Table 5.

Randomized Controlled Trials of the Outcomes of Endoscopic Sphincterotomy (ES), Open Surgical Duct Exploration (Surg.), and Laparoscopic Surgery (Lap.), 1980–2000.

Author Intervention Mean Age y (range or ±SD) Patients n Stone Clearance n (%)* Additional CBDI needed (ES or Surg.) n (%) Minor and Major Complications n (%) Mortality n (%) Length of Hospital Stay d (mean or mean range) Author Conclusions
Neoptolemos et al. (1987)9 ES 61 (20–83) 55 50/55 (91.0) 2/55 (2.8) 18/55 (32.7) 2/55 (3.6) 9 No support for ES for CBD stones
Surg. 59 (20–82) 59 54/59 (91.5) 0/59 (0.0) 13/59 (22.1) 1/59 (1.7) 11

Stain et al. (1991)38 ES 48.4 (31–78) 26 17/26 (65.4) 1/26 (3.1) 4/26 (15.4) 0.0 5 No support for ES for CBD stones
Surg. 42.4 (20–86) 26 16/17 (84.2) 1/17 (3.1) 8/26 (30.8) 0.0 6

Stiegmann et al. (1992)39 ES 46.3±21.7 16 5/7 (71.4) 2/7 (28.6) 0 (0.0) 0.0 11.0 No advantage to treating CBD stones with ES
Surg. 38.1±14.8 18 6/7 (85.7) Not given 3/18 (16.7) 0.0 9.2

Hammarström et al. (1995)40 ES 75.0 (56–85) 39 35/39 (89.7) 7/39 (17.9) 7/39 (17.9) 0.0 13 ES and Surg. for CBD stones are equally effective
Surg. 73.5 (56–85) 41 37/41 (90.2) 6/41 (14.6) 9/41 (22.0) 0.0 16

Kapoor et al. (1996)42 ES 42 (20–60) 13 11/13 (85) 2/13 (15) 5/13 (38.5) 0 (0.0) 10.6 No support for ES in low-risk patients with CBD
Surg. 46 (24–75) 16 13/15 (87) 2/15 (13) 5/16 (31.3) 0 (0.0) 11.3

Targarona et al. (1996)41 ES 79 50 NG 2/50 (4.0) 8/50 (16) 3/50 (6.0) 17 In elderly or high-risk patients, surgery is preferable to ES
Surg. 80 48 NG 1/48 (2.1) 11/48 (23) 2/48 (4.0) 22

Rhodes et al. (1998)44 ES 68 (28–84) 40 37/40 (92.5) 10/40 (25.0) 6/40 (15.0) 0 (0.0) 3.5 Lap. is as effective as ES in clearing CBD stones
Lap. 62 (24–83) 40 40/40 (100) 10/40 (25.0) 7/40 (17.5) 0 (0.0) 1

Suc et al. (1998)43 ES 66.8±17.5 97 64/80 (80.0) 28/97 (28.9) 11/97 (11.3) 3/97 (3.1) 15.3 High risk of added procedures after ES precludes its use for treating CBD stones
Surg. 66.7±18.1 105 75/81 (92.6) 8/105 (7.6) 13/105 (12.3) 1/105 (1.0) 17.5

Cuschieri et al. (1999)45 ES 18–89 136 82/98 (83.7) 16/98 (16.3) 17/133 (12.8) 2/136 (1.5) 9 Similar outcomes for ES and Lap., shorter hospital stay with Lap. ES to be confined to high-risk patients
Lap. 19–88 133 90/109 (82.6) 19/109 (17.4) 21/133 (15.8) 1/133 (0.8) 6

Total ES 472 301/358 (84.1) 70/472 (14.8) 73/472 (15.5) 10/472 (2.1) 3.5–17
Surg. 313 201/220 (91.4) 37/265 (14.0) 60/313 (19.2) 4/313 (1.3) 6–22
Lap. 173 130/149 (87.2) 29/149 (19.5) 28/173 (16.2) 1/173 (0.6) 1–6
* The denominators include the total number of patients entered into the trial, after excluding those with suspected but absent CBD stones.
† The denominators include the number of patients with available data.
‡ Median.

CBDI, common bile duct interventions; d, day(s); NG, not given; y, year(s).

RMMJ Rambam Maimonides Medical Journal Rambam Health Care Campus 2024 April; 15(2): e0007. ISSN: 2076-9172
Published online 2024 April 28. doi: 10.5041/RMMJ.10521