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Botulinum toxin (BTX) is an extremely potent poison which interacts selectively with cholinergic neurons to inhibit the release of neurotransmitters. Local intrasphincteric injection of BTX has been suggested as possible therapy for several spastic disorders of the gastrointestinal tract.There is good evidence for the clinical benefit of BTX injection as an alternative treatment for achalasia and chronic anal fissures. Other possible indications for BTX injection such as sphincter of Oddi dyskinesia or cervical achalasia remain to be further established. BTX injection showed no severe side effects when compared to other interventional or operative treatment alternatives. However, the effect of BTX injection lasts only for several months and is fully reversible. The time-limited effect of BTX is a disadvantage in the treatment of achalasia. By contrast, the limited effect is advantageous in the treatment of chronic anal fissures as the normal function is restored after the lesion has healed and the BTX effect disappeared. The use of BTX has added a new therapeutic concept with few side effects to our interventional methods. When applied critically, this method can be used with benefit for the treatment of our patients.

Endoscopic manometry of the sphincter Oddi (SO) is a sophisticated method which requires a cooperative patient. Therefore, during endoscopic manometry sufficient i.v. sedation is crucial, and additionally must no affect SO-motility. In a pilot trial SO-motility was determined in ten patients with suspected SO-dysfunction (SOD) under initial sedation with 4.8 +/- 1 mg midazolam (baseline), and 3 min after an i.v. bolus of 50 mg of propofol. In addition, endoscopic manometry was performed in 57 consecutive patients with suspected SOD from 10/94-9/95 under sedation with midazolam (6.2 +/- 1.6 mg), and from 10/95-9/96 with propofol (268 +/- 111 mg). Sedation was always performed by an independent physician according to a standardized protocol. Neither the SO-baseline pressure nor the parameters of phasic SO-motility were significantly altered by propofol (including two patients with proven SOD). Propofol causes a more rapid onset of sedation, and the time interval to obtain successful biliary cannulation was shorter than under midazolam (p0.05). Successful manometric recordings could be obtained in 82% of the patients under midazolam but in 96% of the patients under propofol-sedation (p0.05), respectively. The patient cooperation was significantly better rated (by the endoscopist) in the propofol group than in the midazolam group (p0.01). The blood pressure and the heart rate were not significantly affected in both groups, however, propofol caused a significant decrease of the oxygen saturation (p0.05). Accordingly, an apnea episode had to be mastered by mask ventilation via ambu bag in one patient under propofol-sedation (uneventful recovery). In the midazolam group flumazenil-administration was necessary in four patients. The post-procedure recovery was faster after propofol--than after midazolam-sedation (p0.05). In conclusion, propofol is suitable for i.v. sedation during endoscopic manometry of the spincter of Oddi.

An increased incidence of pancreatitis having been reported after endoscopic manometry (EM) of the sphincter of Oddi, its incidence and severity as well as potential risk factors were investigated prospectively.Between June 1988 and June 1996, standardised manometry was performed in 207 patients with suspected biliary and 23 with suspected pancreatic sphincter of Oddi dysfunction (SOD). All patients had been observed in hospital for at least 24 hours before the test. The diagnostic criteria of post-manometric pancreatitis (PMP) were epigastric pain and a rise in the concentration of serum amylase to at least three times normal. Potential risk factors for PMP were elucidated by uni- and multivariate analysis.Pancreatitis occurred in 19 patients (9%) with suspected biliary and in 6 (26%) with suspected pancreatic SOD (P0.01), 17 of mild and 8 of moderate degree. There were no deaths and no lasting sequelae. Previous pancreatitis after endoscopic retrograde cholangiopancreatography and the presence of SOD were identified as patient-associated risk factors (P0.01 for each). Method-associated risk factors were duration of manometry of more than 5 min (P0.05) and manometry in the pancreatic duct system (P0.05). The risk of pancreatitis was reduced by simultaneous endoscopic sphincterotomy for SOD (P0.01).Specific and often avoidable risk factors for postmanometric pancreatitis were identified: technical procedure, pancreatitis, SOD. With short duration of manometry, avoiding of manometry in the pancreatic duct system and with patient's informed consent for simultaneous endoscopic sphincterotomy risk of pancreatitis may be lowered.

A noninvasive test to prove sphincter of Oddi dysfunction is desired, because endoscopic manometry is technically demanding and not without risks.40 consecutive patients (n = 20 patients with, and n = 20 patients without enzymatic cholestasis) with suspected SOD were investigated both by ultrasonography (US; 3.5 MHz) and by endoscopic manometry. SOD was suspected at US if the extrahepatic bile duct diameter wasor = 9 mm and a further increase (at least0.5 mm) was observed after intravenous ceruletide (0.3 micrograms/kg b.w.). SOD was verified manometrically by a sphincter of Oddi basal pressureor = 40 mmHg. Endoscopic sphincterotomy was performed if SOD was diagnosed by manometry. Thereafter, all patients were enrolled in a prospective follow-up (median: one year).At US SOD was suspected in eleven of 20 patients with cholestasis. SOD was confirmed manometrically in all of them but also in two further patients (13 of 20 patients with proven SOD). After EST twelve of 13 patients remained free from biliary symptoms. In the 20 patients without cholestasis SOD was suspected at US in five patients only. However, endoscopic manometry revealed SOD in eleven of 20 patients and proved sonographically presumed SOD in only three of five patients. After EST only three of eleven patients remained asymptomatic during follow-up (p0.05 vs. patients with cholestasis). Clinically important side effects were not observed after ceruletide administration, whereas postmanometry pancreatitis was observed in three of 40 patients.In patients with recurrent symptoms after cholecystectomy and enzymatic cholestasis SOD was reliably diagnosed by ultrasonography (sensitivity: 85%, specificity: 100%), and this finding may guide endoscopic sphincterotomy.

Esophageal and anorectal motility have not been systematically evaluated in patients with sphincter of Oddi dysfunction (SOD). We have investigated 8 consecutive patients (6 females, 52.5 +/- 9.5 y) with type I-SOD (according to the Milwaukee-classification), 12 patients (9 females, 50.4 +/- 12.3 y) with type III-SOD, and 20 healthy volunteers (15 females, 48.5 +/- 15.2 y) by means of a standardized questionnaire for esophageal and anorectal symptoms, esophageal manometry, colonic transit time evaluation, and anorectal manometry. Symptom-scores did not differ significantly between type-I and type III-SOD-patients, respectively. Furthermore, there were no relevant differences of the symptom-scores of the SOD-patients vs. healthy subjects. However, the lower esophageal sphincter pressure (LESP) was significantly higher in patients with type I-SOD (26.8 +/- 7.4 mmHg) than in both, type III-SOD-patients (20.3 +/- 4.0 mmHg, p0.05) and healthy subjects (18.6 +/- 3.5 mmHg, p0.001), respectively. Mean colonic transit time did not differ significantly between both groups of patients (type I-SOD, 27.9 +/- 21.4 h, vs. type III-SOD, 28.5 +/- 15.1 h, p0.05). The anal sphincter resting pressure (ARP) was significantly higher in patients with type I-SOD (90.8 +/- 15.5 mmHg) than in healthy subjects (74.1 +/- 10.3, p0.01), but did not differ significantly from that in patients with type III-SOD (82.1 +/- 11.5 mmHg, p = 0.17). Computer-assisted "beat-to-beat"-evaluation showed an abnormal heart rate variability in 3/8 patients with type I-SOD. These results give evidence for a systemic involvement of the lower esophageal and the anal sphincter in patients with type I-SOD, which does not occur in patients with type III-SOD.

As the pathogenesis of acute recurrent pancreatitis remains unclear in 30% of patients, it was the aim of this study to find out whether and how often changes in sphincter of Oddi motility is present in these patients and whether endoscopic treatment promises success.18 patients (three men, 15 women; mean age 41.5 [30-56] years) with "idiopathic" acute recurrent pancreatitis seen consecutively between April 1991 and November 1995, were included in the study. In none had laboratory examinations, sonography, computed tomography and endosonography (n = 11) demonstrated any unusual findings. Neither exocrine (pancreaolauryl test in 8, secretin-pancreozymin test in 10 patients), nor endocrine (oral glucose tolerance test) pancreatic insufficiency had been found. Endoscopic retrograde cholangiopancreatography had excluded morphological changes in the biliary-pancreatic system. All patients underwent endoscopic manometry. When a basal sphincter of Oddi pressureor = 40 mm Hg was demonstrated in the pancreatic sphincter segment, combined endoscopic sphincterotomy was done of both the biliary and the pancreatic component.Nine patients had a raised basal sphincter pressure in the pancreatic segment of the sphincter, but in only four in the biliary one as well. The phasic sphincter motility was normal in all patients. In four patients iatrogenic pancreatitis developed after the procedure (mild in three, moderately severe in one). Eight of the nine patients who had a sphincterotomy remained symptom-free during a mean follow-up period of 21 months, but only three of the nine with normal manometric findings.Half of the patients with acute recurrent pancreatitis of unknown cause have sphincter of Oddi dysfunction, usually limited to the pancreatic segment of the sphincter, Endoscopic sphincterotomy can prevent recurrent pancreatitis in most of the patients.

Dysfunction of the sphincter of Oddi may be a cause of persistent problems after cholecystectomy. The aim was to find out whether various factors are of value in predicting abnormal manometric results and thus aid in deciding whether endoscopic manometry is indicated.97 patients were investigated prospectively (13 men, 84 women; mean age 50.2 [29-72] years) in which endoscopic cholangiopancreatography (ERCP) had not revealed any cause of the biliary complaints. The patients were divided into three types according to four criteria: (1) history (biliary colics); (2) biochemistry (cholestasis); (3) dilated biliary tract (at ERCP); (4) contrast retention in biliary tract (at ERCP). Type I: all four criteria present; type II: positive history and one or two other criteria; type III: biliary colic only. Endoscopic manometry (EM) was performed after classification of the patients.EM was successful in 83 of 97 patients (86%). All 15 patients of type I had sphincter of Oddi dysfunction (SOD) defined as basic sphincter pressure40 mm Hg. SOD was demonstrated in only 23 of 38 patients of type II (61%) and 15 of 30 patients of type III (50%) (P0.01). Increased rate of sphincter of Oddi contraction ("tachyoddi") was demonstrated in only four patients (4%), in two of them in combination with an increased basic sphincter pressure. Mild to moderate pancreatitis occurred within 24 hours of manometry in ten of 83 patients.Endoscopic manometry is not necessary in patients of type I for confirming the diagnosis. But it is obligatory for patients of type II and III, because the demonstration of SOD has therapeutic consequences, and should be performed in clinical studies, if possible.

Endoscopic manometry and quantitative cholescintigraphy are the diagnostic cornerstones for the detection of suspected sphincter of Oddi dysfunction. In patients with recurrent biliary pain after cholecystectomy, endoscopic manometry proves an elevated sphincter of Oddi baseline pressure as the most common finding. The probability for the detection of an elevated baseline pressure in these patients is significantly correlated with the presence of certain clinical features (i.e. biliary pain and/or cholestasis and/or dilated bile duct and/or delayed drainage of contrast material after ERCP). Therefore, these features enable a clinical classification of patients with suspected sphincter of Oddi dysfunction. Isolated baseline pressure elevations in the pancreatic portion of the sphincter of Oddi were reported in patients with recurrent, idiopathic, acute pancreatitis. In patients with biliary sphincter dysfunction, therapeutic relief can be expected from pharmacological therapy, but controlled studies are lacking. However, the clinical value of endoscopic sphincterotomy could be established in this field. Despite endoscopic manometry is not a prerequisite for the performance fo endoscopic sphincterotomy in every case of suspected sphincter of Oddi dysfunction, in most patients endoscopic manometry allows the only definitive diagnosis of sphincter dysfunction. Further on, the clinical value of semi-invasive methods as alternative treatment strategies (i.e. botulinum-toxin, transcutaneous electric nerve stimulation, balloon dilation) for sphincter of Oddi dysfunction has to be evaluated in the future.

In 1987 it was demonstrated that the vascular endothelium produces nitric oxide, a gas that acts as highly labile but very potent relaxing factor for the vascular smooth muscle. During the last 5-6 years, a series of discoveries from many different avenues of research came together revealing the major biological role of NO as neurotransmitter in the nervous system and other parts of the body, as a potent vasodilating and cytoprotective substance, as mediator of endotoxin-induced cytotoxicity and as a substance involved in various disorders such as liver cirrhosis and reactions of the immune system. Recent studies suggest that in addition to VIP and ATP, NO may mediate non-adrenergic, non-cholinergic (NANC) inhibition of gastrointestinal smooth muscle and related inhibitory junction potentials. The identity of action of NO and NANC nerve stimulation has been supported by numerous in vitro and in vivo studies on esophagus, stomach, small intestine and colon of various species including humans.

Sphincter of Oddi activity partly regulates bile flow into the small intestine. This regulation is mainly controlled by phasic contractions and basal tone of the sphincter, together with gallbladder contraction. Manometric studies of the sphincter have permitted a better understanding of its physiological role and implication in biliary dyskinesia symptoms. Motility abnormalities of Oddi's sphincter present classically as bouts of recurrent pain and/or idiopathic pancreatitis, that can be successfully cured by endoscopic sphincterotomy.

Pirenzepine (Gastrozepin) has a proven positive effect in the treatment of peptic ulcers by blocking the so called muscarinic acetylcholine receptors of the gastric glands. Reports of positive results with pirenzepine in the treatment of acute pancreatitis led to new discussions about its biological effects. It is thought that there are three ways by which pirenzepine acts in the pancreas. It decreases enzymatic secretion and it increases the secretion of sodium bicarbonate and water. Furthermore, it is said to have a spasmolytic effect on the sphincter of Oddi. To prove this spasmolytic effect we performed endoscopic manometry at the sphincter of Oddi with intubation of the pancreatic duct in 12 healthy patients. After two minutes of manometric registration of the normal sphincter activity 6 patients received 10 mg pirenzepine i.v. while a control group of 6 patients received 2 ml of 0.9% NaCl i.v. During the next 5 minutes the basal pressure of the sphincter, the amplitude of concentrations, as well as their frequency and duration were monitored. There were no changes noticed in the placebo group. However, pirenzepine caused a considerable decrease of the 4 manometric parameters of the sphincter of Oddi in all patients. Within 5 minutes the basal tonus fell from 14.3 +/- 5.1 mm of mercury to 9.0 +/- 6.0 (p less than 0.01). The frequency of contractions dropped from 5.8 +/- 2.7 per minute to 2.0 +/- 2.1 (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

The development of potent and specific CCK-receptor antagonists made it possible to evaluate the physiological role of CCK for various gastrointestinal functions. The results of these studies show that CCK is the hormone which principally mediates meal-induced gallbladder emptying. In addition, CCK appears to play an important role in maintaining the fasting muscular tone of the gallbladder. In contrast, CCK-antagonists could inhibit only about 50% of the meal-stimulated pancreatic exocrine secretion. Because of their marked relaxing effect on the gallbladder, CCK-antagonists might become an important clinical tool for treatment of gallbladder spasms and colics. On the other hand, long-term application of CCK-antagonists will increase the risk of stone formation in the gallbladder. CCK-antagonists also had beneficial effects in some animal models of acute pancreatitis. As yet, it is unclear whether CCK-antagonists might become useful for the treatment of human pancreatitis. Since CCK-antagonists only slightly inhibited pancreatic growth, it is unlikely that they will exert major inhibitory effects against growth of pancreatic carcinoma. CCK-antagonists failed to alter gastric emptying of a normal mixed solid-liquid meal, but accelerated gastric emptying of purely liquid meals. Thus, CCK-antagonists are not likely to become useful agents to treat alterations of gastric emptying. The studies with CCK-antagonists further showed that CCK plays only a minor role in the regulation of the motility of the small and large intestine. CCK is probably not involved in the regulation of the gastrocolonic response after a meal. Some reports indicate that CCK-antagonists might increase colonic transit and might therefore be useful to treat constipation.

In up to 30% of cases of the so-called postcholecystectomy syndrome functional disturbances of the sphincter of Oddi are responsible for the clinical picture. These pathological changes in pressure and motility at the sphincter can be identified by means of endoscopic manometry. We found dysfunction of the sphincter of Oddi in 4 out of 10 patients with so-called postcholecystectomy syndrome. In 2 patients in whom the basal pressure was higher than 40 mmHg endoscopic papillotomy was performed, after which the patients remained symptom-free. In one case tachyoddi was diagnosed and in another case the proportion of retrograde sphincter contractions exceeded 50%. Endoscopic manometry at the sphincter of Oddi enables many of the as yet unclarified postcholecystectomy symptoms to be identified.

Problems of the diagnosis of Oddi's sphincter dysfunction are discussed based on experiences gained mostly in cholecystectomized patients. In every case the existence of an organic lesion interfering with free bile flow was ruled out. The functional nature of the lesion was verified by using the morphine-choleretic test combined with either dynamic hepatobiliary scintigraphy or percutaneous transhepatic cholangiography. Illustrative cases are demonstrated.

The pathophysiology, diagnosis and therapy of biliary motility disorders are surveyed on the basis of the literature and own experience. Bile duct dyskinesia is clinically characterised by pain of biliary and sometimes pancreatic type evoked by meal or psychogenic influence. A prerequisite of the diagnosis is the exclusion of any organic origin of the complaints. In the routine clinical practice Oddi's sphincter dyskinesia can be diagnosed by the simultaneous assessment of the response to a provocation test and the therapeutic effect of a sphincter-relaxant, e.g. nitroglycerine. For differentiating between papillary stenosis and dismotility the endoscopic manometry and radiopharmacological methods are of greatest value. The cystic duct dyskinesia can be recognized with the help of cholecystokinetic provocation test and on the basis of therapeutic response to nitrite derivates. The therapy of the biliary dyskinesia includes influence on the evoking dietetic and psychic factors and administration of long-acting sphincter relaxants as well. In failure of the conservative therapy the complaints caused by Oddi's sphincter dyskinesia and cystic duct dyskinesia can be abolished by endoscopic or surgical sphincterotomy and cholecystectomy, respectively.

Ten patients with common bile duct stones not removable by endoscopic measures after sphincterotomy were treated by extracorporeally generated shock waves. In 9 patients stones up to 30 mm in diameter were disintegrated. Two patients became free of stone fragments spontaneously within one day and in 7 patients the stone fragments were extracted endoscopically. No complications occurred. Extracorporal shock wave treatment represents a promising alternative to surgery in cases where common bile duct stones cannot be extracted endoscopically.

Treatment was required in nine cases (1.7%) of haemorrhage after endoscopic sphincterotomy performed in 508 patients during 1981/82. Infiltrations with adrenalin (1: 10 000) and 1% polidocanol solution resulted in immediate arrest of haemorrhages in all cases. The endoscopic intervention could thus be completed successfully without further delay. The haemostatic effect was, without exception, permanent. There were no specific complications or late reactions.

In spite of immaculate surgical technique conventional transduodenal sphincterotomy is attended by a non-lethal complication rate of about 5.8% and a mortality rate of about 4.5%, the most frequent cause being dehiscence of the duodenal suture. The primary and secondary pathogenesis hereof is explained by the particular predisposition duodenal laceration on account of its special anatomy and operative vulnerability. Bearing these facts in mind, the method of so-called perduodenal sphincterotomy (p. sph.) seemed to offer more promising results for the following reasons: 1. Splitting of the sphincter through a minute incision in the duodenum (stab incision with a tenotome). 2. The advantage of primary closure of the cystic duct in the transcystic approach with medium-sized probes for the splitting. Experimental evidence shows the cystic duct to be very resistent towards dilation and rupture, especially in the presence of inflammatory processes. From 1967 to 1973 in 1441 cases of gall-bladder surgery p. sph. was performed 374 times and transduodenal sphincterotomy only 121 times. The statistic evaluation of the outcome of both methods showed significantly better results with p. sph. with regard to the incidence of postoperative non-lethal complications and duration of hospitalization. Assessment of non-lethal postoperative mortality and follow-up studies on 79% of the operated patients over a period from 3 to 9 years showed that the results of both methods were equal. In our experience the p. sph. is not only advisable when sphincterotomy is generally indicated, but also in the following special situations: a) as so-called "emergency papillotomy" in poor-risk patients; b) if the transduodenal approach is impossible awing to technical difficulties (poor accessibility, low site of the papilla); c) if the indication for papilotomy is dubious it can be chosen as the less dangerous method; d) for reoperation on the sphincter. On account of its prevailing advantages this new method for repairing papillary drainage is practicable as a routine method in sphincteric surgery.

Besides the high diagnostical value of the electromanometric measurement, this method is especially useful for the registration of pharmacological effects upon the sphincter of Oddi. In this study the influence of hymecromon on sphincter function was tested in 138 patients. Hymecromon induced a significant decrease of pressure by prolonging the opening time (p0.001). In clinical experiments it could be shown that the increase of pressure induced by morphine in the common bile duct could be equalized by hymecromon within a short time. Depending significantly on the dosage (p0.01) there were identical results on the intravenous or intraductal application of hymecromon. An increase of activity of the liver-specific enzymes could not be seen after hymecromon treatment.

Endoscopic sphincterotomy is a new procedure for the management of extrahepatic cholestasis. The main indications are residual or recurrent common bile duct stones and papillary stenosis. In high risk patients endoscopic sphincterotomy is the procedure of choice even in the absence of previous cholecystectomy. In these cases especially, mortality is considerably lower compared to surgical therapy. Sphincterotomy is successful in more than 90% of patients, and in about 85% passage of common bile duct stones occurs. Follow-up studies have thus far revealed no significant adverse effects.

The percutaneous transhepatic catheterisation is an important method in the management of obstructive jaundice. The results of the percutaneous transhepatic drainage - external and internal - in 14 patients are reported. The technique is described and the difficulties, complications, indications and contraindications are discussed. The value of this procedure is the temporary decompression of the obstructed biliary tract prior to radical surgery or as a palliation in patients with non-operable tumors; the risk of the procedure is low.

The action of acute and chronic administration of ethanol on pancreatic exocrine secretion in humans and several animal species is reviewed. If the data concerning the secretory action of ethanol on the pancreas are to the property assessed, several experimental variables have to be considered. Acute intravenous administration of ethanol inhibits basal and hormonally stimulated pancreatic secretion of bicarbonate and protein in nonalcoholic humans and most species of animals tested. Oral or intraduodenal ethanol causes moderate stimulation of pancreatic bicarbonate and enzyme secretion. Since anticholinergic agents and truncal vagotomy diminish the ethanol-induced inhibition of pancreatic secretion in the intact animal, it is possible that the action of ethanol on the pancreas is at least partly mediated by inhibitory cholinergic mechanisms. The action of ethanol on the pancreas may also be mediated by release of gastrointestinal hormones. Intravenous and oral administration of ethanol releases gastrin in dogs but not in humans. Pancreatic polypeptide is unlikely to be the hormonal mediator of the ethanol-induced inhibition of exocrine pancreatic secretion in humans and dogs, since ethanol does not release pancreatic polypeptide. The main secretory changes induced by chronic alcoholism in humans and dogs are increased basal secretion of pancreatic enzymes and decreased basal bicarbonate output, and these secretory changes may favour the occurrence of protein precipitates which are believed to be the first lesion of chronic pancreatitis in man. A decrease in the concentration of "pancreatic stone protein" in pancreatic juice may favour the development of protein precipitates in chronic alcoholic patients.

The influence of several anaesthetic methods on the tonus of the sphincter of Oddi was investigated in 45 selected patients undergoing cholecystectomy (halothane; fentanyl; fentanyl-droperidol (DHB); all in combination with N2O:O2 and relaxant). The fentanyl collective showed a significant rise of the common bile duct pressure, while the fentanyl-DHB and the halothane collectives did not show any statistical difference in their parameters. From these results neuroleptanalgesia appears to be a surtable method for biliary surgery.

During the last years the endoscopic perfusion manometry developed many new recognitions about the courses of pressure and motility at the sphincter Oddi. The clinical and experimental application of the method concentrated itself to the proof of functional disturbances. Many results are contradictory and a whole series of questions is unsolved. The own investigations concentrated themselves on pressure measurements in the common bile duct in patients with removed gallbladder, in whom by comprehensive diagnostic measures no organic disease of the biliary tract could be found. Two groups of patients were compared. Patients of group 1 (n = 14) had no biliary symptoms after cholecystectomy. The patients of the second group (n = 20) continued to have biliary complaints after cholecystectomy, or they again occurred after symptom-free interval. At the beginning of the investigation the pressure in the common bile duct was the same in the two groups. In group 1 the pressure remained constant also during the manometry and the patients remained without any complaints. However, in group 2 a gradual increase of pressure and biliary complaints developed during manometry. These occurred after an average pressure increase of 8 Torr. The velocity of the increase of pressure well correlated with the intensity of the complaints. The symptoms during manometry were identical with those cited in the anamnesis. The pressure increase in the common bile duct is regarded as an expression of a functional disturbance of the sphincter of Oddi. The constant perfusion rate (1.3 ml/min) in this group of patients is sufficient as volume load, in order to detect a disturbed drainage capacity of the papilla. On its part the increase of the pressure is responsible for the evocation of the complaints.

A well-functioning major duodenal papilla is an indispensable condition for freedom from complaint in the region of the biliary tract and pancreas. Intraoperatively, the papilla is the problem of the surgeon. With appropriate morphological changes, transduodenal papillotomy is a necessary and irreplaceable procedure for curing the bile ducts and the pancreas. It should, however, be strongly emphasized that this surgical papillotomy is a major intervention bearing a number of possible risks. For this reason, only the sufficiently functionally disturbed and morphologically altered papilla is to be operated on.

While extending the papilla duodeni of dogs by probes of increasing diameter, mural pressure was measured as an equilibration of the hydrostatic pressure within the probes along a distance of 12 mm. Pressure-diameter-curves at the duodenal end of the papilla show the mural pressure promptly increasing to a maximum when partially extended, then declining and rising again when extended extremely. Proximal to the papillary end the mural pressure first declines and then continuously increases with larger probe diameters. The pressure-diameter-curve of the papillary end resembles the length-tension-diagram of isolated smooth muscle in vitro, and represents the normal physiological action of the sphincter zone.

A multicenter study of 25 centers covering 9041 endoscopic sphincterotomies showed that choledochal concrements still represent the main indication (83,9%). Circumscript papillary stenosis (10.64%) and papillary tumour(2.06%) are the next most frequent indications. Complications after endoscopic sphincterotomy may be expected in 7.55% of cases, somewhat more frequent after papillary stenoses than after choledochal concrements. The most frequent complication is haemorrhage, followed by pancreatitis, cholangitis in cases of choledochal concrements, and perforation. Mortality is around 1.12%. Late results after endoscopic sphincterotomy a satisfactory and concrement-free bile ducts are seen in 91.62%. Freedom of complaints or improvements of symptoms occur in 93.4%. Recurrent stones occur in 5.77%, restenoses were seen in 3.14%. Late results after endoscopic sphincterotomy ar worse in papillary stenosis than in choledocholithiasis. Mortality figures are twice as high and danger of perforation seems to be more frequent. Endoscopic sphincterotomy is done increasingly as an emergency measure.

70 patients who underwent transduodenal sphincterotomy for stenosis of the papilla of Vater 2 months till 15 years ago, were re-examined. The lab results as well as the histological examination of liver biopsies and the ERC gave no reference of bile duct-or liver damage.

In a collective series of 18,422 successful EPT, early complications occurred in 7.63% of cases with a mortality rate of 0.93%. EPT for benign stenosis of the sphincter of Oddi was followed by the highest morbidity. Late complications were observed in 5.1% of 6054 patients followed during more than 6 months, most of them during the first year of follow-up. Non surgical treatment was possible in 77.5% of early complications and 74% of late complications with respective mortality rates of 12.1% and 27.4%.

2225 operations for gallstones were performed, from 1961 to 1972 and ended 397 times with choledocho-duodenostomy, 249 times with T-drainage and 84 times with sphincteroplasty. Only risky patients underwent an anastomosis. The mortality rate in all 3 procedures came up to 2.3 to 2.4%. Choledocho-duodenostomy proved to be a useful method especially in old aged people and patients with a high operative risk.

Since 1977 endoscopic sphincterotomy has been indicated in 18 patients because of benign papillary stenosis. In 17 patients cholecystectomy had been performed some time before. The sphincterotomy was successful in 15 patients. In one patient slight bleeding occurred. In 2 of 3 patients in whom sphincterotomy did not succeed, the endoscopic procedure was complicated by cholangitis and pancreatitis respectively. 12 of the 15 patients in whom sphincterotomy was successful were symptom-free over a median period of 21 months. Therefore, endoscopic sphincterotomy appears to be an effective treatment for benign papillary stenosis and is a low-risk procedure compared with surgical sphincterotomy.