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Outline of clinical trials

New cancer-related antigen genetically derived epitopes for treating advanced and recurrent esophageal cancers

  With this research we are aiming to develop new immune therapies for esophageal cancers, and we are verifying the safety and effectiveness of cancer vaccinations using peptides derived from two types of protein, which have been shown specific to esophageal cancer on patients with HLA gene type A*2402, who have advanced esophageal cancers for which there is no other effective treatment. At the same time, we are confirming the extent to which immunity is improved.

( Approved on 18th August 2006 by Wakayama Medical University Ethics Committee: No. 409)

HLA-A* targeting neoplasm newly-formed blood vessels in cases of inoperable, advanced recurrent pancreatic cancer

  With this research, we are we are verifying the safety and effectiveness of cancer vaccine chemotherapy combining  a vaccine treatment using peptides derived from proteins found in newly-formed nutrient vessels within cancers, in patients with HLA gene type A*2402, who have inoperable advanced pancreatic cancer.

( Approved on 18th August 2006 by Wakayama Medical University Ethics Committee: No. 408)

Research into subtotal stomach preservation during pancreatoduodenectomy

  The muscular ring at the exit of the stomach known as the pylorus adjusts the outflow from the stomach. If its nerves are cut during surgery it becomes unable to function fully. For that reason, in order to improve gastric elimination delay after pylorus-preserving pancreatoduodenectomy, we are looking at the significance of the pylorus.

( Approved on 19th August 2005 by Wakayama Medical University Ethics Committee: No. 302)

Clinical research into pancreatic duct tube insertion methods during pancreas-intestine anastomosis

  One of the most difficult complications arising during pancreatic head resection is the occurrence of pancreatic fistula, in which pancreatic fluid leaks from the join between the pancreas and the intestine. Various measures have been tried worldwide in order to reduce pancreatic fistula. We have conventionally used a pancreatic duct tube, and are currently engaged in randomized comparative testing to determine what benefits can be achieved by different methods of insertion.

( Approved on 24th December 2004 by Wakayama Medical University Ethics Committee: No. 301)

Clinical trial of nutritional formula diet (Impact R)- Study of volume to be administered -

  Impact R is a nutritional food product released for use by patients requiring special nutritional management prior to and post-surgery. This nutritional food product has been used for over 10 years in Europe and the USA to supplement the nutrition of patients undergoing surgery, and patients who have suffered serious burns or accidents. It is known to have the effect of reducing the likelihood of infection from pneumonia and other diseases, and shortening the amount of time spent in hospital. Furthermore, ingesting Impact R at a specified frequency suppresses inflammatory reactions, raises the body’s resistance (immunity), and is believed to reduce the likelihood of infection from bacteria etc. It has not yet been clarified in Japan, however, whether Impact R actually improves post-surgical immunity or reduces the likelihood of infection, and if so, what is the optimum quantity for daily ingestion. This trial aims to clarify both the ingestion amount and its benefits.

  (Approved on 1st May 2003 by Wakayama Medical University Ethics Committee: No. 196)

The effect of pretreatment of the intestinal tract with pre-surgery antibacterial drugs, in regard to post-surgical perineal wound infection after rectal amputation - Randomized clinical trial -

  The rate of infection of the perineal wound subsequent to abdominoperineal resection is relatively high, at between 10 and 60% (averaging 40%), due to the fact that a large number of infection-causing bacteria are indigenous within the large intestine, leading to a strong possibility that the operative field may be contaminated with said bacteria, and the fact that during lymph node resection and extended resections the pelvic cavity becomes a dead space. Furthermore, the infection of the perineal wound can lead to extended time in hospital post-surgery, or wound pain after leaving hospital, and may worsen QOL. As a result, it is necessary to clean the interior of the large intestine prior to surgery, but inhibiting intestinal bacteria with oral antibacterials can change the bacterial flora within the intestines, with the result that bacteria that are hard to treat with post-surgical antibacterials are increasingly detected as the cause of infection of the operative field. Consequently it has become common for internal intestinal washing to be carried out mechanically, using oral intestinal washing agents. More recently, however, the administration of antibacterial drugs for a short period on the day before surgery has been reported not to promote the increase of resistant bacteria, and to inhibit the onset of post-surgical wound infection. It is still no clear, however, exactly to what extent the administration of oral antibacterials prior to surgery blocks peritoneal wound infection  subsequent to rectal amputation. This clinical trial aims to study the extent to which the administration of antibacterials prior to surgery can block the onset of peritoneal infection.

( Approved on 17th January 2003 by Wakayama Medical University Ethics Committee: No. 181)

The effectiveness of peripheral parenteral nutrition method combining lipid emulsion subsequent to moderately invasive surgery

  Post-surgery, there are two major forms of nutritional management – parenteral nutrition, using high-calorie fluid administration, and peripheral parenteral nutrition, using peripheral formula. Parenteral nutrition requires the insertion of a central vein catheter, which is often accompanied by complications either during insertion or through infection while managing nutrition. At the same time, peripheral parenteral nutrition methods rely on osmotic pressure, with the result that it is not possible to administer the ideal number of calories, calculated base on base metabolism. As a result it cannot be used if the patient is required to be non-per-oral for a week or longer. Lipid emulsions, however, which are designed to infuse fat into the veins, have more than twice the calories per unit of sugars and amino acids, and are  therefore effective in supplying calories via peripheral parenteral nutrition, without the concerns relating to osmotic pressure. Lipid emulsions are used within the body at a slow rate, and can give rise to hyperlipidemia, while at the same time their impact on the immune system has meant that doctors were hesitant to use them immediately post-surgery, but by maintaining administration speed, we have found that it is possible to prevent such side effects. This study implements the combined administration of lipid emulsions in peripheral parenteral nutrition to patients who had undergone surgery for digestive organ conditions and were required to be non-per-oral for one week or more, and evaluated post-surgical nutritional indicators and activity levels in the early stages after surgery, with the intention of comparing the effectiveness with that achieved by parenteral nutrition using sugars and amino acids.

(Approved on 17th January 2003 by Wakayama Medical University Ethics Committee: No. 180)

Study of reconstruction methods in pylorus-preserving pancreaticoduodenectomy

  In cases where the pancreas head is to be resectioned, at this hospital our first choice is to perform a pylorus-preserving pancreaticoduodenectomy, which preserves the entire stomach and thereby improves meals and nutrition post-surgery, but one complication of this can be delayed gastric elimination, in other words, after the operation, gastric fluid and food does not pass to the intestines. Patients with this complication require a tube to remove gastric fluid for a week or more, and in some cases are not even able to take solid food two weeks later. In order to improve this delayed gastric elimination, we have obtained the cooperation of our patients undergoing surgery to randomly divide them into two groups and either connect the small bowel to the duodenum 1) in front of the colon or 2) behind the colon. As a result, 50% of patients who were in the group where joining was  implemented behind the colon achieved elimination, while only 5% of the patients in the group where joining was implemented in front of the colon achieved elimination post-surgery, a significantly smaller proportion, and it was clear that  joining behind the colon allows patients to leave hospital sooner. The results of this study are due to be published in the American surgical journal Annals of Surgery.

( Approved on 19th April 2002 by Wakayama Medical University Ethics Committee: No. 149)

The significance of drain insertion in laparoscopic bladder extirpation

  Conventional treatment for gallstones has involved opening the abdomen and removing the bladder, but nowadays almost all such operations are carried out laparoscopically. In many institutions, a drainage tube is inserted into the abdominal cavity for a minimum of two days to provide information in case bile leaks or bleeding occurs subsequent to the laparoscopic surgery. In fact, bile leakage and bleeding are extremely rare post-surgery, and it is considered by some that the insertion of the tube is merely prolonging post-surgical pain. For this reason, we implemented a randomized grouping of cases into those (1) undergoing surgery in which a tube was inserted and (2) undergoing surgery without tube insertion. The results showed that inserting the tube triggers significant pain, and may cause the outbreak of post-surgical infection. Based on these results, we now implement laparoscopic bladder extirpation without the insertion of a tube as standard.

( Approved on 19th April 2002 by Wakayama Medical University Ethics Committee: No. 144)

Interferon monotherapy after hepatic cell cancer treatment, and its relationship to survival rates and recurrence / Study of the effectiveness of combined interferon + ribavirin treatment

  Hepatic cell cancer treatment ideally involves resection, providing liver function is good, but unfortunately, even if the liver is completely resected, recurrence occurs in around 25% of cases one year after surgery, and 50% of cases three years after surgery. The cause of this is believed to be viruses, typically Hepatitis C. In fact, reports indicate that interferon therapy can inhibit early recurrence, and we have further studied the benefits, in terms of recurrence inhibition, of combining an antiviral, the administration method for which has been established, with interferon, to treat the viral hepatitis that is the genesis of  hepatic cell cancer. Post-surgery, however, many patients develop anemia and a decrease in platelet count, with the problematic result that antiviral drugs cannot be administered for a certain period, and ribavirin administration is ceased. We plan to add further studies in the future with the aim of inhibiting Hepatitis C.

( Approved on 18th January 2002 by Wakayama Medical University Ethics Committee: No. 129)