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Sentinel Lymph Node Mapping
Abstracts / Journal of Minimally Invasive Gynecology 23 (2016) S1–S252
Study
Study characteristics
Tan-Kim 2015
941 patients LSH or TLH with morcellation 2001-12
Candidate LMS prevalence
LMS Incremental LMS deaths in LMS deaths Hysterectomy Hysterectomy difference cases LH (0.72) in AH (0.59) deaths in LH deaths in AH (LH-AH)
1:314 (0.0032)
320
230
189
Raine-Bennett 34,728 hysterectomies for 2016 presumed fibroids 2006-2013
1:429 (0.0023)
230
166
136
Graebe 2015
1,361 laparoscopic hysterectomy with power morcellation
1:454 (0.0022)
220
158
130
Paul 2015
1,781 TLH with vaginal morcellation 2004-2014
1:594 (0.0017)
170
122
100
Rodriguez 2016
12,226 LSH for fibroids among US insurance claims 2002-2011
1:763 (0.0013)
130
94
77
Pritts 2015
Meta-analysis of 133 studies on 1:1961 (0.00051) hysterectomy or myomectomy, indication fibroid, 30,193 patients. Required histopathology to be explicitly reported, included studies where cancer not found 10,119 hysterectomies over 14 years 1:2023 (0.00049) at single institution
51
37
30
49
35
29
Kho 2016
S5
12 12 10 10 12 12 10 10 12 12 10 10 12 12 10 10 12 12 10 10 12 12 10 10
32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22)
21 15 13 19 10 4 2 8 8 2 0 6 2 -4 -6 0 -3 -9 -11 -5 -13 -19 -21 -15
12 12 10 10
32 (-20) 38 (-26) 38 (-28) 32 (-22)
-14 -20 -22 -16
Candidate hysterectomy death rates
*Siedhoff MT et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212(5):591.e1-8. Conclusion: Updated estimates of occult LMS during surgery for presumed fibroids published after the FDA statements on morcellation did not change the results of our original decision analysis, adding strength to the conclusion that minimally invasive surgery remains a safe option for patients with leiomyomata.
with the right parametria and vagina. Reconstruction included ileal substitution. The patient underwent chemotherapy post-operatively and is healthy 9 years after surgery. Neither case had blood transfusion, anastomotic leak or stenosis. Laparoscopic radical ureteral reconstruction after extensive resection for recurrent gynecologic cancer assists in early administration of adjuvant therapy. 12
11
Plenary 2 - Oncology (12:10 PM - 1:10 PM)
Plenary 2 - Oncology (12:10 PM - 1:10 PM) 1:00 PM – GROUP B
12:50 PM – GROUP B Radical Ureteral Reconstruction After Extensive Resection for Recurrent Gynecologic Cancer Andou M, Kannno K, Shirane A, Yanai S, Nakajima S. Gynecology, Kurashiki Medical Center, Kurashiki-shi, Okayama-ken, Japan We describe the potential of laparoscopic reconstructive surgery. Case one suffered recurrent cervical cancer, originally undergoing TLH for CIS but pathology revealed 1B OCC 3mmx8mm adenocarcinoma. The patient opted for laparoscopic intervention for right ureteral obstruction for recurrence at the right parametria and ovary. We performed radical parametrectomy and reconstruction- Boari flap and psoas hitch. The patient could quickly undergo chemo-radiation, the primary therapy. Case two had recurrence at the right parametria and vagina, discovered three years after hysterectomy for stage 1A endometrial cancer. As the ureter was near the recurrent tumor, we resected part of the bladder and lower ureter
Sentinel Lymph Node Mapping Magtibay P III, Magtibay P II, Wasson MN. Mayo Clinic Arizona, Phoenix, Arizona The sentinel lymph node is the first chain node that receives primary lymphatic flow from the organ of interest. If this node is negative for metastatic disease, then other lymph nodes in the lymphatic basin are expected to be negative. Ultrastaging of the sentinel lymph node can be used during staging of endometrial and cervical carcinomas. When compared to full lymphadenectomy, sentinel lymph node mapping and excision is associated with significantly lower blood loss, decreased surgical time, and reduced lymphedema without compromising oncologic outcomes. Sentinel lymph node mapping can be completed with cervical injection of either 1% methylene blue or combined indocyanine green and near-infrared fluorescence imaging. Intraoperatively, the retroperiteum is
S6
Abstracts / Journal of Minimally Invasive Gynecology 23 (2016) S1–S252
accessed and areolar tissue is separated. This allows lymphatic channels and the sentinel lymph node to be visualized. Monopolar energy, traction, and counter-traction are used to fully excise the sentinel lymph node. 13
Plenary 3 - Hysteroscopy, Endometrial Ablation and Sterilization (2:15 PM - 3:15 PM) 2:15 PM – GROUP A
Hysteroscopic Proximal Tubal Occlusion versus Laparoscopic Salpingectomy as Treatment for Hydrosalpinges Prior to IVF or ICSI: A RCT Emanuel MH,1 Dreyer K,2 Hompes PGA,2 Mijatovic V.2 1Ob/Gyn, Spaarne Gasthuis, Hoofddorp, NH, Netherlands; 2Ob/Gyn, VU Medical Center, Amsterdam, NH, Netherlands
Baseline Characteristics
Age (mean) Grade of adhesion (%) Mild moderate Severe Causative procedure (%) 1st trimester post partum
Intervention
Control
32.5
33.2
7 45 48
8 54 38
71 30
76 24
Study Objective: Does hysteroscopic proximal tubal occlusion by intratubal devices as treatment for hydrosalpinges result in comparable ongoing pregnancy rates following IVF/ICSI as compared to laparoscopic salpingectomy? Design: A two-centre, randomized controlled non-inferiority trial between October 2009 and December 2014. Randomization was based on a computer generated randomization list. The study was unblinded. Primary outcome was ongoing pregnancy rate, defined as a fetal heartbeat on ultrasound beyond 10 weeks gestation following one IVF/ICSI treatment (fresh and frozen thawed embryo transfers). Setting: The in- and outpatient treatment units of an academic and nonacademic training hospital. Patients: Women aged 18-41 years, with uni- or bilateral ultrasound visible hydrosalpinges who were scheduled for an IVF/ICSI treatment. A total of 85 women were included. Intervention: 42 Patients were randomized to hysteroscopic proximal occlusion by intratubal device placement (outpatient) and 43 patients to laparoscopic salpingectomy (inpatient). Measurements and Main Results: The ongoing pregnancy rates per patient according to the intention to treat principle were 11/42 (26.2%) after hysteroscopic proximal occlusion by intratubal devices (intervention group) versus 24/43 (55.8%) after laparoscopic salpingectomy (control group) (p= 0.008) (absolute difference 29.6%; 95% confidence interval (CI) 7.1 to 49.1, relative risk (RR) 0.47 95% CI 0.27 – 0.83, p=0.01). In the per protocol analysis the ongoing pregnancy rate per patient following hysteroscopic proximal occlusion by intratubal devices was 9/27 (33.3%) compared to 19/32 (59.4%) following laparoscopic salpingectomy (p=0.067) (absolute difference 36.1%; 95% CI -1.8 to 50.0, RR 0.56; 95% CI 0.31 to 1.03, p = 0.062). Conclusion: Hysteroscopic proximal tubal occlusion by intratubal devices is inferior to laparoscopic salpingectomy in the treatment of hydrosalpinges in women undergoing IVF/ICSI with respect to ongoing pregnancy rates. 14
Plenary 3 - Hysteroscopy, Endometrial Ablation and Sterilization (2:15 PM - 3:15 PM) 2:25 PM – GROUP A
Tertiary Prevention of Morbus Asherman: A Randomized Controlled Trial Hanstede M, Emanuel MH. Asherman Expertise Center, Spaarne Gasthuis, Hoofddorp, Noord Holland, Netherlands Study Objective: The challenge with Asherman’s disease is not the remove the adhesions but to prevent them from coming back. Our objective was to study whether exogenous hormone administration starting immediately after a successful hysteroscopic adhesiolysis, in patients with M. Asherman reduces the incidence of spontaneous recurrence of adhesions more then the endogen production of hormones. Design: Single blind randomized controlled trial. Setting: The study was performed in the Asherman Expertise Center, a referral and last resort center for women suffering from Asherman’s
disease. This is a department of the Spaarne Gasthuis a teaching hospital in Hoofddorp/Haarlem, that is affiliated to the Amsterdam Universities in the Netherlands. Patients: A total of 110 patients with M. Asherman who had a successful hysteroscopic adhesiolysis were randomized. Intervention: After succesfull adhesiolysis (using hysteroscopy with conventional instruments guided by fluoroscopy) an intra uterine shield was inserted in the uterine cavity in all patients. Women who were allocated to the intervention group received a scedule with estragen and norethisteron for 40 days post operation. Measurements and Main Results: A control hysteroscopy was performed by a blinded gynecologist 2-3 months after adhesiolysis in all patients. During the 12 months follow up women were asked to monitor their bloodloss by PBAC and any sign of recurrence of adhesion or reintervention was monitored. In the hormone group the percentage of recurrences was slightly lower (but not significant p=0.590) than in the patients that did not receive hormone treatment, respectively 43.6% and 50.0%.
Study
Study characteristics
Tan-Kim 2015
941 patients LSH or TLH with morcellation 2001-12
Candidate LMS prevalence
LMS Incremental LMS deaths in LMS deaths Hysterectomy Hysterectomy difference cases LH (0.72) in AH (0.59) deaths in LH deaths in AH (LH-AH)
1:314 (0.0032)
320
230
189
Raine-Bennett 34,728 hysterectomies for 2016 presumed fibroids 2006-2013
1:429 (0.0023)
230
166
136
Graebe 2015
1,361 laparoscopic hysterectomy with power morcellation
1:454 (0.0022)
220
158
130
Paul 2015
1,781 TLH with vaginal morcellation 2004-2014
1:594 (0.0017)
170
122
100
Rodriguez 2016
12,226 LSH for fibroids among US insurance claims 2002-2011
1:763 (0.0013)
130
94
77
Pritts 2015
Meta-analysis of 133 studies on 1:1961 (0.00051) hysterectomy or myomectomy, indication fibroid, 30,193 patients. Required histopathology to be explicitly reported, included studies where cancer not found 10,119 hysterectomies over 14 years 1:2023 (0.00049) at single institution
51
37
30
49
35
29
Kho 2016
S5
12 12 10 10 12 12 10 10 12 12 10 10 12 12 10 10 12 12 10 10 12 12 10 10
32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22) 32 (-20) 38 (-26) 38 (-28) 32 (-22)
21 15 13 19 10 4 2 8 8 2 0 6 2 -4 -6 0 -3 -9 -11 -5 -13 -19 -21 -15
12 12 10 10
32 (-20) 38 (-26) 38 (-28) 32 (-22)
-14 -20 -22 -16
Candidate hysterectomy death rates
*Siedhoff MT et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212(5):591.e1-8. Conclusion: Updated estimates of occult LMS during surgery for presumed fibroids published after the FDA statements on morcellation did not change the results of our original decision analysis, adding strength to the conclusion that minimally invasive surgery remains a safe option for patients with leiomyomata.
with the right parametria and vagina. Reconstruction included ileal substitution. The patient underwent chemotherapy post-operatively and is healthy 9 years after surgery. Neither case had blood transfusion, anastomotic leak or stenosis. Laparoscopic radical ureteral reconstruction after extensive resection for recurrent gynecologic cancer assists in early administration of adjuvant therapy. 12
11
Plenary 2 - Oncology (12:10 PM - 1:10 PM)
Plenary 2 - Oncology (12:10 PM - 1:10 PM) 1:00 PM – GROUP B
12:50 PM – GROUP B Radical Ureteral Reconstruction After Extensive Resection for Recurrent Gynecologic Cancer Andou M, Kannno K, Shirane A, Yanai S, Nakajima S. Gynecology, Kurashiki Medical Center, Kurashiki-shi, Okayama-ken, Japan We describe the potential of laparoscopic reconstructive surgery. Case one suffered recurrent cervical cancer, originally undergoing TLH for CIS but pathology revealed 1B OCC 3mmx8mm adenocarcinoma. The patient opted for laparoscopic intervention for right ureteral obstruction for recurrence at the right parametria and ovary. We performed radical parametrectomy and reconstruction- Boari flap and psoas hitch. The patient could quickly undergo chemo-radiation, the primary therapy. Case two had recurrence at the right parametria and vagina, discovered three years after hysterectomy for stage 1A endometrial cancer. As the ureter was near the recurrent tumor, we resected part of the bladder and lower ureter
Sentinel Lymph Node Mapping Magtibay P III, Magtibay P II, Wasson MN. Mayo Clinic Arizona, Phoenix, Arizona The sentinel lymph node is the first chain node that receives primary lymphatic flow from the organ of interest. If this node is negative for metastatic disease, then other lymph nodes in the lymphatic basin are expected to be negative. Ultrastaging of the sentinel lymph node can be used during staging of endometrial and cervical carcinomas. When compared to full lymphadenectomy, sentinel lymph node mapping and excision is associated with significantly lower blood loss, decreased surgical time, and reduced lymphedema without compromising oncologic outcomes. Sentinel lymph node mapping can be completed with cervical injection of either 1% methylene blue or combined indocyanine green and near-infrared fluorescence imaging. Intraoperatively, the retroperiteum is
S6
Abstracts / Journal of Minimally Invasive Gynecology 23 (2016) S1–S252
accessed and areolar tissue is separated. This allows lymphatic channels and the sentinel lymph node to be visualized. Monopolar energy, traction, and counter-traction are used to fully excise the sentinel lymph node. 13
Plenary 3 - Hysteroscopy, Endometrial Ablation and Sterilization (2:15 PM - 3:15 PM) 2:15 PM – GROUP A
Hysteroscopic Proximal Tubal Occlusion versus Laparoscopic Salpingectomy as Treatment for Hydrosalpinges Prior to IVF or ICSI: A RCT Emanuel MH,1 Dreyer K,2 Hompes PGA,2 Mijatovic V.2 1Ob/Gyn, Spaarne Gasthuis, Hoofddorp, NH, Netherlands; 2Ob/Gyn, VU Medical Center, Amsterdam, NH, Netherlands
Baseline Characteristics
Age (mean) Grade of adhesion (%) Mild moderate Severe Causative procedure (%) 1st trimester post partum
Intervention
Control
32.5
33.2
7 45 48
8 54 38
71 30
76 24
Study Objective: Does hysteroscopic proximal tubal occlusion by intratubal devices as treatment for hydrosalpinges result in comparable ongoing pregnancy rates following IVF/ICSI as compared to laparoscopic salpingectomy? Design: A two-centre, randomized controlled non-inferiority trial between October 2009 and December 2014. Randomization was based on a computer generated randomization list. The study was unblinded. Primary outcome was ongoing pregnancy rate, defined as a fetal heartbeat on ultrasound beyond 10 weeks gestation following one IVF/ICSI treatment (fresh and frozen thawed embryo transfers). Setting: The in- and outpatient treatment units of an academic and nonacademic training hospital. Patients: Women aged 18-41 years, with uni- or bilateral ultrasound visible hydrosalpinges who were scheduled for an IVF/ICSI treatment. A total of 85 women were included. Intervention: 42 Patients were randomized to hysteroscopic proximal occlusion by intratubal device placement (outpatient) and 43 patients to laparoscopic salpingectomy (inpatient). Measurements and Main Results: The ongoing pregnancy rates per patient according to the intention to treat principle were 11/42 (26.2%) after hysteroscopic proximal occlusion by intratubal devices (intervention group) versus 24/43 (55.8%) after laparoscopic salpingectomy (control group) (p= 0.008) (absolute difference 29.6%; 95% confidence interval (CI) 7.1 to 49.1, relative risk (RR) 0.47 95% CI 0.27 – 0.83, p=0.01). In the per protocol analysis the ongoing pregnancy rate per patient following hysteroscopic proximal occlusion by intratubal devices was 9/27 (33.3%) compared to 19/32 (59.4%) following laparoscopic salpingectomy (p=0.067) (absolute difference 36.1%; 95% CI -1.8 to 50.0, RR 0.56; 95% CI 0.31 to 1.03, p = 0.062). Conclusion: Hysteroscopic proximal tubal occlusion by intratubal devices is inferior to laparoscopic salpingectomy in the treatment of hydrosalpinges in women undergoing IVF/ICSI with respect to ongoing pregnancy rates. 14
Plenary 3 - Hysteroscopy, Endometrial Ablation and Sterilization (2:15 PM - 3:15 PM) 2:25 PM – GROUP A
Tertiary Prevention of Morbus Asherman: A Randomized Controlled Trial Hanstede M, Emanuel MH. Asherman Expertise Center, Spaarne Gasthuis, Hoofddorp, Noord Holland, Netherlands Study Objective: The challenge with Asherman’s disease is not the remove the adhesions but to prevent them from coming back. Our objective was to study whether exogenous hormone administration starting immediately after a successful hysteroscopic adhesiolysis, in patients with M. Asherman reduces the incidence of spontaneous recurrence of adhesions more then the endogen production of hormones. Design: Single blind randomized controlled trial. Setting: The study was performed in the Asherman Expertise Center, a referral and last resort center for women suffering from Asherman’s
disease. This is a department of the Spaarne Gasthuis a teaching hospital in Hoofddorp/Haarlem, that is affiliated to the Amsterdam Universities in the Netherlands. Patients: A total of 110 patients with M. Asherman who had a successful hysteroscopic adhesiolysis were randomized. Intervention: After succesfull adhesiolysis (using hysteroscopy with conventional instruments guided by fluoroscopy) an intra uterine shield was inserted in the uterine cavity in all patients. Women who were allocated to the intervention group received a scedule with estragen and norethisteron for 40 days post operation. Measurements and Main Results: A control hysteroscopy was performed by a blinded gynecologist 2-3 months after adhesiolysis in all patients. During the 12 months follow up women were asked to monitor their bloodloss by PBAC and any sign of recurrence of adhesion or reintervention was monitored. In the hormone group the percentage of recurrences was slightly lower (but not significant p=0.590) than in the patients that did not receive hormone treatment, respectively 43.6% and 50.0%.