Clinical Trial: Tachosil for the Prevention of Symptomatic Lymph Cysts

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Symptomatic Lymphoceles After Pelvic Lymphadenectomy in Women With Gynecologic Malignancies: a Randomized Cl

Brief Summary: This is a randomized trial of 140 women with endometrial or cervical cancer undergoing removal of lymph tissue (lymphadenectomy). The application of 4 tachosil fibrin patches to the pelvic side wall after tissue removal is tested against no such intervention after tissue removal. The primary endpoint is to evaluate the incidence of symptomatic pelvic lymphoceles defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. The study's hypothesis is that the application of tachosil fibrin patches will significantly reduce the rate of symptomatic lymph cysts.

Detailed Summary:

1. Background Women with gynecologic malignancies such as cervical and endometrial cancer routinely undergo pelvic lymphadenectomy based on tumor characteristics assessed prior to or during surgery. Pelvic lymphadenectomy may be performed by open surgery or laparoscopy (1-4). Postoperative complications during and after pelvic lymphadenectomy include local abscess, bleeding, lymphocele, and chronic lymphedema of the lower extremities, which has an incidence of 1 to 2% (2,3). In the present trial, we will focus on pelvic lymphoceles, one of the most common complications of pelvic lymphadenectomy. Simonato et al. described a rate of 19/30 (63%) of sonographically detected lymphoceles in men undergoing pelvic extraperitoneal lymphadenectomy for prostate cancer (4). In this trial, 4/19 men with lymphoceles were symptomatic and required medical interventions. In women with cervical cancer, asymptomatic lymphoceles detected by ultrasound have been noted in up to 11% of women after pelvic lymphadenectomy (1,3,5). In 2% of women, clinical symptoms will require a therapeutic intervention (5).

Tachosil® is a fibrin-collagen coated patch and heas been licensed in 2004 and 2007 in Europe for surgical use in humans to support surgical hemostatic interventions. The efficacy and safety of Tachosil® has been demonstrated in liver resection, pulmonary lobectomy, and kidney tumor resection trials (6-8). In men, but not in women, it has been demonstrated that the application of a collagen-fibrin patch to the lymphadenectomy surgery site may prevent a significant proportion of lymphoceles. In a randomized trial, Simonato et al. found that the pelvic application of two Tachosil® patches to the obturator fossa and the femoral canal was sufficient to significantly reduce the rate of sonographically detected lymphoceles within 4 weeks after surgery from 19/30 to 5/30 cases (p=0.00
Sponsor: Ruhr University of Bochum

Current Primary Outcome: symptomatic lymph cysts [ Time Frame: 4 weeks ]

Primary outcome variable:

2.1. To evaluate the incidence of symptomatic pelvic lymphoceles defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery.



Original Primary Outcome: lymph cysts [ Time Frame: 4 weeks ]

Primary outcome variable:

2.1. To evaluate the incidence of sonographically detected pelvic lymphoceles of at least 2cm in the largest diameter within 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery.



Current Secondary Outcome: asymptomatic lymph cysts, intervention rate due to symptomatic lymph cysts [ Time Frame: 4 weeks ]

Secondary outcome variables:

2.2. To evaluate the incidence of sonographically detected pelvic lymphoceles of at least 2cm in the largest diameter 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery.

2.3. To evaluate the rate and type of medical interventions for clinically symptomatic pelvic lymphoceles such as analgesics and/or lymphocele puncture and drainage.



Original Secondary Outcome: symptomatic lymph cysts, intervention rate due to symptomatic lymph cysts [ Time Frame: 4 weeks ]

  1. Incidence of clinically symptomatic pelvic lymphoceles, ie localized pelvic pain in the presence of a sonographically verified pelvic lymphocele of at least 2cm in the largest diameter, within 4 weeks after surgery.
  2. Number of patients undergoing lymphocele puncture with or without drainage within 4 weeks after surgery
  3. Number of patients undergoing repeat surgery for lymphocele removal within 4 weeks after surgery.


Information By: Ruhr University of Bochum

Dates:
Date Received: July 12, 2011
Date Started: November 2011
Date Completion:
Last Updated: January 19, 2016
Last Verified: January 2016