Effects of endoscopic sphincterotomy on biliary epithelium: A case-control study

Table 1 Demographic characteristics of the two groups n (%)

	First group	Second group (control)	P value
Patients	25	25
Sex, male/female	11/14	11/14	13
Median age (yr)	71 (range 49-89)	76 (range 44-94)	0.494
ERCP indication
Stent removal	4 (16)	-
Biliary colic	5 (20)	17 (68)	0.013
Biliary pancreatitis	1 (4)	2 (8)
Acute cholangitis	15 (60)	6 (24)
Previous biliary operation1	19 (76)	6 (24)	0.0013
Dilated bile ducts (ultrasound)	14 (56)	18 (72)	0.233
Median time from ES (mo)2	42 (range 8-144)	-

¹Previous biliary operations were laparoscopic or open cholecystectomies;

²This is the median time since prior endoscopic sphincterotomy (ES) that cytology brushing was performed;

³Estimated P values were calculated using the χ² test;

⁴Estimated P value was calculated using the Mann-Whitney test. ERCP: Endoscopic retrograde cholangiopancreatography.

Table 2 Diagnostic categories for cytologic diagnosis

Cytological grade	Definition
Unsatisfactory	No diagnostic specimen: acellular or hypocellular;
	Smears too thick, containing blood, obscured by inflammation or air-drying artefacts
Negative for malignancy	Adequate cellular specimens containing benign cells consistent with normal elements of the target organ
Atypical/indeterminate	Minimally abnormal cellular findings that most likely represent reactive/reparative and inflammatory type changes; Malignancy is unlikely but cannot be completely ruled out
Suspicious for malignancy	Cytologic specimens exhibit abnormal cellular findings that display some, but not all, of the features of malignancy; Specimens containing highly abnormal cells in very limited numbers
Positive for malignancy	Unquestionable cellular features of malignancy

Table 3 Comparative analysis of the two groups n (%)

	First group	Second group (control)	P value
Patients	25	25
Cytologic evaluation
Atypical	8 (32)	2 (8)	0.0342
Negative	17 (68)	23 (92)
Stone extraction on ERCP	13 (52)	16 (64)	0.392
Dilated bile ducts1 without lithiasis on ERCP	8 (32)	7 (28)	0.752
p53 immunocytology Positive	2	0

¹Diameter of the common bile duct > 10 mm;

²Estimated P values were calculated using the χ² test. ERCP: Endoscopic retrograde cholangiopancreatography.

Table 4 Subgroup analysis of the patients with atypia vs all others n (%)

	Atypical/indeterminate	Negative for malignancy	P value
Patients	10	40
Median age (yr)	69.5 (SD = 11.3)	74.5 (SD = 12.1)	0.262
Sex, male/female	3/7	20/20	0.251
Previous ES	8 (80)	17 (42)	0.0341
Acute cholangitis	5 (50)	16 (40)	0.561
Previous biliary operation	6 (60)	19 (47)	0.481
Stone extraction	5 (50)	22 (55)	0.771
Dilated bile ducts without lithiasis on ERCP	4 (40)	18 (45)	0.781
p53 immunocytology
Positive	2	0
Negative	8	40

¹Estimated P values were calculated using the χ² test;

²Estimated P value was calculated using the Mann-Whitney test. ES: Endoscopic sphincterotomy; ERCP: Endoscopic retrograde cholangiopancreatography.

Table 5 Patients with positive p53 immunocytology

	Sex	Age (yr)	Indication ERCP	Previous biliary operation	Stone extraction	Cytological evaluation	Time from ES (mo)	Negative1 follow-up
Patient 1	Female	49	Acute cholangitis	Yes (open cholecystectomy)	No	Atypia	18	3 yr 5 mo
Patient 2	Female	54	Stent removal	Yes (open cholecystectomy)	Yes	Atypia	25	3 yr 6 mo

¹No clinical or laboratory findings of bile duct malignancy. ES: Endoscopic sphincterotomy; ERCP: Endoscopic retrograde cholangiopancreatography.