Lumen Of Fallopian Tube Research Articles

The Prognostic Value of Tumor Cell Clusters in the Fallopian Tube Lumen in Stage I Endometrioid Carcinoma.

The aim of this study was to investigate the pathologic prognostic factors such as tumor cell clusters (TCCs) in the fallopian tube lumen, myometrial invasion patterns, and positive peritoneal cytology (PPC) in women with Stage I endometrial endometrioid carcinoma (EEC). From 2009 to 2020, consecutive patients with Stage I EEC who underwent hysterectomy and bilateral salpingectomy were included. The primary outcome was the recurrence-free survival (RFS) rate, and the clinicopathological factors affecting RFS were analyzed. A total of 765 patients were enrolled. Seventeen patients (2.2%) had TCC in the fallopian tube lumen, and 58 patients showed a microcystic elongated and fragmented pattern (7.6%). PPC was found in 19 patients (2.5%). The median follow-up period was 61.0 months (range: 2.0-149.7). The majority (88.6%) of patients had Stage IA EEC. The 5-year RFS and overall survival rates were 97.5% and 98.5%, respectively. In multivariate analysis for RFS, the significant prognostic factors were lymphovascular invasion (hazard ratio = 4.604; 95% CI: 1.387-15.288; P = 0.013) and grade (grade 2; hazard ratio = 4.949; 95% CI: 1.035-23.654; P = 0.045, and grade 3; hazard ratio = 5.469; 95% CI: 1.435-20.848; P = 0.013). Other pathologic factors including TCC in the fallopian tube lumen, myometrial invasion patterns, PPC, and hormonal status had no prognostic significance. TCC in the fallopian tube lumen, myometrial invasion pattern, PPC, and estrogen and progesterone receptor positivity were not significant prognostic factors in Stage I EEC. In contrast, lymphovascular invasion and grade were significant prognostic factors.

Volumetric sonographic depiction of the fallopian tube lumen for the early detection of tubal abnormalities: A work in progress

ObjectivesThe fallopian tube (FT) has emerged as an important imaging target in the detection of early ovarian cancer, which has remained an evasive challenge in the field of medicine. Recent understanding of ovarian cancer has identified the distal FT as the site of early tumorigenesis. Evaluation of the FT poses challenges due to the small size and variable anatomic position. This study outlines image acquisition and analysis techniques for volumetric depiction of the FT lumen. MethodsWomen with BRCA+ ​mutations undergoing risk reduction salpingo-ophorectomy were imaged using contrast-enhanced 3D transvaginal ultrasound (n ​= ​7). Sono-salpingography was conducted with intraluminal contrast instilled through the cervix for improved imaging of the FT lumen. Three-dimensional volumetric data was collected for qualitative and quantitative image analysis. Pathologic correlation was conducted using the Sectioning and Extensively Examining the Fimbriated End Protocol (SEE-FIM). ResultsStudy subjects underwent 3D imaging with trans-cervical FT lumen contrast enhancement at the time of our interim reporting. None of the subjects in our initial study had serous tubal intraepithelial carcinoma (STIC) lesions, however one had acute inflammation of the FT. The 3D quantitative image analysis demonstrated areas of luminal irregularity corresponding to the regions of inflammation on pathology. ConclusionsOur study shows promise in the detailed evaluation of the FT lumen for the detection of luminal abnormalities. We continue to optimize image acquisition and analysis techniques for the detection of STIC lesions as we enroll additional patients.

Case report: carcinosarcoma of the fallopian tube

Abstract Introduction/Objective Carcinosarcoma is a malignant biphasic tumor composed of carcinomatous and sarcomatous elements. Carcinosarcoma of the fallopian tube is an extremely rare malignancy with fewer than 100 cases reported in the literature. We report a rare case of carcinosarcoma arising from the right fallopian tube. Methods/Case Report A 72-year-old female presented with worsening vaginal discharge and abdominal cramps. Abdominal computed tomography detected a right adnexal mass. A torsed fallopian tube with a large mass was identified intraoperatively. Grossly, a 3.1 cm tan friable mass was seen protruding from the right fallopian tube lumen with numerous detached tumor fragments (9.4 cm in aggregate). Microscopically, the tumor was biphasic with a major mesenchymal component and minor epithelial component. A solid pattern of spindled and epithelioid cells with heterologous element of chondrosarcoma and a separate component with features of high-grade serous carcinoma in cribriform and solid sheets with slit-like spaces were seen. Both components showed marked nuclear atypia, pleomorphism, prominent nucleoli, and frequent mitoses. Both components were positive for p53, PAX-8, and beta- catenin immunohistochemistry, with a Ki-67 index of 80-90%. The sarcoma component was positive for p16, vimentin, and smooth muscle actin; the carcinoma component was positive for WT1, pan-cytokeratin, and cytokeratin 7. Pelvic washings were negative for malignancy. Metastases were not identified. Chemotherapy with paclitaxel and carboplatin was initiated with no recurrence identified 17 months after treatment. Results (if a Case Study enter NA) N/A Conclusion Proper identification and reporting of rare malignancies, such as this fallopian tube carcinosarcoma, with treatment and follow up, provide oncologists with the necessary information to advance treatment.

Natural Herbal Estrogen-Mimetics (Phytoestrogens) Promote the Differentiation of Fallopian Tube Epithelium into Multi-Ciliated Cells via Estrogen Receptor Beta.

Phytoestrogens are herbal polyphenolic compounds that exert various estrogen-like effects in animals and can be taken in easily from a foodstuff in daily life. The fallopian tube lumen, where transportation of the oocyte occurs, is lined with secretory cells and multi-ciliated epithelial cells. Recently, we showed that estrogen induces multi-ciliogenesis in the porcine fallopian tube epithelial cells (FTECs) through the activation of the estrogen receptor beta (ERβ) pathway and simultaneous inhibition of the Notch pathway. Thus, ingested phytoestrogens may induce FTEC ciliogenesis and thereby affect the fecundity. To address this issue, we added isoflavones (genistein, daidzein, or glycitin) and coumestan (coumestrol) to primary culture FTECs under air–liquid interface conditions and assessed the effects of each compound. All phytoestrogens except glycitin induced multi-ciliated cell differentiation, which followed Notch signal downregulation. On the contrary, the differentiation of secretory cells decreased slightly. Furthermore, genistein and daidzein had a slight effect on the proportion of proliferating cells exhibited by Ki67 expression. Ciliated-cell differentiation is inhibited by the ERβ antagonist, PHTPP. Thus, this study suggests that phytoestrogens can improve the fallopian tube epithelial sheet homeostasis by facilitating the genesis of multi-ciliated cells and this effect depends on the ERβ-mediated pathway.

Early Abdominal Ectopic Pregnancy Masquerading as a Missed Miscarriage

A 43-year-old lady, gravida 2 para 0, presented to our emergency department with complaints of vaginal bleeding and lower abdominal pain. Her urine pregnancy test was positive. She was unable to recall her last menstrual period. A trans-vaginal ultrasound revealed a pregnancy with a crown rump length of 47 mm corresponding to 11.4 weeks with no fetal heartbeat detected. She was diagnosed with a missed miscarriage and was sent for a second confirmatory scan. The repeat scan was concordant with the initial scan and she was counseled for an evacuation of uterus. Her serum beta human chorionic gonadotropin level was 45,195 IU/L and her hemoglobin level was 6.5 g/dL. She underwent an evacuation of uterus as planned, but the Hegar dilator was only able to be advanced to a cavity length of 6 cm with minimal products of conception obtained. A bedside ultrasound was performed and it showed that the Hegar dilator was in the uterine cavity but not in continuity with the gestational sac and fetus. The diagnosis of an ectopic pregnancy was made and the surgery was converted to a diagnostic laparoscopy. On entry into the abdominal cavity, there was frank hemoperitoneum with adhesions limiting access to the pelvis, therefore decision was made to convert to laparotomy. The findings at laparotomy revealed a large inflamed left tubo-ovarian complex with tubal rupture and expulsion of the entire fetus and placenta into the Pouch of Douglas (POD). The diagnosis of a secondary implantation of the ectopic pregnancy in the POD after tubal rupture was confirmed and we performed adhesiolysis and left salpingectomy. The patient recovered uneventfully and the final histology showed products of conception within the lumen of the left fallopian tube in keeping with ruptured tubal ectopic pregnancy. J Med Cases. 2020;11(6):169-173 doi: https://doi.org/10.14740/jmc3484

High-grade Pelvic Serous Carcinoma Within the Fallopian Tube Lumen: Real or Artifact?

Tumor cells are occasionally observed in the lumen in histologic sections of the fallopian tube from women with gynecologic cancer. There is some evidence that this finding may be important in endometrial cancer, but its significance is unknown in women with extrauterine pelvic serous carcinomas (tubo-ovarian high-grade serous carcinoma). Fallopian tube sections from 213 women with extrauterine pelvic serous carcinoma were reviewed, and luminal tumor cells were correlated with clinical and pathologic features. Intraluminal tumor cells were found in 84 patients (39%). The presence or absence of luminal tumor cells correlated significantly with serous tubal intraepithelial carcinoma (52% and 33%, respectively, P=0.004), tubal lymphatic invasion (32% and 12%, respectively, P=0.0002), and number of tube sections reviewed (6.6 and 4.9 for lumen-positive and lumen-negative cases, respectively, P=0.0056). There was no correlation with the presence of ascites, peritoneal cytopathologic findings, lymph node metastases, or FIGO stage. In the setting of pelvic serous carcinoma, a substantial portion of fallopian tube tissue is often distorted, fibrotic, and difficult to identify. Since the identification of luminal tumor cells, serous tubal intraepithelial carcinoma and tubal lymphatic invasion all depend on identification of fallopian tube tissue, these correlates with luminal tumor cells could be a result of a higher likelihood of their observation when tubal tissue can be more readily identified and may not necessarily reflect a biologically important phenomenon. It remains unclear whether and in what proportion this finding reflects an artifact of specimen handling.

Detection of endometrial cancer cells in the fallopian tube lumen is associated with adverse prognostic factors and reduced survival

ObjectiveStage is a critical determinant of prognosis and treatment for endometrial cancer (EC) patients. Women who have had a tubal ligation for sterilization have improved EC survival, secondary to lower stage at presentation, suggesting that transtubal spread may represent an important route of metastasis. We evaluated detection of intraluminal tumor cells (ILTCs) in relation to tumor characteristics and survival. MethodsOne pathologist retrospectively evaluated hematoxylin and eosin sections of routinely collected fallopian tubes for ILTCs from 295 EC patients, masked to outcome. We used logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations between demographic (age, race) and clinical [FIGO 2009 stage, lymphovascular space invasion (LVSI), histological subtype] characteristics and ILTCs. Cox regression was used to estimate hazard ratios (HRs) and 95% CIs for associations between ILTCs and recurrence-free survival (RFS) and EC-specific survival, overall and stratified by histological subtype or stage. ResultsIn univariable logistic regression models, age (55–64 vs. ≥65: OR = 3.41, 95% CI = 1.48–7.84), stage (stage IV vs. stage I OR = 14.58, 95% CI = 5.27–40.35), LVSI (OR = 2.93, 95% CI = 1.42–6.04), and histological subtype (serous vs. low-grade endometrioid OR = 3.21, 95% CI = 1.08–9.58), were associated with ILTCs. Only age and stage remained significantly associated with ILTCs in adjusted models. ILTCs were significantly associated with lower EC-specific survival among women with serous EC or stage I disease; however, adjustment for age, stage, and histology attenuated these associations. ConclusionOur findings suggest that ILTCs are associated with adverse EC prognostic features and reduced survival in cases of early stage or serous histology.

Mucosal Proliferations in Completely Examined Fallopian Tubes Accompanying Ovarian Low-grade Serous Tumors: Neoplastic Precursor Lesions or Normal Variants of Benign Mucosa?

Malignant transformation of the fallopian tube mucosa, followed by exfoliation of malignant cells onto ovarian and/or peritoneal surfaces, has been implicated as the origin of most pelvic high-grade serous carcinoma. Whether a parallel pathway exists for pelvic low-grade serous tumors [ovarian serous borderline tumor (SBT) and low-grade serous carcinoma (LGSC)] remains to be fully elucidated. The literature is challenging to interpret due to variation in the diagnostic criteria and terminology for cytologically low-grade proliferations of the fallopian tube mucosa, as well as variation in fallopian tube specimen sampling. Recently, a candidate fallopian tube precursor to ovarian SBT, so-called papillary tubal hyperplasia, was described in advanced stage patients. The current study was designed to identify fallopian tube mucosal proliferations unique to patients with low-grade serous ovarian tumors (serous cystadenoma, SBT, LGSC) and to determine if they may represent precursors to the ovarian tumors. Fallopian tubes were thinly sliced and entirely examined microscopically, including all of the fimbriated and nonfimbriated portions of the tubes, from patients with ovarian serous cystadenoma (35), SBT (61), and LGSC (11) and from a control population of patients with ovarian mucinous cystadenoma (28), mature cystic teratoma (18) or uterine leiomyoma (14). The slides of the fallopian tubes were examined in randomized order, without knowledge of the clinical history or findings in the ovaries or other organs. Alterations of the mucosa of the fallopian tube were classified as type 1: nonpapillary proliferation of cytologically bland tubal epithelium exhibiting crowding, stratification, and/or tufting without papillary fibrovascular cores or as type 2: papillary alterations consisting of a fibrovascular core lined by a cytologically bland layer of tubal epithelium. A third abnormality, type 3, consisted of detached intraluminal papillae, buds, or nests of epithelium that cytologically resembled the epithelial component of SBT or LGSC. Mucosal proliferations were identified in subsets of all populations, including the control populations. Overall, type 1 proliferations were in 28% to 61% of all patients and type 2 alterations in 4% to 16%. There was no statistically significant difference in the incidence of type 1 or type 2 proliferations between the class of ovarian serous tumors (benign, SBT, LGSC), between early and advanced stage SBT, or between patients with any ovarian serous tumor and the control population of nonserous diagnoses. Type 3 alterations were only identified in patients with advanced stage SBT/LGSC and not in any early stage SBT or cystadenoma. These findings suggest that type 3 alterations floating in the fallopian tube lumen represent exfoliation of tumor cells from ovarian and/or peritoneal origin. Our study did not identify a mucosal-based proliferation of the fallopian tubes that was specific to ovarian low-grade serous tumors. Cytologically bland mucosal proliferations appear to be common in fallopian tubes from patients of all ages and unrelated to ovarian tumorigenesis. A consensus on diagnostic criteria and terminology for these types of proliferations is needed, as well as further study into their etiology, including possible association with hormonal environment.

Preliminary Assessment of a Hysteroscopic Fallopian Tube Heat and Biomaterial Technology for Permanent Female Sterilization.

Recent failures in hysteroscopic female sterilization procedures have brought into question the implantation of non-resorbable metal devices into the fallopian tubes due to long-term risks such as migration, fragmentation, and tubal perforation. The goal of this study is to assess whether a porous, biodegradable implant can be deposited into the fallopian tube lumen with or without a local mild heat treatment to generate a safe and permanent fallopian tube occlusion/sterilization event. The technologies investigated included freeze-cast collagen-based scaffolds and magnetic nanoparticle (MNP) based scaffolds. In vitro assessment of iron oxide MNP-based scaffolds was performed to determine the absorption rate density (ARD); subsequent computational modeling quantified the thermal in vivo steady state temperature as a function of tubal radius for treatment planning. For collagen-based scaffolds, in vivo testing was performed to study the biocompatibility in a mouse flank model, followed by implantation into an in vivo anestrus feline uterine horn (animal model for the fallopian tube). Biological responses were studied histopathologically. Uterine horn patency was assessed via radiographic imaging. Preliminary studies suggest the MNP-impregnated scaffold and a safe, noninvasive AMF excitation field have potential to generate a sufficient focal fallopian tube thermal dose to create a fibrotic healing event and ultimately, permanent tubal occlusion.

STUDY OF TROPHOBLASTS AND HISTOLOGICAL CHANGES OF FALLOPIAN TUBE IN TUBAL PREGNANCY AND ANATOMICAL CONSIDERATIONS FOR ITS EARLY RUPTURE

Address for Correspondence: Dr Sowmya S, Department of anatomy, Bangalore Medical College & Research Institute, Bangalore-560002, Karnataka, India. Phone No.: +91 9482476545. E-Mail: drsowmyanandan@gmail.com Access this Article online Quick Response code Web site: *1 Assistant Professor, MD Anatomy, Department of Anatomy, Bangalore Medical College & Research Institute, Bangalore, India. 2 Professor, MBBS, MD, Department of Anatomy, Bangalore Medical College & Research Institute, Bangalore, India. 3 Associate Professor, MBBS, MD, Department of Anatomy, Bangalore Medical College & Research Institute, Bangalore, India. 4 MBBS, MD Anatomy, Post Graduate student, Department of Anatomy, Bangalore Medical College & Research Institute, Bangalore, India. Fertilisation takes place in the lumen of fallopian tube, from where, aided by the ciliated columnar epithelium of the tube, the fertilised ovum makes its way into uterine cavity and the implantation occurs. The passage of fertilised ovum into uterine cavity is delayed or obstructed by developmental, mechanical or other defects which lead to tubal gestation. The incidence varies from 1 in 300 to 1 in 150 pregnancies and it contributes significantly to the maternal mortality and morbidity. Early diagnosis and therapy has helped to reduce the maternal death due to ectopic pregnancy. However, study on histological changes of early ectopic pregnancy are rather scarce and therefore, the present study was conducted on 25 patients of ectopic pregnancy specimens observed for the mode and extent of invasion of chorionic villi, and the histological changes in wall of the fallopian tubes to evaluate the causes of early tubal rupture as well as estimation of gestational age by the study of chorionic villi.

Cinical study on eucleation of corpus luteum and methotrexate to prevent persistent ectopic pregnancy

Objective To study eucleation of corpus luteum and methotrexate to prevent persistent ectopic pregnancy. Methods 162 patients with ectopic pregnancy were randomly divided into two groups .82 cases were in treatment group: MTX was injected into the affected side fallopian tube lumen after laparoscopic salpingostomy and eucleation of corpus luteum was performed.80 cases were in control group:MTX was injected into the same way and eucleation of corpus luteum wasn't performed. Serum HCG was tested for 4 times before the operation one day , three days and the 7 days after operation respectively.Results There were 10 patients of PEP in this study. One patient in treatment group. 9 patients in control group .The difference was significant between treatment group and control group(P＜0.05) .Serum HCG in the two groups decended significantly in the first 24 hours after operation(P＜0.0l).There was significant difference between the two groups (P＞0.05).As for the descending of HCG in day 3 and 7, that of HCG was lower than control group ( P＜ 0.01 ). Conelusion This is an effective and safer method to prevent persistent ectopic pregnancy after eucleation of corpus luteum and methotrexate. Key words: Persistent ectopic pregnancy; Eucleation of corpus luteum; Methotrexate

Allelic loss at TP53 in metastatic human endometrial carcinomas

Loss of heterozygosity (LOH) is implicated in the initiation and progression of various human neoplasia, and is observed in both early or in advanced-stage human cancers. The current study was aimed at investigating the frequency of LOH TP53 in human endometrial carcinoma (EC) metastases. LOH was analyzed using 3 intragenic polymorphisms in 38 primary ECs and corresponding metastatic lesions. Allelic loss at intron 1 was detected in 14 out of 38 (37%) primary carcinomas and in 11 out of 38 (29%) metastatic lesions. LOH at intron 1 in primary and metastatic tumors was concomitantly noted in 8 out of 38 (21%) cases. LOH at intron 4 was seen in 46% (17 out of 37) primary ECs and in 35% (13 out of 37) metastatic lesions. LOH at intron 4 in primary tumor/metastasis was concomitantly demonstrated in 27% (10 out of 33) cases. Allelic loss at exon 4 was detected in 5 out of 33 (15%) primary ECs and in one out of 33 (3%) corresponding metastases. Coexistence of LOH TP53 in primary ECs with metastases at intron 1 and intron 4 was observed in three out of 33 (9%) cases. Correlation between allelic loss at intron 1 in primary ECs and corresponding metastases was found (R = 0.475, p = 0.003). Moreover, there was correlation between LOH at intron 1 in metastastic ECs and allelic imbalance at intron 4 in primary uterine tumors (R = 0.416, p = 0.01). There was a relationship between LOH at intron 4 in primary ECs and corresponding metastatic lesions (R = 0.457, p = 0.004). LOH TP53 at intron 4 correlated with the presence of the neoplasm in the uterine cervix (R = 0.319, p = 0.049), and with the non-endometrioid type of primary tumor (R = 0.371, p = 0.024). There was a significant correlation between exon 4 LOH and patient age (less or equal to 50 years and above this age; R = -0.375, p = 0.032). p53 overexpression was present in thirteen out of 38 (34%) cases, both in primary ECs and in metastatic lesions. Overexpression of p53 was higher in non-endometrioid ECs (three out of 5; 60%) than in endometrioid-type uterine tumors (ten out of 33; 30.3%; p = 0.315). p53 overexpression correlated with the presence of cancer in the lumen of fallopian tube(s) (R = 0.032, p = 0.046), and with allelic loss at intron 1 in primary ECs (R = 0.599, p = 0.0001). In conclusion, LOH occurs not only in primary uterine tumors but also in corresponding metastases, with the higher incidence being reported at intron 4 of the TP53. A significant link existed between LOH TP53 at intron 1 and p53 overexpression in primary ECs, but not in the corresponding metastatic lesions.

Computed tomographic confirmation of distally placed Essure∗ microinsert

To highlight the use of CT scan to confirm proper placement of the Essure microinsert tubal occlusion device. Case report. Community-based, outpatient setting. A 37-year-old woman (G2P2002) who desired permanent sterilization. The patient underwent hysteroscopic placement of Essure microinserts, which was complicated by inability to confirm intraluminal placement of the left implant by hysteroscopic visualization. A CT scan performed that day confirmed intraluminal placement and ruled out intraperitoneal placement of the insert. Confirmation of correct insert placement. A CT scan confirmed the placement of the Essure insert within the fallopian tube lumen and excluded perforation into the peritoneal cavity. Computed tomography is a reliable way to determine whether Essure microinserts are properly placed when this cannot be determined by hysteroscopic visualization. Follow-up hysterosalpingography continues to be required to confirm tissue ingrowth at 3 months' time.

A 12-Month Prospective Evaluation of Transcervical Sterilization Using Implantable Polymer Matrices

To evaluate placement efficacy and reliability of a an intratubal occlusion device for permanent contraception and to assess tolerability and overall satisfaction. Seven hundred seventy women with known parity were recruited to participate in a prospective, multicenter study. Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used. Inserts were placed bilaterally in the fallopian tube lumen. Subsequent bilateral occlusion was assessed with hysterosalpingography. Overall, bilateral placement success was achieved in 611 of 645 women (95%). Bilateral occlusion was confirmed in 570 of 645 (88.4%). The 1-year pregnancy prevention rate as derived with life-table methods was 98.9%. This transcervical sterilization system offers an effective contraceptive method, which was well tolerated and had a high satisfaction rate. III.

Transtubal Spread of Serous Adenocarcinoma of the Endometrium: An Underrecognized Mechanism of Metastasis

Most endometrial carcinomas metastasize by invading myometrial lymphatics and spreading to regional lymph nodes. However, uterine serous carcinomas (USCs) metastasize frequently to peritoneal surfaces even when only minimally invasive. This study examines the methods of spread and the role of retrograde transtubal spread. Eighty-seven USCs treated by hysterectomy were identified. Primary peritoneal cases and cases with significant ovarian involvement were excluded. Eighty (92%) cases were pure serous, and the remainder had at least 25% serous histology. Fifty-four of 87 (62%) had extrauterine spread at hysterectomy, most commonly to peritoneal surfaces and sometimes to the pelvic lymph nodes. Twenty-six of 54 (48%) cases had no lymphatic/vascular (LV) invasion and 18/54 (33%) had no myometrial invasion. Eleven of these 54 (20%) patients with metastases lacked both myometrial and LV invasion, and the metastases involved the peritoneal surface more often than the lymph nodes (p<0.001). Three of the 11 cases had tumor clusters in the fallopian tube lumen. Another 13 cases also had clusters of tumor within the fallopian tube lumen, and all 16 cases had peritoneal spread (p<0.001). Extrauterine spread correlated highly with LV invasion (p<0.001) but not with the presence or depth of myometrial invasion. Retrograde transtubal implantation as well LV invasion are two important mechanisms by which USC spreads; all cases with tumor clusters in the fallopian tube lumen had peritoneal spread. This explains the phenomenon whereby patients with serous carcinomas confined to the endometrium and lacking LV invasion have widespread metastases to the peritoneum.

Hysteroscopic sterilization: long-term safety and efficacy

Introduction: The goal of the study was to assess the long-term safety and efficacy of hysteroscopic sterilization.Materials and Methods: The Essure micro-insert (Conceptus Inc., San Carlos, CA) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Successful bilateral device placement was achieved in 643 (94%) women. After confirmation of tubal occlusion by hysterosalpingogram, they began relying on the micro-inserts for contraception. These women continue to be assessed at 1-, 2-, 3-, 4- and 5-year intervals.Results: As of December 16, 2004, 643 women contributed effectiveness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase II subjects and 42.5 months for women in the Pivotal trial. To date, there have been no long-term adverse events found by the investigators to be directly related to the micro-insert or placement procedure.Conclusion: These findings indicate that this nonincisional method of hysteroscopic sterilization can be performed without general anesthesia and has acceptable long-term safety and contraceptive efficacy. Introduction: The goal of the study was to assess the long-term safety and efficacy of hysteroscopic sterilization. Materials and Methods: The Essure micro-insert (Conceptus Inc., San Carlos, CA) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Successful bilateral device placement was achieved in 643 (94%) women. After confirmation of tubal occlusion by hysterosalpingogram, they began relying on the micro-inserts for contraception. These women continue to be assessed at 1-, 2-, 3-, 4- and 5-year intervals. Results: As of December 16, 2004, 643 women contributed effectiveness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase II subjects and 42.5 months for women in the Pivotal trial. To date, there have been no long-term adverse events found by the investigators to be directly related to the micro-insert or placement procedure. Conclusion: These findings indicate that this nonincisional method of hysteroscopic sterilization can be performed without general anesthesia and has acceptable long-term safety and contraceptive efficacy.

Fallopian Tube Occlusion with Use of a Small Intestine Submucosa Device: Evaluation in a Rabbit Model

The present study evaluates the short- and midterm efficacy of a small intestinal submucosa (SIS) device for fallopian tube occlusion in rabbits. In a pilot study, several SIS device designs were tested for positional stability (absence of migration). The design selected for further testing consisted of a center of spongy SIS surrounded by an SIS sheet and held together by a 0.006-inch wire helix with two barbs. It was delivered on the tip of a short coaxial 3-F/5-F catheter set. Using this design, bilateral transuterine fallopian tube occlusion was performed in eight New Zealand White rabbits. Follow-up consisted of plain radiography at 2 weeks and hysterosalpingography at 6 weeks (n = 4 animals; eight tubes), 12 weeks (n = 2 animals; four tubes), or 24 weeks (n = 2 animals; four tubes). Thereafter, the animals were killed and the fallopian tubes were harvested for histologic evaluation. A single device was placed successfully in each fallopian tube. Fifteen of 16 devices (94%) remained in place throughout follow-up. One device migrated into the vagina at 2-week follow-up. Hysterosalpingography of the 15 tubes with occluders in place showed occlusion in seven of seven (100%) at 6 weeks, three of four (75%) at 12 weeks, and two of four (50%) at 24 weeks. Histologic evaluation revealed luminal occlusion by reorganized SIS containing macrophages, fibrocytes, and scant foreign-body giant cells. Only a mild inflammatory reaction was observed around the tube. In the animals with recanalization at 12 and 24 weeks, new channels were found alongside the original still-occluded fallopian tube lumen. The original lumen of the fallopian tube was effectively occluded by the SIS occluder, which was remodeled within the fallopian tubes of rabbits. Partial peripheral recanalization was observed over time.

Multicenter feasibility study of a new coaxial falloposcopy system

We compared falloposcopy employing a new coaxial system with traditional laparoscopic chromotubation and hysterosalpingography in a prospective, multicenter clinical trial at five tertiary infertility centers. Based on findings at hysterosalpingography or laparoscopic chromotubation, the 16 women (22 tubes) in group 1 had a presumed diagnosis of proximal tubal obstruction, and the 4 (7 tubes) in group 2 had unexplained infertility. Cannulation was successfully achieved in 83.3% of tubes. In group 1, 85% (17/20) of visualized tubes were patent and 35% (7/20) were normal. In group 2,40% (2/5) of visualized tubes were abnormal. Management was changed in 52.4% of women as a result of falloposcopic findings. Falloposcopy with this new coaxial system allows improved visualization with less bulky and less traumatic instruments. The system provides valuable information regarding the fallopian tube lumen that correlates poorly with that obtained with more traditional techniques.

Falloposcopic classification and treatment of fallopian tube lumen disease

To devise a diagnostic classification and scoring system for tubal lumen disease based on falloposcopy and to evaluate it against tuboplasty procedures and pregnancy outcomes. Prospective study approved by the hospital Institutional Review Board. Academic tertiary infertility center. Seventy-five women with hysterosalpingographic and laparoscopic evidence of endotubal disease had 112 tubes available for falloposcopic evaluation. Diagnostic and operative falloposcopy was performed, when indicated, using aquadissection, flexible wire cannulation, or direct balloon tuboplasty. The endotubal lumens were considered to be falloposcopically normal in 52 tubes (46%), to contain mild to moderate disease in 33 (29%), and severe to obstructive disease in 27 (25%) cases. Within a year of the procedure, 6 of the 28 women (21%) in whom at least 1 tube was normal conceived, in 2 of 22 (9%) with mild to moderate disease, and in 0 of 16 (0%) with severe endotubal disease. Falloposcopy provides a visual means of scoring endotubal disease and may be intrinsically therapeutic for dislodging intraluminal debris and breaking down filmy adhesions in normal or minimally diseased tubes. The presence of severe disease remains resistant to the use of current endotuboplasty treatments as reflected by poor pregnancy outcome, and such women should be provided the option of microsurgical tubal repair or in vitro fertilization and embryo transfer procedures.

Salpingoscopic findings in women undergoing sterilization.

We report the results of a prospective study carried out to investigate the appearance of the Fallopian tube lumen in 30 apparently normal women with a normal reproductive career, patient Fallopian tubes and a normal pelvic appearance at laparoscopy. The salpingoscopic appearance of the ampulla and fimbria of both Fallopian tubes was normal in 20 women. Amongst the other 10 women there were intratubal adhesions (n = 2), fronds attached to mucosal folds (n = 4), irregular blood vessels in mucosal folds (n = 2), unusual mucosal folds (n = 3) and black 'spots' within mucosal folds (n = 3). In three women who underwent salpingoscopy during the preovulatory phase of the ovarian cycle, the mucosal fold edges appeared rounded and contained blood vessels with brightly reflective walls. Our findings suggest that there is variation in the endoscopic appearance of the tubal lumen in women with a normal reproductive career. Some of these findings may be perceived to be tubal pathology causing subfertility.