Epidemiology and significance of surgical margins in the management of HPV-associated vulvar precancers (H-SIL) - analysis of own data.

OBJECTIVE: Epidemiology and evaluation of the importance of surgical margins in the treatment of vulvar H-SIL - analysis of own data. MATERIAL AND METHODS: The prospective study included women dia-gnosed with HPV-associated vulvar epithelial neoplasia from 10/2016 to 1/2022. A total of 65 women were included. After surgical treatment, the women were distributed to groups according to surgical margins and were followed-up at regular intervals. RESULTS: Seventeen women (26%) dia-gnosed with HPV-associated vulvar intraepithelial neoplasia were under 49 years, whereas 48 women (74%) were older than 49 years. Recurrence rates of HPV-associated precancers were 12.3%, 1.5% and 3.1% in excisions with positive margins up to 1mm peripheral margins and 1-3mm peripheral margins, respectively. The risk of recurrence when the lesion reaches the margin is statistically significant, compared to a healthy margin of 1-3mm. CONCLUSION: Keeping the minimal healthy margin (1-3mm) seems to be an acceptable risk of recurrence of HPV-associated vulvar intraepithelial neoplasia with positive cosmetic effect and minimal risk of disturbing the psychosexual functions of women. Long-term regular follow-up is necessary.

Hysterectomy with a general gynecologist vs gynecologic-oncologist in the setting of endometrial intraepithelial neoplasia: a cost-effectiveness analysis.

BACKGROUND: Standard treatment for patients with endometrial intraepithelial neoplasia (EIN) is a hysterectomy, which has a 43% risk of concomitant endometrial cancer on final pathology. General gynecologists and gynecologic-oncologists perform hysterectomies; however, patients who have a hysterectomy for EIN with a general gynecologist and are found to have cancer may require a second surgery by a gynecologic-oncologist to complete staging. There is ongoing discussion regarding whether patients with EIN should be provided the option to receive the initial hysterectomy with a gynecologic-oncologist. OBJECTIVE: This study aimed to better understand if patients with EIN should be initially referred to a gynecologic-oncologist for treatment. We examined the cost-effectiveness of hysterectomy by general gynecologists vs gynecologic-oncologists for patients with EIN. STUDY DESIGN: We created a decision-analytical model using TreeAge Pro software to compare outcomes between hysterectomies by general gynecologists and those by gynecologic-oncologists in patients with EIN. Our theoretical cohort contained 200,000 patients, an estimate of the number of individuals diagnosed with EIN each year in the United States. Outcomes included costs, quality-adjusted life years, primary lymph node dissection, secondary lymph node dissection, surgical site infection, and perioperative mortality. We assumed that surgical morbidity and mortality were the same under generalist and specialist care and applied costs of travel and lost work for those seeing a gynecologic-oncologist. We performed univariable sensitivity analyses and multivariable probabilistic sensitivity analysis to assess the model's robustness given the uncertainty of model inputs. RESULTS: In our theoretical cohort of 200,000 patients with EIN, hysterectomy with a gynecologic-oncologist was associated with a decrease of 10,811 second surgeries for lymph node dissection, 87 surgical site infections, and 9 perioperative mortalities. When hysterectomy was performed by a general gynecologist, 9 fewer patients had a lymph node dissection because of perioperative mortalities that occurred before lymph node dissection with a gynecologic-oncologist. Hysterectomy with a gynecologic-oncologist was the dominant, cost-effective strategy because it saved $116 million and increased quality-adjusted life years by 180. In our univariable analyses, hysterectomy with a gynecologic-oncologist was cost-saving and increased quality-adjusted life years over a wide range of probabilities and costs for lymph node dissection, surgical site infection, and perioperative mortality. However, hysterectomy with a gynecologic-oncologist was only a cost-effective and cost-saving strategy in just over 50% of multivariable simulations, demonstrating that there is significant uncertainty in the model's cost-effectiveness. CONCLUSION: In our model, hysterectomy with a gynecologic-oncologist for patients with EIN was associated with cost savings and increased quality-adjusted life years. Our study supports that patients undergoing hysterectomy for EIN at institutions using Mayo criteria to determine need for lymphadenectomy may benefit from surgery with a gynecologic-oncologist rather than a general gynecologist to reduce costs and adverse events associated with a second surgery.

Lymph node assessment at the time of hysterectomy has limited clinical utility for patients with pre-cancerous endometrial lesions.

OBJECTIVE: The objective of this study was to determine the proportion of patients with a pre-invasive endometrial lesion who meet Mayo criteria for lymph node dissection on final pathology to determine if the use of sentinel lymph node biopsy in patients with pre-invasive lesions would be warranted. METHODS: All women who underwent hysterectomy for a pre-invasive endometrial lesion (atypical hyperplasia or endometrial intra-epithelial neoplasia) between 2009 and 2019 were included for analysis. Relevant statistical tests were utilized to test the associations between patient, operative, and pathologic characteristics. RESULTS: 141 patients met inclusion criteria. 51 patients (36%) had a final diagnosis of cancer, the majority (96%) of which were Stage IA grade 1 endometrioid carcinomas. Seven patients (5%) met Mayo criteria on final pathology (one grade 3, seven size >2 cm, one >50% myoinvasive). Three of these seven patients had lymph nodes assessed of which 0% had metastases. Six of these patients had frozen section performed, and 2 met (33%) Mayo criteria intraoperatively. Of the seven patients in the overall cohort that had lymph node sampling, six had a final diagnosis of cancer and none had positive lymph nodes. Of the 51 patients with cancer, only 10 had cancer diagnosed using frozen section, and only two met intra-operative Mayo criteria. Age > 55 was predictive of meeting Mayo criteria on final pathology (p = 0.007). No patients experienced a cancer recurrence across a median follow up of 24.3 months. CONCLUSIONS: Atypical hyperplasia and endometrial intra-epithelial neoplasia portend low risk disease and universal nodal assessment is of limited value.

Breast Cancer Found Incidentally After Reduction Mammaplasty in Young Insured Women.

BACKGROUND: Reduction mammaplasty is a common operation performed for healthy women. The estimated incidence of breast cancer diagnosed at the time of reduction mammaplasty varies from 0.06 to 4.5%, and information on the care of these patients is limited. This study aimed to determine the incidence of breast cancer identified incidentally during reduction mammaplasty and to characterize preoperative imaging. METHODS: Women 18 years of age or older who underwent reduction mammaplasty from 2013 to 2015 were identified from the Truven Health MarketScan® Research Databases. Patients with prior breast cancer were excluded. Descriptive statistics were calculated for patient characteristics, incidental breast cancer, preoperative breast imaging, and postoperative treatment. RESULTS: Reduction mammaplasty was performed for 18,969 women with a mean age of 42.5 years. Of these patients, 186 (0.98%) were incidentally found to have breast cancer, with 134 (0.71%) having invasive breast cancer and 52 (0.27%) having carcinoma in situ. The patients with incidentally found cancer were older than the patients without cancer (50.8 vs. 42.5 years; p < 0.001). Overall, 58.2% of the patients had undergone mammography before reduction mammoplasty. The rates were higher (> 80%) for the patients older than 40 years. Preoperative mammography was performed for 76.3% of those with a diagnosis of breast cancer at time of reduction mammoplasty. CONCLUSIONS: Breast cancer diagnosed incidentally at the time of reduction mammaplasty is uncommon and often radiographically occult. The majority of women older than 50 years appropriately received preoperative mammography. These data can be used to manage patient expectations about the potential for the incidental diagnosis of breast cancer at reduction mammaplasty, even with a negative preoperative mammography.

Does intra-operative margin assessment improve margin status and re-excision rates? A population-based analysis of outcomes in breast-conserving surgery for ductal carcinoma in situ.

BACKGROUND AND OBJECTIVES: Using a 2 mm margin criteria, we evaluated the effect of intra-operative margin assessment on margin status and re-excisions following breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). METHODS: We identified patients undergoing BCS for DCIS from a prospective, population-based database. Multivariable logistic regression was used to determine the effect of specimen mammography, ultrasound and macroscopic assessment by a pathologist on margins and re-excision rates. RESULTS: In 588 patients, 52% (95% confidence interval [CI], 48%-56%) had positive margins (<2 mm), 39% (95% CI, 35%-43%) had a re-excision and 15% (95% CI, 12%-18%) had completion mastectomy. There were few re-excisions for margins ≥2 mm (2%). Adjusting for confounders, any margin assessment versus wire localization alone did not reduce positive margins (odds ratio [OR], 0.75; P = 0.202) or re-excisions (OR, 1.14; P = 0.564), however both outcomes varied by type of technique ( P < 0.001). Individually, only macroscopic assessment by pathologist reduced positive margins (OR, 0.54; P = 0.002) and re-excisions (OR, 0.61; P = 0.036). CONCLUSIONS: Despite adherence to a 2 mm margin criteria, re-excision rates remain high following BCS for DCIS, with 39% converted to mastectomy when re-excision is required. Intra-operative margin assessment does not appear to reduce re-excisions; in particular, surgeons should be aware of the limitations of specimen mammography for margin assessment in DCIS.

The Current Burden of Follow-up of Stage 1A1 Cervical Cancer.

OBJECTIVE: The aim of this study was to assess the current burden and consistency of stage 1A1 cervical cancer follow-up within Greater Glasgow and Clyde Health Board. METHODS: A retrospective review was undertaken of women diagnosed with and treated of, between 2007 and 2011, stage 1A1 cervical cancer in Greater Glasgow and Clyde Health Board. Data were collected on referral cytology, definitive method of treatment, posttreatment cytology, and rate of recurrence. Outcomes included rate of recurrence, abnormal cytology, and number of interventions during follow-up. RESULTS: Of the 78 women diagnosed with stage 1A1 cervical cancer, 43 had a LLETZ (large loop excision of the transformation zone) as definitive treatment. Ninety percent of stage 1A1 cervical cancers were diagnosed following abnormal screening cytology. Almost 86% of all cytology post-LLETZ were negative. Only 1 woman had a recurrence. No posthysterectomy vault smears were low-grade dyskaryosis or worse. CONCLUSIONS: There is a very low rate of abnormal cytology after LLETZ. Vault smears are of limited benefit in the management of women posthysterectomy for stage 1A1 cervical cancer.

Cost Effectiveness of the Oncotype DX DCIS Score for Guiding Treatment of Patients With Ductal Carcinoma In Situ.

Purpose The Oncotype DX DCIS Score short form (DCIS Score) estimates the risk of an ipsilateral breast event (IBE) in patients with ductal carcinoma in situ (DCIS) treated with breast-conserving surgery without adjuvant radiation therapy (RT). We determined the cost effectiveness of strategies using this test. Materials and Methods We developed a Markov model simulating 10-year outcomes for 60-year-old women eligible for the Eastern Cooperative Oncology Group E5194 study (cohort 1: low/intermediate-grade DCIS, ≤ 2.5 cm; cohort 2: high-grade DCIS, ≤ 1 cm) with each of five strategies: (1) no testing, no RT; (2) no testing, RT only for cohort 2; (3) no RT for low-grade DCIS, test for intermediate- and high-grade DCIS, RT for intermediate- or high-risk scores; (4) test all, RT for intermediate- or high-risk scores; and (5) no testing, RT for all. We used utilities and costs extracted from the literature and Medicare claims to determine incremental cost-effectiveness ratios and examined the number of women needed to irradiate per IBE prevented. Results No strategy using the DCIS Score was cost effective. The most cost-effective strategy (RT for none or RT for all) was sensitive to small differences between the utilities of receiving or not receiving RT and remaining without recurrence. The numbers needed to irradiate per IBE prevented were 10.5, 9.1, 7.5, and 13.1 for strategies 2 to 5, respectively, relative to strategy 1. Conclusion Strategies using the DCIS Score lowered the proportion of women undergoing RT per IBE prevented. However, no strategy incorporating the DCIS Score was cost effective. The cost effectiveness of RT was exquisitely utility sensitive, highlighting the importance of engaging patient preferences in this decision. Physicians should discuss trade-offs associated with omitting or adding adjuvant RT with each patient to maximize quality-of-life outcomes.

Psychometric properties of 3 patient-reported outcome measures for the assessment of shoulder disability after neck dissection.

BACKGROUND: Patient-reported outcome measures evaluating shoulder disability after neck dissection have not been sufficiently validated. We assessed the psychometric properties of the Shoulder Disability Questionnaire (SDQ), Neck Dissection Impairment Index (NDII), and the Shoulder Pain and Disability Index (SPADI) in patients after neck dissection. METHODS: One hundred seven patients completed the SDQ, NDII, and SPADI on 4 occasions over 6 months, and underwent physical examination. We assessed internal consistency, test-retest reliability, clinical and construct validity, and responsiveness to change. The possibility of combining the NDII and SPADI items into a single scale was explored by Rasch analysis. RESULTS: All questionnaires exhibited good reliability and validity. We were successful in fitting a Rasch model to the data. CONCLUSION: The results support the suitability of the SDQ, NDII, and the SPADI for use in neck dissection patients. Combining the SPADI and NDII in a single Rasch scale improves item difficulty distribution but reduces variability and discriminative ability.

Histopathologic assessment of depth of follicular invasion of squamous cell carcinoma (SCC) in situ (SCCis): Implications for treatment approach.

BACKGROUND: Squamous cell carcinoma in situ (SCCis) has been reported to involve the hair follicle epithelium. Deep follicular invasion is often cited as a cause of treatment failure. OBJECTIVE: We sought to define the frequency and the depth of hair follicle invasion by SCCis. METHODS: The study included both a retrospective review of intraoperative pathology specimens from 42 SCCis cases treated with Mohs micrographic surgery and a prospective evaluation of serially sectioned SCCis tissue from 12 additional patients. Pathology specimens were analyzed for follicular invasion of SCCis. RESULTS: SCCis invasion of the superficial hair follicle infundibulum was observed in 61.3% to 87.5% of cases in the 2 cohorts, whereas invasion of the isthmus and lower follicle was observed in only 8.3% to 12.5% of cases. In most tumors the depth of follicular invasion was comparable with the thickness of the surrounding epidermis. The maximum observed depth of follicular invasion was 0.82 mm. LIMITATIONS: The study was performed on a limited number of cases referred for surgery at a single institution. CONCLUSIONS: Although SCCis invasion of the upper hair follicle infundibulum is common, deep invasion below the level of the surrounding epidermis is rare. This may have implications for optimal therapy of this condition.

Barriers to immediate breast reconstruction in the Canadian universal health care system.

PURPOSE: To describe the population-based rates of immediate breast reconstruction (IBR) for all women undergoing mastectomy for treatment or prophylaxis of breast cancer in the past decade, and to evaluate geographic, institutional, and patient factors that influence use in the publically funded Canadian health care system. METHODS: This population-based retrospective cohort study used administrative data that included 28,176 women who underwent mastectomy (25,141 mastectomy alone and 3,035 IBR) between April 1, 2002, and March 31, 2012, in Ontario, Canada. We evaluated factors associated with IBR by using a multivariable logistic regression model with the generalized estimating equation approach. RESULTS: The population-based, age-adjusted IBR rate increased from 5.1 procedures to 8.7 in 100,000 adult women (43.7%; P < .001), and the increase was greatest for prophylactic mastectomy or therapeutic mastectomy for in situ breast cancer (78.6%; P < .001). Women who lived in neighborhoods with higher median income had significantly increased odds of IBR compared with mastectomy alone (odds ratio [OR], 1.71; 95% CI, 1.47 to 2.00), and immigrant women had significantly lower odds (OR, 0.59; 95% CI, 0.44 to 0.78). A patient had nearly twice the odds of receiving IBR when she was treated at a teaching hospital (OR, 1.84; 95% CI, 1.1 to 3.06) or at a hospital with two or more available plastic surgeons (OR, 2.01; 95% CI, 1.53 to 2.65). Patients who received IBR traveled significantly farther compared with those who received mastectomy alone (OR, 1.04; 95% CI, 1.02 to 1.05 for every 10 km increase). CONCLUSION: IBR is available to select patients with favorable clinical and demographic characteristics who travel farther to undergo surgery at teaching hospitals with two or more available plastic surgeons.

Newly diagnosed early breast cancer - an update on pre-operative assessment and staging.

BACKGROUND: Most breast cancer seen in developed nations is diagnosed at an early stage and surgery is the recommended first line treatment in most cases. OBJECTIVE: This article reviews the current approach and related evidence on pre-operative assessment of women with newly diagnosed breast cancer. It discusses the use of conventional assessment tools (mammography, ultrasound and needle biopsy) for staging the breast and axilla, the evidence relating to breast magnetic resonance imaging and the indications for staging investigations for distant metastatic disease. It highlights recent changes in practice, including areas of nonconsensus, and informs general practitioners on evolving issues in the pre-operative care of the newly diagnosed breast cancer patient. DISCUSSION: Once a breast cancer diagnosis has been established, appropriate pre-operative evaluation to assess the extent of disease (locally and sometimes systemically) helps guide surgical management and decisions on adjuvant therapy.

Mucocele-like lesions diagnosed on breast core biopsy: assessment of upgrade rate and need for surgical excision.

Mucocele-like lesion (MLL) is a rare mucinous lesion of the breast with highly variable upgrade rates to atypia or malignancy on excision. This spectrum of data has led to differing opinions on the need for surgical excision. We evaluated 50 core biopsy specimens diagnosed as having MLLs and correlated the findings with those of excision pathology. Thirty-eight patients underwent surgical excision and 29 were benign (76%), 4 had atypical ductal hyperplasia (11%), and 5 had ductal carcinoma in situ (13%), with an overall upgrade rate of 13%. However, the risk of upgrade was exclusively associated with the presence of atypia as seen on the needle core biopsy. All 22 MLLs without atypia had benign excisions, while 5 (31%) of the 16 patients with MLLs with atypia were upgraded to ductal carcinoma in situ on excision. No invasive carcinoma was identified. We believe it is reasonable that women with the core biopsy diagnosis of MLL without atypia and no associated mass be offered close clinical follow-up as an alternative to surgery.

Mohs micrographic surgery utilization in the Medicare population, 2009.

BACKGROUND: Mohs micrographic surgery (MMS) is the criterion standard treatment for high-risk skin cancers. Few data on current MMS Utilization are available. OBJECTIVE: To better understand current trends in MMS use in the Medicare population. METHODS AND MATERIALS: The 2009 Medicare Limited Data Set Standard Analytic File (LDSSAF), carrier claims, 5% sample and the Physician Supplier Procedure Master File (PSPMF) 100% summary were analyzed. RESULTS: In 2009, 558,447 Medicare MMS cases were performed, with an average of 1.75 stages per case. In the 5% claims sample, 0.3% and 1.3% of MMS cases were performed for melanoma and carcinoma in situ, respectively. Total annual volume predictions for 1,777 providers showed a left-shifted curve. 65.8% of LDSSAF cases had same-day MMS repairs: 48.7% of repairs were complex, 9.8% intermediate, 32.4% flaps, and 7.4% full-thickness skin grafts. CONCLUSIONS: The 5% LDSSAF is highly predictive of total claim volumes and is useful for modeling practice trends. There is wide variation in MMS provider annual case volume. These data reflect only Medicare Part B enrollees in 2009; 5% LDDSAF extrapolations are predictions based on sampling.

Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial.

BACKGROUND: Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. METHOD/DESIGN: This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. DISCUSSION: In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in reduced recurrence rates following surgical treatment of early-stage oral cancer with significant impacts on survival, morbidity, patients' quality of life and the cost to the health care system. TRIAL REGISTRATION: Clinicaltrials.gov NCT01039298.

Use of restaging bladder tumor resection for bladder cancer among Medicare beneficiaries.

OBJECTIVE: To evaluate the use and effectiveness of restaging bladder tumor resection using population-based data. Restaging bladder tumor resection improves staging accuracy and the response to intravesical therapy. However, its use outside of a tertiary care setting, and its subsequent clinical implications, are unknown. METHODS: We identified 62 016 patients diagnosed with bladder cancer between 1992 and 2005 using SEER-Medicare data. Restaging bladder tumor resection was defined as 2 or more resections occurring within 60 days of diagnosis. Using multivariable models, we assessed the relationship between the use of restaging resection and cancer-specific survival. RESULTS: Restaging resection was performed in only 3064 (4.9%) of newly diagnosed bladder cancer patients, but was most common among those with high grade (7.7% vs 2.0% in low grade, P < .001) and stage (8.8% in T2 vs 2.8% in Ta/Tis, P < .001) disease. Compared to patients with muscle-invasive cancers who did not undergo restaging at diagnosis, restaging resection was associated with improved 5-year cancer-specific mortality among pathologically staged patients (20.4% vs 28.0%, P = .02), while clinically staged patients trended toward improved mortality (28.2% vs 31.9%, P = .07). CONCLUSION: Restaging transurethral resection for bladder cancer is relatively uncommon and associated with improved survival among patients with muscle invasive bladder cancer. Greater use of restaging warrants further investigation as a simple means of improving outcomes among patients suspected of having muscle invasive disease.

Preoperative risk assessment among women undergoing bilateral prophylactic mastectomy for cancer risk reduction.

BACKGROUND: Cancer risk assessment is an important decision-making tool for women considering irreversible risk-reducing surgery. Our objective was to determine the prevalence of BRCA testing among women undergoing bilateral prophylactic mastectomy (BPM) and to review the characteristics of women who choose BPM within a metropolitan setting. METHODS: We retrospectively reviewed records of women who underwent BPM in the absence of cancer within 2 health care systems that included 5 metropolitan hospitals. Women with invasive carcinoma or ductal carcinoma in situ (DCIS) were excluded; neither lobular carcinoma in situ (LCIS) nor atypical hyperplasia (AH) were exclusion criteria. We collected demographic information and preoperative screening and risk assessment, BRCA testing, reconstruction, and associated cancer risk-reducing surgery data. We compared women who underwent BRCA testing to those not tested. RESULTS: From January 2002 to July 2009, a total of 71 BPMs were performed. Only 25 women (35.2%) had preoperative BRCA testing; 88% had a BRCA mutation. Compared with tested women, BRCA nontested women were significantly older (39.1 vs. 49.2 years, P < 0.001), had significantly more preoperative biopsies and mammograms and had fewer previous or simultaneous cancer risk-reducing surgery (oophorectomy). Among BRCA nontested women, common indications for BPM were family history of breast cancer (n = 21, 45.6%) or LCIS or AH (n = 16, 34.8%); 9 nontested women (19.6%) chose BPM based on exclusively on cancer-risk anxiety or personal preference. CONCLUSION: Most women who underwent BPM did not receive preoperative genetic testing. Further studies are needed to corroborate our findings in other geographic regions and practice settings.

Incidence, management, and outcome of incidental gallbladder carcinoma: analysis of the database of the Swiss association of laparoscopic and thoracoscopic surgery.

BACKGROUND: Little is known about the long-term survival of patients with incidental gallbladder carcinoma (IGBC). The role of radical resection for this disease is discussed controversially in the literature. We present the long-term survival and the results of re-resection versus simple cholecystectomy of the database of the Swiss Association for Laparoscopic and Thoracoscopic Surgery (SALTS) from 1994 to 2004. METHODS: Eighty-nine patients with histologically confirmed carcinoma of the gallbladder were identified out of 30,960 patients undergoing laparoscopic cholecystectomy. Sixty-nine patients were included in our study. Long-term survival by different T-stage and comparison of patients with extended resection versus simple cholecystectomy were calculated using the log-rank test. The time-to-event data are demonstrated by Kaplan-Meier curves. RESULTS: The overall incidence of IGBC in patients who underwent laparoscopic cholecystectomy was 0.28% (89 of 30,960). Fifty patients underwent simple cholecystectomy [n = 2: carcinoma in situ (CIS); n = 2: pT1a; n = 10: pT1b; n = 23: pT2; n = 8: pT3; n = 5: pT4], whereas extended resection was performed in 19 cases (n = 2: pT1b; n = 11: pT2; n = 6: pT3). The comparison of simple cholecystectomy versus extended re-resection of the gallbladder bed and regional lymph node resections showed a significant benefit in overall survival for the pT2 and pT3 group (p < 0.05). The pT1b group showed no significant benefit in overall survival (p = 0.34). CONCLUSION: IGBC has a low incidence (0.28%). We present a large study of patients with IGBC, comparing the overall survival by different histological findings. We observed a significant benefit for the group with pT2 and pT3. Therefore we recommend extended resection of the gallbladder bed and the regional lymph nodes for patient with incidental histologically confirmed pT2 and pT3 carcinoma of the gallbladder after performance of laparoscopic cholecystectomy. For patients with pT1b stage no recommendations can be given based on this study.