, diagnostic procedures, alternatives to and type as well as extent of surgery for adrenal tumors including postoperative management are addressed.

Radiation exposure of adrenal vein sampling: a German Multicenter Study

Objective: Adrenal vein sampling (AVS) represents the current diagnostic standard for subtype differentiation in primary aldosteronism (PA). However, AVS has its drawbacks. It is invasive, expensive, requires an experienced interventional radiologist and comes with radiation exposure. However, exact radiation exposure of patients undergoing AVS has never been examined. Design and Methods: We retrospectively analyzed radiation exposure of 656 AVS performed between 1999 and 2017 at four university hospitals. The primary outcomes were dose area product (DAP) and fluoroscopy time (FT). Consecutively the effective dose (ED) was approximately calculated. Results: Median DAP was found to be 32.5 Gy*cm2 (0.3­3181) and FT 18 min (0.3­184). The calculated ED was 6.4 mSv (0.1­636). Remarkably, values between participating centers highly varied: Median DAP ranged from 16 to 147 Gy*cm2, FT from 16 to 27 min, and ED from 3.2 to 29 mSv. As main reason for this variation, differences regarding AVS protocols between centers could be identified, such as number of sampling locations, frames per second and the use of digital subtraction angiographies. Conclusions: This first systematic assessment of radiation exposure in AVS not only shows fairly high values for patients, but also states notable differences among the centers. Thus, we not only recommend taking into account the risk of radiation exposure, when referring patients to undergo AVS, but also to establish improved standard operating procedures to prevent unnecessary radiation exposure.

[Surgical strategies for non-metastatic adrenocortical carcinoma]. / Chirurgische Strategien beim nichtmetastasierten Nebennierenrindenkarzinom.

Adrenocortical carcinomas (ACC) are rare but highly aggressive tumors. It is very difficult to differentiate small locally limited ACCs from benign adenomas. A spontaneous density >10 Hounsfield units in non-enhanced CT scan and a slow washout after contrast injection are suspicious of malignancy but with a low specificity. Preoperatively, a hormonal work-up is mandatory for all adrenal tumors. Each patient should be discussed in an interdisciplinary board. For non-metastatic ACCs (ENSAT stages I-III) radical resection is the treatment of choice. R0-resection and avoiding violation of the tumor capsule are the most important prognostic factors for long-term survival. Although discrepant reports regarding the benefits of lymphadenectomy have been published, lymph node dissection at least in the periadrenal area and in the renal hilum (optional extension to paraaortal and paracaval nodes) should be performed in the case of lymph node involvement. The role of prophylactic lymphadenectomy needs to be analyzed in further studies. The gold standard remains the open approach but minimally invasive procedures are also an option, especially in stage I-II tumors, if the principles of oncological surgery are respected. In this case, long-term survival rates are comparable. As local recurrence rates are lower and time to local recurrence is longer in patients who are operated on at a dedicated center (>10 adrenalectomies/year), adrenalectomy for ACC should be performed by an experienced surgeon.

[Clinical nutrition in surgery. Guidelines of the German Society for Nutritional Medicine]. / Klinische Ernährung in der Chirurgie. S3-Leitlinie der Deutschen Gesellschaft für Ernährungsmedizin e. V.

BACKGROUND: While enhanced recovery after surgery (ERAS) programs are the standard for perioperative management, special nutritional care has to be administered to malnourished patients and those at metabolic risk with special regard to patients with postoperative complications. METHODS: Existing guidelines of the German and European societies of nutritional medicine (DGEM and ESPEN) on enteral and parenteral nutrition in surgery were merged and in accordance with the principles of the Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF, German Association of the Scientific Medical Societies) and Ärztliches Zentrum für Qualität in der Medizin (AeZQ, German Agency for Quality in Medicine) revised and extended. RESULTS AND DISCUSSION: The working group developed 41 consensus-based recommendations for perioperative nutrition. The recommendation strength is: 9x A (recommendation based on significant good quality literature containing at least one randomized controlled trial), 12x B (recommendation based on well-designed trial without randomization), 13x C (recommendation based on expert opinions and/or clinical experience of respected authorities) and 7x CCP (clinical consensus point). CONCLUSION: Even in patients without obvious malnutrition perioperative nutritional support is indicated when oral food intake is not feasible or inadequate for a longer period of time.

Effect of pre- and probiotics on liver regeneration after resection: a randomised, double-blind pilot study.

Liver regeneration is a prerequisite for extended liver surgery. Several studies have shown that the bacterial gut flora is able to modulate liver function. Previously we observed that synbiotics could partly reverse the impaired mitosis rate of hepatocytes in a rat model of synchronous liver resection and colon anastomosis. The effect of synbiotics on liver function after hepatic resection has not been analysed yet. A prospective randomised double-blind pilot trial was undertaken in 19 patients scheduled for right hepatectomy. All patients received enteral nutrition immediately post-operatively. Comparison was made between a group receiving a combination of four probiotics and four fibres and a placebo group receiving the fibres only starting the day before surgery and continuing for 10 days. Primary study endpoint was the liver function capacity measured by 13C-methacetin breath test and indocyanine green plasma disappearance rate. Portal vein flow, liver volumetry, laboratory parameters for liver function, length of hospital stay, post-operative complications and side effects of synbiotic therapy were recorded. Liver function capacity was comparable in both groups. Complications had a negative impact on liver function. Because complications were more severe in the verum group, a sub-analysis was performed. In case of an uncomplicated course, liver function capacity was better in the patients with synbiotics. No severe side effects occurred. Synbiotics might be able to increase liver function capacity in patients after liver resection, but patient numbers were too small and the clinical courses too heterogeneous to draw any definite conclusions.

Impact of image fusion and attenuation correction by SPECT-CT on the scintigraphic detection of parathyroid adenomas.

AIM: In addition to planar parathyroid scintigraphy, SPECT and image fusion with CT/MR improve adenoma detection in primary hyperparathyroidism (pHPT). This study evaluated the use of a hybrid SPECT-CT device concerning image fusion and attenuation correction (AC). PATIENTS, METHODS: The data of 26 patients with pHPT, preoperatively examined by (99m)Tc-sestamibi dual-phase scintigraphy plus SPECT-CT (low-dose CT), was retrospectively evaluated by two observers in a consensus reading. The images of planar scintigraphy, non-attenuation corrected SPECT (SPECT(NAC)), attenuation corrected SPECT (SPECT(AC)) and SPECT(AC)-CT were interpreted and compared to the results of surgery. The effect of AC on focus intensity was semiquantified by determination of the tumor-to-background (TB) ratio for SPECT(AC) and SPECT(NAC). Finally, the TB(AC)/TB(NAC)-ratio was calculated for each focus and correlated to the distance of a focus from the body surface. RESULTS: 20/26 (77%) patients were positive in planar scintigraphy. One focus was detected by SPECT only. AC of SPECT-data increased image contrast but had no impact on the detection rate. Additional SPECT(AC)-CT image fusion facilitated the localization of three mediastinal foci. In the semiquantitative analysis an increase in TB after AC was observed, although there was no strong correlation between depth of the focus (16-60 mm) and the TB(AC)/TB(NAC)-ratio (r = 0.213, p = 0.353). CONCLUSION: The detection rate of planar scintigraphy is only slightly improved by SPECT imaging. Due to the low spatial resolution of the CT component, the benefit of image fusion is limited to mediastinal foci. However, as TB and image contrast is measurably improved after AC there is a potential to improve the sensitivity of parathyroid SPECT.

[Influence of probiotics and fibre on the incidence of bacterial infections following major abdominal surgery - results of a prospective trial]. / Einfluss von Probiotika und Ballaststoffen auf die Inzidenz bakterieller Infektionen nach viszeralchirurgischen Eingriffen - Ergebnisse einer prospektiven Studie.

INTRODUCTION: Early enteral nutrition with fibre and probiotics has been effective in preventing bacterial translocation and is therefore expected to reduce the incidence of postoperative bacterial infections. PATIENTS AND METHODS: In a prospective randomized trial including 172 patients following major abdominal surgery or liver transplantation, the incidence of bacterial infections was compared in patients receiving either a) conventional parenteral or enteral nutrition, b) enteral nutrition with fibre and lactobacillus plantarum 299 or c) enteral nutrition with fibre and heat inactivated lactobacilli (placebo). Liver transplant recipients were also treated with selective bowel decontamination (SBD). Routine laboratory parameters, nutritional parameters and the cellular immune status were measured preoperatively and on postoperative days 1, 5 and 10. RESULTS: Patients were comparable regarding preoperative ASA-classification, Child-Pugh classification of cirrhosis, operative data and immunosuppression. The incidence of bacterial infections after liver, gastric oder pancreas resection was 31 % in the conventional group a) compared to 4 % in the lactobacillus-group b) and 13 % in the placebo-group c). In the analysis of 95 liver transplant recipients, 13 % group b)-patients developed infections compared to 48 % group a)-patients and 34 % group c)-patients. The difference between groups a) and b) was statistically significant in both cases. In addition, the duration of antibiotic therapy was significantly shorter in the lactobacillus-group. Cholangitis and pneumonia were the most frequent infections and enterococci the most frequently isolated bacteria. Fibre and lactobacilli were well tolerated in most cases. CONCLUSION: Fibre and probiotics could lower the incidence of bacterial infections following major abdominal surgery in comparison to conventional nutrition with or without SBD. With this new concept, costs can be reduced by shortening the duration of antibiotic therapy and sparing SBD.

Intraoperative measurement of intact parathyroid hormone in renal hyperparathyroidism by an inexpensive routine assay.

Although the kinetics of intraoperative intact parathyroid hormone (iPTH) are well characterised in primary hyperparathyroidism, no data are available for patients with renal hyperparathyroidism and renal insufficiency, partially because of the high costs of intraoperative quick iPTH measurement. Therefore we evaluated an inexpensive laboratory test with a duration of 18 min for intraoperative use and measured iPTH intraoperatively in 34 patients with renal hyperparathyroidism. Samples were taken before and 5 min and 15 min after parathyroid resection. Blood samples were put on ice immediately and sent to the hospital central laboratory via a pneumatic tube system. The first 76 probes were measured in parallel using three assays: the Nichols Quick PTH, the Roche Elecsys and the Biermann Immulite assay. The subsequent samples were only measured using the Elecsys assay. Determination of iPTH from 76 samples showed a correlation coefficient of 0.997 between the Immulite and Elecsys assay and a correlation coefficient of 0.987 for the Nichols Quick PTH and the Elecsys test. In renal hyperparathyroidism the mean iPTH was 26+/-2% of the starting value 5 min after subtotal parathyroidectomy and 18+/-2% after 15 min. Renal function influenced absolute iPTH values in patients with renal hyperparathyroidism but not relative changes. In patients with terminal renal insufficiency iPTH decreased from 615+/-57 pg/m before preparation to 109+/-13 pg/ml 15 min after subtotal resection. In contrast in patients after kidney transplantation iPTH decreased from a lower starting value of 341+/-94 pg/ml to 58+/-9 pg/ml after 15 min. The iPTH kinetics showed a biphasic clearance of iPTH with an initial dominant half-life of 3.2 min and a terminal half-life of 29.2 min. Half-life did not correlate with renal function. All operations were successful as indicated by an adequate drop in PTH (from 709+/-92 pg/ml preoperatively to 22+/-6 pg/ml at discharge) and calcium (from 2.57+/-0.04 mmol/l to 2.32+/-0.04 mmol/l). In conclusion, intraoperative measurement of iPTH is also reliable in patients with renal hyperparathyroidism. Elimination kinetics are similar to that in patients with primary disease. However, the half-life was not influenced by renal function. The availability of a quick, inexpensive, routine iPTH test might expand its use to renal hyperparathyroidism, specifically for surgical decisions in problem cases.

Occurrence and clinical outcome of lamivudine-resistant hepatitis B infection after liver transplantation.

Lamivudine treatment of hepatitis B after orthotopic liver transplantation (OLT) is often accompanied by fast viral-resistance formation. Although no clinical data are available, in vitro data indicate that lamivudine-resistant reinfection has a mild course because of defective viral replication. Between 1996 and 1999, a total of 34 patients were treated with lamivudine because of hepatitis B recurrence after OLT. All patients developed reinfection despite long-term passive immunoprophylaxis with hepatitis B immunoglobulin, diagnosed by positive hepatitis B surface antigen and positive hepatitis B virus (HBV) DNA. Before treatment with lamivudine, 21 of these patients underwent a course of famciclovir and developed resistance. Monthly laboratory tests and sequential liver biopsies were performed during the follow-up period. Nineteen of 34 patients (56%) developed lamivudine resistance during the follow-up period of 12 to 49 months. One- and 3-year graft survival rates after the diagnosis of lamivudine resistance were 89% and 66%, respectively. In most cases, lamivudine resistance was associated with high viral replication (3,012 +/- 574 pg/mL 1 month after the diagnosis of lamivudine resistance); however, liver enzyme levels were only moderately elevated (alanine aminotransferase [ALT], 45 +/- 16 U/L). Only 3 patients (15%) showed a rapid increase in ALT level to more than 500 U/L within 3 months after resistance developed. All other patients had mildly elevated liver enzyme levels during the first 6 to 8 months after lamivudine resistance. In the later course, liver enzyme levels increased in most patients. Fourteen patients with elevated transaminase levels were switched to lamivudine plus interferon alfa (n = 8) or lamivudine plus famciclovir therapy (n = 6). This combination was successful in most cases, decreasing HBV DNA and liver enzyme levels. Four patients with lamivudine resistance died during follow-up, only 1 patient because of HBV reinfection. In addition, 2 patients underwent retransplantation because of hepatitis B cirrhosis of the first graft. Compared with historic courses of wild-type recurrence, lamivudine-resistant reinfection is characterized by a milder clinical course. Fulminant cases were not observed; however, in three cases, chronic liver failure developed. The combination of different antivirals diminished viral replication after lamivudine resistance. In the future, new antiviral agents, such as adefovir, might further expand therapeutic options.

Prospective randomized trial to assess the value of preemptive oral therapy for CMV infection following liver transplantation.

BACKGROUND: With the development of sensitive tests to detect cytomegalovirus (CMV) viremia, preemptive approaches become a reasonable alternative to general CMV prophylaxis. We performed a randomized trial comparing pp65-antigenemia guided preemptive therapy using oral ganciclovir with symptom-triggered intravenous ganciclovir treatment. METHODS: Eighty-eight of 372 liver transplant recipients developed antigenemia early after orthotopic liver transplantation. Twenty-eight symptomatic patients with antigenemia were excluded from randomization and treated with intravenous ganciclovir. Sixty pp65-antigen-positive asymptomatic patients were randomized to receive either oral ganciclovir 3x1 g/day for 14 days (group 1) or no preemptive treatment (group 2). Patients that developed CMV disease were treated with intravenous ganciclovir 2x5 mg/kg body weight for 14 days. The high-risk (Donor+/Recipient-) patients were equally distributed in the two study groups. RESULTS: Three of 30 (10%) patients on oral ganciclovir developed mild to moderate CMV disease compared with 6/30 (20%) patients in the control group. In the Donor+/Recipient- patients, the incidence of CMV disease was 1/6 and 3/7. All disease episodes resolved after intravenous treatment. The 1- and 3-year patient and organ survival was the same in the study groups and in the patients with or without CMV infection. No deaths related to CMV occurred. CONCLUSIONS: The positive predictive value of pp65-antigenemia for the development of CMV disease was very low, and, in 28/88 patients (32%), antigenemia did not precede symptoms. Therefore, pp65-antigenemia is of limited value in deciding on the timing and need for ganciclovir therapy after liver transplantation.

[Surgical procedures and risk factors in therapy of benign multinodular goiter. A statistical comparison of the incidence of complications]. / Operationsverfahren und Risikofaktoren in der Therapie der benignen Struma multinodosa. Ein statistischer Vergleich der Komplikationshäufigkeit.

BACKGROUND: The best surgical approach for bilateral resections in the therapy of benign multinodular goiter is still controversial. METHODS: The purpose of this study was to compare different modes of resection concerning differences in complication rates and risk factors influencing the outcome. 2235 thyroid resections for multinodular goiter between 1985 and 1999 were analysed. RESULTS: When compared to bilateral subtotal resection (n = 327; 14.6%), those patients who received lobectomy and contralateral subtotal resection (n = 952; 42.6%) showed a statistically significant higher incidence of temporary hypocalcaemia (22.6% versus 15.9%) only. The "nerve at risk"-analysis demonstrated no significant difference of laryngeal nerve paralysis between the side of lobectomy and subtotal resection, respectively. In comparison to the entire patient population operations for recurrent goiters had an equal operative risk, whereas patients with goiter WHO III or an intrathoracic location had significant higher rates of temporary laryngeal nerve paralysis and hypocalcaemia. CONCLUSIONS: Lobectomy and contralateral subtotal resection offers numerous advantages concerning intraoperative variability and definitive resection of suspicious nodules. With an adequate standardized surgical technique and identification of the laryngeal nerve, the complication rate is comparable to bilateral subtotal resection.

Lamivudine as first- and second-line treatment of hepatitis B infection after liver transplantation.

Lamivudine and famciclovir have expanded therapeutical options for HBV infection after liver transplantation. First studies confirm good antiviral effects of both, but at present the major problem seems to be a rapid resistance formation in immunosuppressed patients. Thirty-four adult patients with HBV recurrence despite passive immunoprophylaxis and seven with de novo infection after orthotopic liver transplantation (OLT) were treated with 100-150 mg lamivudine daily. Patients were either treated directly after infection (n = 14) or after breakthrough of viral replication during an initial famciclovir therapy (n = 27). All patients except two responded to treatment with a reduction of serum HBV-DNA of over 50%. Thirty-one patients (76%) turned HBV-DNA-negative during lamivudine therapy. Viral breakthrough was observed in 14 of these patients after 4-13 months of treatment. A total of 17 patients (40%) remained HBV-DNA-negative for more than 12 months. Only nine patients eliminated HBsAg, of which four had and an HDV coinfection. None of the HBeAg-positive patients converted to anti-HBe. Most patients showed a prompt and significant reduction of aspartate aminotransferase (ALAT) levels. No severe complications occurred. Therefore, a safe and effective therapy of HBV infection after transplantation is possible with lamivudine. Viral replication is suppressed even in patients who revealed breakthrough during famciclovir therapy. Resistance formation as a major drawback occurred in one third of the patients within the first year of treatment.

Quadruple tacrolimus-based induction therapy including azathioprine and ALG does not significantly improve outcome after liver transplantation when compared with standard induction with tacrolimus and steroids: results of a prospective, randomized trial.

BACKGROUND: Tacrolimus in combination with prednisolone has been proven to be a safe and effective immunosuppressive induction therapy in solid organ transplantation. However, it remains unclear whether a tacrolimus-based quadruple induction regimen with azathioprine and an antilymphocytic preparation could further improve the results after orthotopic liver transplantation. Therefore, we designed a prospective, randomized study to compare the immunosuppressive efficacy of dual (tacrolimus and prednisolone) and quadruple (tacrolimus, azathioprine, ALG Merieux and prednisolone) induction after liver transplantation. METHODS: After randomization, 120 consecutive patients of primary liver transplants were divided into the dual group (n=59) and the quadruple group (n=61) and followed for a minimum of 3 years. RESULTS: Patient survival at 3 years was 88.2% in the dual versus 94.9% in the quadruple group. Overall 25 patients in each group (41 and 42%, respectively) developed acute rejection. There was no difference in the number and severity of rejections. In each group only four patients required OKT3-therapy, however, although three of four patients in the quadruple group responded to OKT3 and cleared rejection, none of the four patients in the dual group were treated successfully with OKT3 (P<0.02). Rejection in these patients resolved only after additional treatment with mycophenolate mofetil. Adverse events and infections were equally distributed in both groups. Asymptomatic Cytomegalovirus infections were more common in the quadruple group (P<0.02). As of today, only one patient developed posttransplant lymphoproliferative disease (dual group). CONCLUSIONS: The data from our single-center study indicate that both tacrolimus-based dual and quadruple immunosuppressive induction regimens yield similar safety and effectiveness after liver transplantation.