Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01679483
Other study ID # FloSeal-LND
Secondary ID
Status Completed
Phase N/A
First received September 3, 2012
Last updated May 27, 2017
Start date September 2012
Est. completion date November 2015

Study information

Verified date May 2017
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube

- FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB

- Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection

- Patients with adequate bone marrow, renal and hepatic function:

WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal

- American Society of Anesthesiology Physical Status 0-1

- Performance status of ECOG 0-2

- Patient must be suitable candidates for surgery

- Patients who have signed an approved Informed Consent

Exclusion Criteria:

- Patients with a history of pelvic or abdominal radiotherapy;

- Patients who are pregnant

- Patients with contraindications to surgery;

- Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);

- Patient's compliance and geographic proximity that do not allow adequate follow-up.

- Patients who undergo only lymph node sampling

Study Design


Intervention

Drug:
FloSeal application
At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.

Locations

Country Name City State
Korea, Republic of Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Asan Medical Center Baxter Healthcare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of lymphocele an lymphatic ascites within 1 year after surgery
Secondary Time interval from surgery to removal of closed drain system with 2 weeks after surgery
Secondary Postoperative drain amount with 2 weeks after surgery
Secondary Postoperative hospital stay within 2 weeks after surgery
Secondary Postoperative bleeding incidence within 2 weeks after surgery
Secondary Postoperative complication incidence within 1 month after surgery
Secondary Quality of life within 1 year after surgery
Secondary 2-year disease free survival and overall survival 2 years after surgery
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2