Comparison of laparoscopic and open tension-free repair of recurrent inguinal hernias: a prospective randomized study.

BACKGROUND: The current prospective randomized controlled clinical study aimed to assess the short- and long-term results of recurrent inguinal hernia repair, and to compare the results for transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) procedures with those for open tension-free repair. METHODS: For this study, 82 patients were randomly assigned to undergo TAPP (group A, n = 24), TEP (group B, n = 26), or open Lichtenstein hernioplasty (group C, n = 32). All the patients with recurrent inguinal hernias had undergone previous repair using conventional open procedures. Physical examination showed Nyhus type II hernia in the vast majority of the patients (59%). High-risk patients (American Society of Anesthesiology [ASA] III or IV); coagulation disorders; previous abdominal or pelvic surgery; and irreducible, congenital, and massive scrotal or sliding hernias were excluded from the study. RESULTS: There was a statistically significant difference (p = 0.001) in operating time favoring the open procedure. The intensity of postoperative pain was greater in the open hernia repair group 24 h, 48 h, and 7 days after surgery (p = 0.001), with a greater consumption of pain medication among these patients (p < 0.004). The median time until return to work was 14 days for group A, 13 days for Group g, and 20 days for group C. The comparison was in favor of laparoscopically treated patients. Nine recurrences (4 in the laparoscopic groups and 5 in the open group) were documented within 3 years of follow-up evaluation. CONCLUSION: Laparoscopic inguinal hernia repair (TAPP or TEP) is the method of choice for dealing with recurrent inguinal hernia.

Changing trends in the management of Klatskin tumor.

BACKGROUND/AIMS: To evaluate the long-term outcome of a multidisciplinary approach for advanced Klatskin tumor involving the hepatic hilus. METHODOLOGY: A retrospective analysis was undertaken in 110 patients between 1993 and 2003. The patients were divided into Group A (n=42) and Group B (n=58). Group A patients underwent local excision of the tumor and Group B patients underwent combined tumor and liver resection with or without resection of the regional vascular structures. On admission, all patients underwent percutaneous transhepatic biliary drainage. Where hepatectomy was planned, portal vein branch ligation and transection was done ipsilateral to the liver lobe where the tumor was present. An arterial catheter was introduced into the hepatic artery at the end of the surgery, for adjuvant locoregional immunochemotherapy, which was carried out in all patients. The second-stage resectional surgery was carried out 35 days later. RESULTS: The overall mean survival for Group A patients was 29 months (range 14 to 76). The mean disease-free survival was 28 months (range 10-52). Five-year survival rate was 5% and five-year disease-free survival was 0%. The overall mean survival for Group B patients was 39 months (range 28 to 79). The mean disease-free survival was 32 months (range 17-72). Five-year survival rate was 20% and five-year disease-free survival was 10%. CONCLUSIONS: The concept of a multidisciplinary approach has significantly improved survival in patients with a grave disease like Klatskin tumor.

Two-stage liver surgery for advanced liver metastasis synchronous with colorectal tumor.

BACKGROUND/AIMS: To evaluate the efficacy of two-stage surgery and multidisciplinary approach, in the treatment of primary colorectal cancer, synchronous with advanced liver metastases. METHODOLOGY: Sixty-two patients who underwent two-stage surgery for advanced metastatic liver disease synchronous with colorectal tumor were studied. In the first-stage surgery, the primary colorectal tumor was resected. Depending on the location of the main tumor mass, ligation and transection of the relevant (right or left) main portal vein branch was done. Subsequently, the metastatic nodules in the contralateral lobe were ablated by microwave therapy. An arterial jet port catheter was also introduced into the hepatic artery via the gastroduodenal artery for locoregional chemoimmunotherapy. Two days after the first-stage surgery locoregional transarterial targeting chemoimmunotherapy was given. The second-stage hemihepatectomy was carried out forty to forty-five days after the initial surgery. As an adjuvant treatment locoregional targeting chemoimmunotherapy was carried out in all patients via the arterial chemoport. RESULTS: Mean survival was 66+/-4 months. There were no operative deaths. CONCLUSIONS: Two-stage liver surgery including, portal vein branch ligation, microwave ablative therapy and transarterial targeting locoregional chemoimmunotherapy is the best treatment for advanced, synchronous metastatic liver disease of colorectal origin. It results in an increase in the overall survival of these patients with good postoperative quality of life, which encourages the hepato-biliary surgeon to venture upon this herculean task thus increasing the resectability rate of the tumor.

Mono-bloc total spleno-pancreaticoduodenectomy for pancreatic head carcinoma with portal-mesenteric venous invasion. A prospective randomized study.

BACKGROUND/AIMS: To evaluate, the early and long-term results of mono-bloc spleno-pancreatic and vascular resection for advanced carcinoma of the head of the pancreas, with portal-mesenteric venous invasion. METHODOLOGY: In a prospective, randomized trial, fifty-six patients with advanced carcinoma of the head of the pancreas with vascular invasion were studied. Patients were randomly divided in two groups A and B. Group A patients underwent an en-bloc spleno-pancreatic and vascular resection. Group B patients underwent a palliative gastro-biliary bypass. Patients in both groups were subjected to adjuvant locoregional chemoimmunotherapy, through an arterial catheter introduced into the superior mesenteric artery via a jejunal arterial branch. RESULTS: The 2- and 5-year survival rates for Group A patients were 81.8% and 18.5%. The respective percentages for disease-free survival were 60.6% and 0%. Two-year survival for group B was nil. CONCLUSIONS: Mono-bloc spleno-pancreaticoduodenectomy and regional vascular resection and reconstruction, with adjuvant locoregional chemoimmunotherapy leads to substantial prolongation of survival and optimization of quality of life.

New frontiers in the management of advanced hepatocellular carcinoma. "A new look to an old problem".

BACKGROUND/AIMS: To evaluate the benefits of two-stage liver surgery with main portal branch ligation and transection combined with transarterial targeting locoregional neo and adjuvant immunochemotherapy in patients suffering from hepatocellular carcinoma. METHODOLOGY: 43 consecutive patients underwent two-stage liver surgery for advanced hepatocellular carcinoma. First we performed ligation and transection of the main portal vein branch corresponding to the liver lobe occupied by the tumor. Subsequently we introduced an arterial jet port catheter towards the hepatic artery via the gastroduodenal artery. After locoregional transarterial targeting immunochemotherapy regimen the patient underwent a second laparotomy for hemihepatectomy. Following surgery, locoregional transarterial targeting immunochemotherapy was given to all patients via the arterial port of the gastroduodenal artery as an adjuvant treatment. RESULTS: Mean survival was 41 months. There were no operative deaths. CONCLUSIONS: Two-stage liver surgery and transarterial targeting locoregional immunochemotherapy is the favorable option of treatment for advanced hepatocellular carcinoma. It not only results in an increase in the overall survival of these patients, but also increases the rate of resectability of these tumors by the hepatobiliary surgeon.

Regional chemoimmunotherapy for nonresectable metastatic liver disease of colorectal origin. A prospective randomized study.

BACKGROUND/AIMS: The study has been designed to assess the potential advantages of regional targeting chemoimmunotherapy versus systemic chemotherapy and immunotherapy in a number of patients suffering from nonresectable metastatic liver disease of colorectal origin. METHODOLOGY: From January 1996 to January 2001 (86) patients with unresectable metastatic liver disease of colorectal origin were randomly assigned to two groups. Group A (n = 44 patients), who received regional targeting chemoimmunotherapy through an arterial catheter introduced subcutaneously under echo guidance into the hepatic artery. Group B (n = 42 patients) received systemic chemoimmunotherapy. RESULTS: Survival of Group A patients ranged from 9 to 48 months (mean: 33 months), while Group B patients' survival ranged from 8 to 18 months (mean: 10 months). Response to treatment was 75% for Group A patients versus 52% for Group B. There were statistically significant differences in survival between the two groups (P = 0.0001). CONCLUSIONS: We believe that the data of this study reconfirms previously reported experience about the advantages of regional chemoimmunotherapy when compared with systemic chemoimmunotherapy for the management of advanced metastatic liver disease.

Laparoscopic drainage of infected hydatid liver cysts.

From October 1997 until March 1999, we performed this procedure in three patients suffering from suppurated echinococcal liver cyst. Trocar sites are approximately the same to those already known for laparoscopic cholecystectomy. A thoracostomy tube is inserted through the abdominal wall and under direct vision is forced to the projecting part of the cyst for the aspiration of the gross content. The adventitia and thinned out liver are cut with electrocautery and scissors. A large bore fenestrated drainage tube is inserted within the cavity of the cyst and fixed in place. We did not have wound infection in any of the three patients. The average hospital stay was 19 days. No signs of recurrence or any other source of morbidity were apparent within the 18, 14 and 6 months of follow up of the three patients respectively.

Long-term results following resectional surgery for Klatskin tumors. A twenty-year personal experience.

BACKGROUND/AIMS: The purpose of this study was to assess whether long-term survival in patients suffering from cholangiocarcinomas of the porta hepatis is significantly different when comparing results between local and extended procedures in order to justify increased mortality and morbidity following extensive resections. METHODOLOGY: From November 1991 to May 2000, 46 patients with Klatskin tumor were assigned to two groups. Group A patients (n = 25) had local resection and group B patients (n = 21) had local resection plus hemihepatectomy. On admission, all patients were drained via percutaneous transhepatic biliary drainage. In all patients we proceeded with an internal biliary drainage in order to anticipate jaundice and decompensated liver function. Internal biliary drainage was carried out 35-40 days before surgery. At the end of the operation an arterial catheter was introduced into the common hepatic artery for adjuvant locoregional targeting immunochemotherapy, which was initiated 20 days following surgery in all patients. RESULTS: Overall survival for group A patients ranged from 14 months to 76 months (mean: 29). Disease-free survival ranged from 10-52 months (mean: 25). Five-year survival rate was 10%. Five-year disease-free survival was 0%. Overall survival for group B patients ranged from 28 months to 79 months (mean: 39). Disease-free survival ranged from 17-72 months (mean: 32). Five-year survival rate was 20%. Five-year disease-free survival rate was 10%. CONCLUSIONS: Combined tumor and liver resection is associated with significantly better results when compared with those following tumor resection alone.

Preoperative main portal branch transection combined with liver locoregional transarterial neo and adjuvant immunochemotherapy for patients with hepatocellular carcinoma.

BACKGROUND/AIMS: Main portal branch embolization was developed several years before in an attempt to improve prognosis and outcome for patients suffering from advanced liver malignancies. METHODOLOGY: From September 1993 to September 2000 43 patients with advanced hepatocellular carcinoma underwent main portal branch transection and neo- and adjuvant transarterial immunochemotherapy. Forty days after initial surgery, all patients underwent a phase II surgical exploration for liver resection. RESULTS: Survival ranged from 18 months to 64 months with a median of 41 months. Two- and 5-year survival was 75% and 57%, respectively. CONCLUSIONS: Main portal branch transection combined with major liver resection and neoadjuvant and adjuvant locoregional immunochemotherapy fulfilled our expectations firstly for increasing the resectability rate and secondly for increasing the overall survival and the disease-free survival.

Metastatic melanoma: transplenic immunostimulation--a new therapeutical alternative for an ever-challenging disease.

BACKGROUND/AIMS: The successful management of metastatic melanoma is mostly relevant to the feasibility of a sustained immunostimulation requiring high doses of interleukin-2 (IL-2). Sustained immune response is initiated, in terms of cellular and humoral immunity, persisting for 15 days following the end of exogenous IL-2 transplenic administration. METHODOLOGY: We proceed to the transplenic immunostimulation using IL-2 suspended in lipiodolurografin emulsion through an arterial catheter, which is introduced into the splenic artery through laparotomy for the management of patients with advanced metastatic melanoma. Eligible for our study were 19 patients undergoing transplenic immunostimulation and locoregional or systemic chemotherapy, in relation to the site of the disease. In cases of metastatic liver melanoma, transtumoral immunostimulation was also carried out. RESULTS: Complete response to the regimen, partial response, stable disease and progressive disease were observed in 21%, 42%, 16%, and 21%, respectively. CONCLUSIONS: Transplenic immunostimulation has promising potentials in metastatic melanoma patients, on the basis of present results.

Resectional liver surgery in metastatic liver disease.

BACKGROUND/AIMS: To increase resectability rate and decrease intra-hepatic recurrence of metastatic liver disease of patients suffering from secondary liver tumors. Metastatic liver disease remains challenging and life threatening. At the time of diagnosis only 10% of patients are amenable to liver resection and of those 60-70% will develop recurrence in the residual liver 16 to 24 months following liver resection METHODOLOGY: Seventy patients out of a total number of 305 seen between November 1991 and May 1998, underwent combined liver resection followed by adjuvant locoregional targeted immunochemotherapy. Patients were divided in two groups. Group A (n=32) had uni-lobular localization of their disease and group B (n=38) had bi-lobular spread of the disease, but tumor occupied was less than 70% of liver surface. All had hepatic resection followed by adjuvant immuno-chemotherapy. RESULTS: Group A (n=32) had a 5 year survival of 75% with 8 patients alive more than 6 years and a mean survival for alive and dead patients of 50 months. Group B (n=38) had a mean survival of 40 months with 6 patients alive longer than 5 years. CONCLUSIONS: Liver resection combined with adjuvant immuno-chemotherapy enhances overall long-term survival in both patients with limited and advanced metastatic liver disease, and is recommended as a promising therapeutical alternative.

Intrasplenic immunostimulation in malignancies fact or fiction? Present and future.

BACKGROUND/AIMS: The clinical application of intrasplenic immunostimulation with IL-2 in a group of patients suffering from metastatic renal carcinoma, melanoma, recurrent rectal carcinoma, lung carcinoma and gastric carcinoma are discussed in terms of clinical applicability, effectiveness and survival. METHODOLOGY: From May 1996 to February 1998, 45 patients with advanced malignancies were admitted to Athens Medical Center for intrasplenic immunostimulation. Transplenic immunostimulation was carried out via a subcutaneously implanted port. The injected therapy included IL-2 (Proleukin) 1 ml 18 x 10(6) suspended in 1.5 ml of lipiodol and 0.5 ml of urografin. In conjunction gamma-INF (Immukin) 0.5 ml 100 mcg, was administered. RESULTS: Patients included in this study have completed their treatment, or are still undergoing maintenance treatment. The duration of the CR was between 11 and 16 months, and for PR was between 10-14 months. For melanoma patients (n = 9), 3 patients with PD died 9, 10 and 12 months after initial treatment began. The remaining patients (n = 6) are alive with a mean survival rate of 16 months. Of those patients, 4 have been classified as complete responders, being completely free of disease at this time. The number of CR for patients with lung, renal and recurrent rectal cancer was achieved as a result of the continuing maintenance treatment. Twenty-two patients remain alive and 23 patients have died. From those alive (n = 22), 10 patients are complete responders and free of disease, 10 are partial responders with controlled disease and 2 remain with standard disease. For those surviving patients with lung cancer, the mean survival time is 14 months. Patients with recurrent rectal cancer and renal cancer were shown to have a mean survival time of 15 and 13 months, respectively. CONCLUSION: The safety, effectiveness and feasibility of long-lasting administration of high dosages of IL-2 are documented from the data of this study. Intrasplenic immunostimulation utilizing lipiodol-urografin emulsion as a carrier, offers new possibilities for the safe administration of long lasting high dosages of IL-2 and gamma-INF. Further studies are warranted, to further elucidate the results of this phenomenon.

Pancreatic resection for pancreatic carcinoma combined with neo- and adjuvant locoregional targeting immuno-chemotherapy--a prospective randomized study.

BACKGROUND/AIMS: The effects on early and late results of combined pancreatic resection with neo- and adjuvant immuno-chemotherapy for patients undergoing pancreatic resection are prospectively evaluated. METHODOLOGY: A group of 26 patients was divided into two groups, which were matched in terms of age-sex ratio, stage of disease, histological diagnosis and mode of pancreatic resection. Group A patients received a multimodality therapy, combining pancreatic resection with neo- and adjuvant locoregional targeting immunochemotherapy. Group B received pancreatic surgery only. RESULTS: For Group A patients (n = 14pts), a complete response was seen in 11 patients with a time interval ranging from 9 to 29 months. In the remaining 3 patients liver secondaries developed 12 months after pancreatic resection in 2 patients and the other patient developed pulmonary metastases 22 months after pancreatic resection. All patients (n = 3pts) are alive, but continue to have the disease. For Group B patients (n = 12pts), a complete response was seen in 3 patients with a survival of 9, 10 and 20 months following pancreatic resection. Six patients died due to locoregional recurrence of the disease, with the survival rate ranging from 7 to 18 months (mean 10 months). Locoregional recurrence was complicated with liver secondaries (n = 3) and with peritoneal dissemination of the disease in a further 3 patients. The remaining 3 patients are alive, but continue to have the disease due to locoregional recurrence. CONCLUSIONS: Patients in whom neo- and adjuvant locoregional immunochemotherapy was carried out in conjunction with pancreatic resection, demonstrated a significantly higher response rate to treatment. Therefore the data collected offers clear evidence, regarding the usefulness, applicability and safety of combined neo- and adjuvant therapy with pancreatic resection. A Multi-modality approach is therefore highly recommended.

Targeting locoregional immunochemotherapy with new drugs in metastatic liver disease: a promising alternative.

BACKGROUND/AIMS: A retrospective report of our experience with adjuvant targeted locoregional immunochemotherapy using new drugs in 29 Stage IV colorectal cancer patients with unresectable metastatic liver disease from September 1997 to December 1998. METHODOLOGY: After pre-operative screening, all patients were subjected to laparotomy for insertion of transhepatic and transplenic arterial catheters, both implanted subcutaneously in the right upper abdominal quadrant. A bolus transhepatic arterial chemotherapy using Eloxatine 150 mg/m2 and Campton 140 mg/m2, suspended in a 5:1 lipiodol-urografin emulsion, was given 15 days post-operatively, followed the day after by 5 daily transplenic artery and then 5 daily transhepatic arterial injections of IL-2 in a 5:1 lipiodol-urografin mixture. This treatment schema was repeated at 2-month intervals. RESULTS: Treatment response was recorded: CR=24.2%, PR=55.2%, SD=10.3%, and PD=10.3%. Seventy-nine percent responded favorably with 7 patients (24.2%) showing marked tumor bulk reductions. There were no treatment-related morbidities or mortalities. CONCLUSIONS: All 29 patients are alive with a median survival of 11 months as of this writing. Eighty percent report a significant improvement in quality of life. Targeted locoregional immunochemotherapy using the above drugs is a promising option for patients with far-advanced metastatic liver disease.

A prospective randomized study using adjuvant locoregional chemoimmunotherapy in combination with surgery for pancreatic carcinoma.

BACKGROUND/AIMS: A prospective randomized clinical trial combining adjuvant locoregional chemoimmunotherapy for pancreatic carcinoma in 512 patients was conducted from September 1991 to September 1998 at Athens Medical Center. METHODOLOGY: All patients were randomly assigned to (A) Resective Surgery (n=274), and (B) Palliative Surgery (n=238) groups. Each group was further subdivided into: (1) surgery alone, and (2) surgery plus 1-day bolus chemotherapy (Gemcitabine 1 gm/m2, Carboplatin 200 mg/m2 and Mitoxantrone 0.2 g/kg bw suspended in 10 ml of Lipiodol and 2 ml of 58% urografin), and immunotherapy (1 ml IL-2 and 0.5 ml gamma-IFN suspended in 5 ml of Lipiodol and 1 ml of 58% urografin) followed by a 5-day course of transplenic and another 5-day course of transtumoral immunotherapy using the same agents. This was repeated at 2-month intervals during the first post-operative year and every 3 months thereafter. RESULTS: Significant reduction in patient symptomatology and improvements in post-treatment quality of life were noted in patients receiving adjuvant chemoimmunotherapy. Moreover, the mean survival rate significantly improved in patients receiving the adjuvant treatment, both for the resective (32 months) and the palliative (16 months) groups. CONCLUSIONS: The treatment regimen employed was well tolerated and did not contribute to any clinical deterioration. Adjuvant targeted locoregional chemoimmunotherapy is therefore a promising avenue in the management of patients with pancreatic carcinoma.

Resection of unresectable secondary liver tumors--new frontiers in liver surgery.

BACKGROUND/AIM: Despite remarkable advances in diagnostic and therapeutic techniques for metastatic liver disease, this disease remains a challenge for patients and surgeons. In this study we describe our experience in the management of 21 patients referred for treatment due to metastatic disease, between 1992 and 1997, in Athens, Greece. METHODOLOGY: Patients diagnosed with unresectable liver tumors, received a standard treatment, which included neo-adjuvant locoregional immuno-chemotherapy, surgical resection and adjuvant locoregional immuno-chemotherapy. Twenty days after liver resection a standard protocol of combined locoregional immuno-chemotherapy was administered. The protocol included 10 daily courses of transplenic (5-day) and transtumoral (5-day) immunostimulation using proleukine suspended in lipiodol Urografin emulsion. Five days later a standard dose of chemotherapeutical drugs suspended in lipiodol Urografin were given via the catheter of the hepatic artery. The above mode of adjuvant treatment was continued every 2 months for the first postoperative year and every 3 months for the 2nd and 3rd postoperative years, every 4 months for the 4th and 5th postoperative years. At the end of each treatment a blood test, which included the serum values of the tumors markers and an upper abdominal computer tomography was carried out for each patient. The treatment response was evaluated accordingly, and divided into the following categories: complete response, partial response, stable disease and progressive disease. RESULTS: There was no operative mortality. Sequelae and side effects secondary to treatment were minimal In group A and B of this study a 5-year survival rate of 65% and 20% and an overall response rate of 80% and 68% in the above groups was noted, respectively. CONCLUSION: The mode of management offered satisfactory results regarding quality of postoperative life.