Use of endoscopic ultrasound and stimulated bilary drainage in the diagnosis of cholecystitis and microlithiasis

• US 5,495,851 A
• Filed: 03/23/1995
• Issued: 03/05/1996
• Est. Priority Date: 03/23/1995
• Status: Expired due to Fees

• Current Assignee: Endoscopic Ultrasound Of Virginia, Inc.
• Original Assignee: Roanoke Gastroenterology, P.C.
• Inventors: Dill, James E., Berkhouse, Linda
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/409,177
• Time in Patent Office: 348 Days
• Field of Search: 128/660.01, 128/660.03, 128/662.05, 601/2, 601/4, 604/51, 600/101, 600/160
• US Class Current: 600/439
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61K 49/22 Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations

Abstract

The combined endoscopic ultrasound and stimulated biliary drainage method involves the following steps: inserting an endoscopic ultrasound device within the antrum of a stomach; positioning the endoscopic ultrasound device within the stomach such that the endoscopic ultrasound device is allowed to have a substantially unobstructed view of the gallbladder; activating the endoscopic ultrasound device such that it is capable of detecting whether the gallbladder exhibits any of the following: gallbladder sludge or small gallstones, focal wall thickening, or adhesions about the gallbladder and/or cystic duct; delivering a cholecystokinin analogue intravenously to the human to enable the gallbladder to contract and to produce an ejection fraction of bile from the gallbladder during each contraction thereof; determining the degree of contraction of the gallbladder by means of measuring each the ejection fraction of the gallbladder; and removing the ejection fractions from the patient and analyzing the ejection fractions to detect the presence or absence of calcium bilirubinate and/or cholesterol granules or crystals therein; whereby cholecystitis or microlithiasis of a gallbladder can be diagnosed with an accuracy or sensitivity of between about 90% to 98%.

Claims

1. A method for diagnosing subtle cholecystitis or microlithiasis of a gallbladder in a patient which comprises the following steps:

inserting an endoscopic ultrasound device within the antrum of a stomach;

positioning said endoscopic ultrasound device within said stomach such that said endoscopic ultrasound device is allowed to have a substantially unobstructed view of said gallbladder;

activating said endoscopic ultrasound device such that it is capable of detecting whether said gallbladder exhibits any of the following;

gallbladder sludge or small gallstones, focal wall thickening, or adhesions about said gallbladder and/or cystic duct;

delivering a cholecystokinin analogue intravenously to said patient to enable said gallbladder to contract and to produce an ejection fraction of bile from said gallbladder during each contraction thereof;

determining the degree of contraction of said gallbladder by means of measuring each said ejection fraction of said gallbladder; and

removing said ejection fractions from said patient and analyzing said ejection fractions to detect the presence or absence of calcium bilirubinate and/or cholesterol granules or crystals therein.

2. The method according to claim 1 wherein said cholecystokinin analogue is sincalide.

3. The method according to claim 1 wherein said cholecystokinin analogue is administered in a dosage of about 0.02 to 0.04 micrograms per kilogram of weight of said patient.

4. The method according to claim 1 wherein said ejection fraction of said gallbladder is the percentage of the gallbladder volume or contents that is ejected from said gallbladder during each contraction.

5. The method according to claim 4 wherein said means of measuring each said ejection fraction of said gallbladder and thus determining the degree of contraction of said gallbladder is a microprocessor.

6. The method according to claim 1 wherein said endoscopic ultrasound device generates a transmitted ultrasonic signal which comes into contact with said gallbladder and then returns to said endoscopic ultrasound device as a received ultrasonic signal.

7. The method according to claim 6 wherein said endoscopic ultrasound device comprises a transducer which is capable of both transmitting and receiving ultrasonic signals.

8. The method according to claim 6 wherein said received ultrasonic signal is sent to a signal processor where it is converted to a digitized signal and then sent to a microprocessor.

9. The method according to claim 8 wherein said microprocessor is connected to a video monitor which displays a visual computerized image of said gallbladder, wherein said gallbladder sludge or small gallstones, focal wall thickening, or adhesions about said gallbladder and/or cystic duct can be detected.

10. The method according to claim 1 wherein said ejection fractions of said bile are removed from said gallbladder by means of an aspiration device disposed within said second portion of the duodenum.

11. The method according to claim 10 wherein the presence or absence of calcium bilirubinate and/or cholesterol granules or crystals contained within said removed bile is detected by means of an electronic or optical microscope.

12. The method according to claim 1 wherein said endoscopic ultrasound device within said stomach is positioned such that said endoscopic ultrasound device is allowed to have a substantially unobstructed view of said gallbladder by means of pressing a water filled balloon against the stomach wall.

13. The method according to claim 1 wherein cholecystitis or microlithiasis of a gallbladder in a human is diagnosed if at least one of the following criteria classifications are observed:

(A) two major criteria, (B) one major and one manor criteria, and (C) three minor criteria, wherein said major criteria comprises;

the presence of sludge or small stones in said gallbladder, and the finding of calcium bilirubinate granules or cholesterol crystals in said bile, and wherein said minor criteria comprises;

gallbladder adhesions, cystic duct adhesions, decreased ejection fraction of the gallbladder of less than 35%, and focal gallbladder wall thickening of greater than 2 mm.

14. A method for diagnosing the cause of right upper quadrant abdominal pain in a patient having a gallbladder which is substantially intact comprises the following steps:

(a) conducting a transabdominal ultrasound test, wherein if said transabdominal ultrasound test is positive then the patient would be a good candidate for a cholecystectomy and if normal then go to step (b);

(b) conducting an oral cholecystography test to determined the concentrating ability of said gallbladder, wherein if said oral cholecystography test reveals a decreased concentrating ability then the patient would be a good candidate for a cholecystectomy and if normal then go to step (c);

(c) conducting a combined endoscopic ultrasound and stimulated biliary drainage, utilizing an intravenously delivered cholecystokinin analogue, test if dietary and/or pharmaceutical therapy does not alleviate the right upper quadrant abdominal pain of said patient, wherein if said combined endoscopic ultrasound and stimulated biliary drainage test is positive then said patient would be a good candidate for a cholecystectomy and if normal then go to step (d);

(d) conducting an endoscopic retrograde cholangiography test to determine whether any gallstones are present in the common bile duct, wherein if any gallstones are present then said patient would be a good candidate for a either an endoscopic sphincterotomy or a cholecystectomy and if no gallstones are present then go to step (e); and

(e) conducting a sphincter of oddi manometry test to determine if there is elevated sphincter of oddi basal pressure, wherein if there is at least 40 mm of mercury sphincter of oddi pressure then said patient would be a good candidate for an endoscopic sphincterotomy and if less than 40 mm of mercury then the candidate would be a good candidate for dietary and/or pharmaceutical therapy.

15. The method according to claim 14 further comprising the steps of:

(f) conducting a liver function test, wherein if normal then go to step (a) and if said liver function test is suggestive of biliary stasis then go to step (g);

(g) conducting a combined endoscopic ultrasound and stimulated biliary drainage, utilizing an intravenously delivered cholecystokinin analogue, test, wherein if said combined endoscopic ultrasound and stimulated biliary drainage test is positive then said patient would be a good candidate for a cholecystectomy and if normal then go to step (h);

(h) conducting an endoscopic retrograde cholangiography test to determine whether any gallstones are present in the common bile duct, wherein if any gallstones are present then said patient would be a good candidate for a either an endoscopic sphincterotomy or a cholecystectomy and if no gallstones are present then go to step (i); and

(i) conducting a sphincter of oddi manometry test to determine if there is elevated sphincter of oddi basal pressure, wherein if there is at least 40 mm of mercury sphincter of oddi pressure then said patient would be a good candidate for an endoscopic sphincterotomy and if less than 40 mm of mercury then the candidate would be a good candidate for dietary and/or pharmaceutical therapy.

16. The method according to claim 15 wherein said combined endoscopic ultrasound and stimulated biliary drainage test comprises the following steps:

inserting an endoscopic ultrasound device within the antrum of a stomach;

positioning said endoscopic ultrasound device within said stomach such that said endoscopic ultrasound device is allowed to have a substantially unobstructed view of said gallbladder;

activating said endoscopic ultrasound device such that it is capable of detecting whether said gallbladder exhibits any of the following;

gallbladder sludge or small gallstones, focal wall thickening, or adhesions about said gallbladder and/or cystic duct;

delivering a cholecystokinin analogue intravenously to said human to enable said gallbladder to contract and to produce an ejection fraction of bile from said gallbladder during each contraction thereof;

determining the degree of contraction of said gallbladder by means of measuring each said ejection fraction of said gallbladder; and

removing said ejection fractions from said patient and analyzing said ejection fractions to detect the presence or absence of calcium bilirubinate and/or cholesterol granules or crystals therein.

17. The method according to claim 16 wherein said cholecystokinin analogue is sincalide.

18. The method according to claim 16 wherein said cholecystokinin analogue is administered in a dosage of about 0.02 to 0.04 micrograms per kilogram of weight of said patient.

19. The method according to claim 16 wherein said ejection fraction of said gallbladder is the percentage of the gallbladder volume or contents that is ejected from said gallbladder during each contraction.

20. The method according to claim 19 wherein said means of measuring each said ejection fraction of said gallbladder and thus determining the degree of contraction of said gallbladder is a microprocessor.

21. The method according to claim 16 wherein said endoscopic ultrasound device generates a transmitted ultrasonic signal which comes into contact with said gallbladder and then returns to said endoscopic ultrasound device as a received ultrasonic signal.

22. The method according to claim 21 wherein said endoscopic ultrasound device comprises a transducer which is capable of both transmitting and receiving ultrasonic signals.

23. The method according to claim 21 wherein said received ultrasonic signal is sent to a signal processor where it is convened to a digitized signal and then sent to a microprocessor.

24. The method according to claim 23 wherein said microprocessor is connected to a video monitor which displays a visual computerized image of said gallbladder, wherein said gallbladder sludge or small gallstones, focal wall thickening, or adhesions about said gallbladder and cystic duct can be detected.

25. The method according to claim 16 wherein said ejection fractions of said bile are removed from said gallbladder by means of an aspiration device disposed within the second portion of the duodenum.

26. The method according to claim 25 wherein the presence or absence of calcium bilirubinate and/or cholesterol granules or crystals contained within said removed bile is detected by means of an electronic or optical microscope.

27. The method according to claim 16 wherein said endoscopic ultrasound device within said stomach is positioned such that said endoscopic ultrasound device is allowed to have a substantially unobstructed view of said gallbladder by means of pressing a water filled balloon against the stomach wall.

28. The method according to claim 16 wherein cholecystitis or microlithiasis of a gallbladder in said patient is diagnosed if at least one of the following criteria classifications are observed:

(A) two major criteria, (B) one major and one minor criteria, and (C) three minor criteria, wherein said major criteria comprises;

the presence of sludge or small stones in said gallbladder, and the finding of calcium bilirubinate granules or cholesterol crystals in said bile, and wherein said minor criteria comprises;

gallbladder adhesions, cystic duct adhesions, decreased ejection fraction of the gallbladder of less than 35%, and focal gallbladder wall thickening of greater than 2 mm.

29. A method for diagnosing subtle cholecystitis or microlithiasis of a gallbladder in a patient which comprises the following steps:

inserting an endoscopic ultrasound device within the antrum of a stomach;

positioning said endoscopic ultrasound device within said stomach such that said endoscopic ultrasound device is allowed to have a substantially unobstructed view of said gallbladder;

activating said endoscopic ultrasound device such that it is capable of detecting whether said gallbladder exhibits any of the following;

gallbladder sludge or small gallstones, focal wall thickening, or adhesions about said gallbladder and/or cystic duct;

delivering magnesium sulfate intraluminally via said endoscopic ultrasound device to said patient in order to stimulate bile flow from said gallbladder by relaxing the biliary sphincter of oddi; and

removing gallbladder bile from said patient and analyzing said gallbladder bile to detect the presence or absence of calcium bilirubinate and/or cholesterol granules or crystals therein.

30. The method according to claim 29 wherein said gallbladder bile is removed by means of an aspiration device disposed within the second portion of the duodenum.

31. The method according to claim 29 wherein said magnesium sulfate is administered in a dosage of about 30 cc.

32. A method for diagnosing the cause of right upper quadrant abdominal pain in a patient having a gallbladder which is substantially intact comprises the following steps:

(a) conducting a transabdominal ultrasound test, wherein if said transabdominal ultrasound test is positive then the patient would be a good candidate for a cholecystectomy and if normal then go to step (b);

(b) conducting an oral cholecystography test to determined the concentrating ability of said gallbladder, wherein if said oral cholecystography test reveals a decreased concentrating ability then the patient would be a good candidate for a cholecystectomy and if normal then go to step (c);

(c) conducting a combined endoscopic ultrasound and stimulated biliary drainage, utilizing an intraluminally delivered magnesium sulfate, test if dietary and/or pharmaceutical therapy does not alleviate the right upper quadrant abdominal pain of said patient, wherein if said combined endoscopic ultrasound and stimulated biliary drainage test is positive then said patient would be a good candidate for a cholecystectomy and if normal then go to step (d);

(d) conducting an endoscopic retrograde cholangiography test to determine whether any gallstones are present in the common bile duct, wherein if any gallstones are present then said patient would be a good candidate for a either an endoscopic sphincterotomy or a cholecystectomy and if no gallstones are present then go to step (e); and

(e) conducting a sphincter of oddi manometry test to determine if there is elevated sphincter of oddi basal pressure, wherein if there is at least 40 mm of mercury sphincter of oddi pressure then said patient would be a good candidate for an endoscopic sphincterotomy and if less than 40 mm of mercury then the candidate would be a good candidate for dietary and/or pharmaceutical therapy.

33. The method according to claim 32 further comprising the steps of:

(f) conducting a liver function test, wherein if normal then go to step (a) and if said liver function test is suggestive of biliary stasis then go to step (g);

(g) conducting a combined endoscopic ultrasound and stimulated biliary drainage, utilizing an intraluminally delivered magnesium sulfate, test, wherein if said combined endoscopic ultrasound and stimulated biliary drainage test is positive then said patient would be a good candidate for a cholecystectomy and if normal then go to step (h);

(h) conducting an endoscopic retrograde cholangiography test to determine whether any gallstones are present in the common bile duct, wherein if any gallstones are present then said patient would be a good candidate for a either an endoscopic sphincterotomy or a cholecystectomy and if no gallstones are present then go to step (i); and

(i) conducting a sphincter of oddi manometry test to determine if there is elevated sphincter of oddi basal pressure, wherein if there is at least 40 mm of mercury sphincter of oddi pressure then said patient would be a good candidate for an endoscopic sphincterotomy and if less than 40 mm of mercury then the candidate would be a good candidate for dietary and/or pharmaceutical therapy.

34. The method according to claim 33 wherein said combined endoscopic ultrasound and stimulated biliary drainage test comprises the following steps:

inserting an endoscopic ultrasound device within the antrum of a stomach;

positioning said endoscopic ultrasound device within said stomach such that said endoscopic ultrasound device is allowed to have a substantially unobstructed view of said gallbladder;

activating said endoscopic ultrasound device such that it is capable of detecting whether said gallbladder exhibits any of the following;

gallbladder sludge or small gallstones, focal wall thickening, or adhesions about said gallbladder and/or cystic duct;

delivering magnesium sulfate intraluminally via said endoscopic ultrasound device to said patient in order to stimulate bile flow from said gallbladder by relaxing the biliary sphincter of oddi; and

removing gallbladder bile from said patient and analyzing said gallbladder bile to detect the presence or absence of calcium bilirubinate and/or cholesterol granules or crystals therein.

35. The method according to claim 34 wherein said gallbladder bile is removed from said gallbladder by means of an aspiration device disposed within the second portion of the duodenum.

36. The method according to claim 34 wherein said magnesium sulfate is administered in a dosage of about 30 cc.