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Intralesional injection of OK-432 was employed to treat 64 lymphangiomas between 1986 and 1992. This was used as primary therapy for 46 lesions (group A), as treatment following incomplete surgical removal in 14 (group B), and as therapy after failure of bleomycin in 4 (group C). In group A (n = 46), total shrinkage of the lesion, without serious complications, was noted in 23; there was marked shrinkage in 8, slight shrinkage in 12, and no response in 3. Of the cystic lesions (n = 24), significant shrinkage occurred in 22; of the cavernous lesions (n = 22), only 9 improved after treatment. In groups B (n = 14) and C (n = 4) there was significant clinical improvement occurred in 5 and 2, respectively. No recurrence was noted during follow-up (6 to 87 months). The only side effects were fever lasting 2 to 4 days and a local inflammatory reaction of 3 to 7 days' duration. The local inflammation did not cause any damage to the overlying skin and did not lead to scar formation. These data suggest that intralesional injection of OK-432 is effective treatment for lymphangiomas and should be considered as the primary method of treatment.

To avoid surgery-related complications, intralesional OK-432 therapy was used in 23 patients with unresectable lymphangiomas (1986 through 1989). Total or near total shrinkage of the lesions, without serious complication, was noted in 10, marked shrinkage in 8, slight shrinkage in 3, and no response was noted in the remaining 2. Recurrence of the lesions has not been observed during follow-up (4 to 35 months). The side effects of OK-432 therapy were a fever for 2 to 3 days and a local inflammatory reaction lasting 3 to 5 days. The local inflammation did not cause any damage to the overlying skin and did not lead to scar formation. The results suggest that intralesional OK-432 therapy is effective for most unresectable lymphangiomas.

Functional results after surgical correction of anorectal malformations were assessed on a clinical basis following Kelly score, by manometric and radiologic studies. Sixty-five patients, older than 5 years, were personally interviewed and 51 of the 65 had manometric and radiologic studies to evaluate postoperative continence. Continent patients with high type lesions as well as those with low type lesions characteristically had a marked anorectal pressure difference and an acute anorectal angulation in the defecogram. On the other hand, in the patients with fair or poor results, neither a marked anorectal pressure difference nor anorectal angulation was found. These results indicate that achievement of continence in patients with a high type lesion treated by staged abdominoperineal rectoplasty depends upon bringing the terminal bowel down exactly within the sling of the puborectalis muscle.

To determine a favorable treatment for lymphangiomas arising around cervico-facial region, a 10-year (1979, 1-1988, 9) experience with 58 these lesions were reviewed. Therapeutic records were divided into 3 groups according to the treatment: surgical Excision (n = 16), intralesional Bleomycin (BLM) therapy (n = 11), and intralesional OK-432 Picibanil therapy (n = 31). Complete disappearance of the lesions without serious complications was noted in 3 of 16 patients treated by surgery, in 3 of 11 patients treated by BLM therapy, and in 21 of 31 patients treated by OK-432 therapy. Serious complications such as facial nerve palsy (3), ugly scars due to repeated excision (5) and short of tongue (1) were noted in surgically treated group. In BLM and OK-432 therapy groups, only a fever of 2 to 3 days' duration and local inflammatory reaction of 3 to 5 days were noted. The results suggest that OK-432 therapy is effective for these lesions.

Sphincter reconstruction using the gluteus maximus muscle was attempted in a 9-year-old boy who had been incontinent following surgery for the high type of anorectal malformation. Anorectal function following this procedure was assessed by anorectal manometry, defecogram, and electromyography. Postoperative function improved from Kelly 1 (poor) to Kelly 3 (fair). Adequate anorectal pressure difference and good voluntary contraction were documented one year after surgery. A defecogram one month postoperatively showed the presence of an empty segment which had not been noted before. Tonic activity at rest, which had not been present before, was found both one month and one year after surgery. These results indicate that the gluteus maximus muscle maintains some function as a newly created anorectal sphincter. In the present study, the patient was examined periodically for one year after surgery. Further follow-up studies are necessary.

Histochemical and biochemical examinations of rectal biopsy specimens were performed in 13 patients with Hirschsprung's disease and in seven with idiopathic constipation and no megacolon. Serum and erythrocyte acetylcholinesterase (AchE) activity in these two groups was compared with that in 30 normal controls. AchE staining of rectal biopsy specimens proved to be a reliable and convenient diagnostic approach in patients with Hirschsprung's disease. Biochemical assay of AchE activity in rectal biopsy specimens was also of value in the diagnosis, however, there was an overlap between Hirschsprung's disease and idiopathic constipation. Erythrocyte AchE activity correlated well with AchE activity in rectal biopsy specimens. Therefore, assays of erythrocyte AchE activity provided useful additional information, especially in screening tests for Hirschsprung's disease.

The antireflux mechanism of the Nissen fundoplication was investigated in 15 mongrel dogs by esophageal manometry. Nissen fundoplication increased the lower esophageal resting pressure for 2 weeks after operation; however, by 4 weeks it had decreased to a level which did not differ significantly from the preoperative value. Thus, lower esophageal sphincter (LES) length, unlike LES pressure, was maintained for a long period. These results suggest that restoration of competence at the gastroesophageal junction after Nissen fundoplication depends on an adequate length of LES as well as increased LES pressure. The gastrin-stimulated LES pressure 1, 2 and 4 weeks after operation was significantly higher than the preoperative stimulation pressure. Therefore, it seems that the antireflux mechanism is associated not only with the mechanical aspect of the wrapping but also with creation of a new muscular sphincter substitute that reacts sufficiently to gastrin stimulation.

Intraoperative manometry of the biliary tract and measurement of amylase levels in choledochal cysts were performed in seven patients, aged 14 months to 5 years, with choledochal cysts, in an investigation of the pathophysiology of the biliary tract. An abnormal choledochopancreatico ductal junction was observed in these seven patients by preoperative endoscopic retrograde cholangiopancreaticography (ERCP) or intraoperative cholangiograms. All six patients examined showed a high amylase level in the choledochal cyst (5,450 to 46,500 Somogyi Units). The intraoperative manometry of the biliary tract showed that a remarkable high pressure zone as was found in the area of sphincter of Oddi was not found in the area of abnormal choledochopancreatico ductal junction. The pressure recordings also demonstrated that the sphincter of Oddi pressure in the patient with choledochal cyst was increased by gastrin stimulation. On the contrary, no pressure reaction to gastrin or secretin was found in the area of abnormal choledochopancreatic ductal junction. From these results it seems that free reflux of pancreatic juice into the biliary system occurs, and the reflux stream depends upon the pressure gradient between pancreatic ductal pressure and common bile duct pressure because of the lack of a sphincter function at the choledochopancreatico ductal junction.

The distributions of gut hormones in the colon of Hirschsprung's disease were investigated by the peroxidase-antiperoxidase (PAP) immunohistochemical method. Three colonic segments (ganglionic, oligoganglionic, and aganglionic) were stained by the unlabeled antibody enzyme method. The immunoreactivity of vasoactive intestinal polypeptide (VIP) was found to be reduced in the oligoganglionic and aganglionic segments. Antisera to substance P and met-enkephalin demonstrated immunoreactive cells and fibers in the ganglionic segment, whereas these cells and fibers were almost completely absent in the oligoganglionic and aganglionic segments. A similar distribution was seen for the mucosal endocrine cells with somatostatin immunoreactivity. Antisera to neurotensin, motilin, bombesin, and cholecystokinin revealed no immunoreactivity in the normal colon or the three segments. The differences in these peptides between normal and impaired colonal segments may be one of the causes of colon constriction in Hirschsprung's disease.

The distribution of vasoactive intestinal polypeptide (VIP) in the colon of patients with Hirschsprung's disease was investigated by the peroxidase-antiperoxidase (PAP) immunohistochemical method. Three colonic segments, ganglionic, oligoganglionic and aganglionic, were stained by the unlabeled antibody enzyme method. VIP immunoreactive nerve cell bodies, nerve fibers and nerve endings were distributed throughout the ganglionic and oligoganglionic segments. In contrast, the aganglionic segment contained no VIP nerve endings and the number of fibers was reduced. These differences are thought to be a cause of constriction of the colon in Hirschsprung's disease and VIP neurons are therefore believed to participate in the relaxation of smooth muscle.

The pathophysiology of the lower esophagus in 18 patients with hiatus hernia and 15 normal controls was investigated by esophageal manometry and prolonged pH monitoring. Thirteen patients with symptoms of severe gastroesophageal reflux had lower than normal pressures at the gastroesophageal junction. In 5 patients without symptoms, the pressure was normal. Nine of the 13 patients were inadequately controlled by conservative measures and underwent Nissen or Dor-Nissen fundoplication. All were free of esophageal symptoms postoperatively. Fundoplication resulted in a significant increase in the lower esophageal pressure. Prolonged esophageal pH monitoring showed significant improvement in all indices. Hiatus hernia and gastroesophageal reflux are related etiologically. However, further observations are needed to explain the association between reflux esophagitis and hiatus hernia. Nissen and Dor-Nissen fundoplications restored competence to the gastroesophageal junction as judged by esophageal manometry and prolonged pH monitoring.

The effect of gastrin, secretin and prostaglandin F2 alpha on the canine lower esophageal sphincter (LES) after Nissen fundoplication was investigated by esophageal manometry. The gastrin-stimulated LES pressure was significantly higher intraoperatively 2 and 4 weeks after operation than the preoperative stimulation pressure. On the other hand, the prostaglandin F2 alpha-stimulated LES pressure 2 weeks after operation did not differ significantly from the preoperative stimulation value. At 2 weeks after Nissen fundoplication the LES pressure before secretin injection was significantly higher than the preoperative value. However, the LES pressure after secretin injection did not differ significantly from the preoperative stimulation pressure. Therefore, it seems that exogenously administered gastrin, unlike prostaglandin F2 alpha, stimulates the antireflux mechanism after wrapping of the gastric fundus in the Nissen procedure. It was suggested that secretin reacts against the new muscular sphincter substitute created by wrapping of the gastric fundus in the Nissen procedure.