Opportunistic Salpingectomy for Preventing Ovarian Cancer

Not yet recruiting at 2 trial locations
GH
Overseen ByGillian Hanley, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether removing the fallopian tubes (Bilateral Salpingectomy) during gallbladder surgery can help prevent ovarian cancer. This additional procedure could offer a safe and cost-effective way to reduce the risk of developing the most common and deadly type of ovarian cancer. The trial targets individuals with fallopian tubes undergoing gallbladder surgery, who have at least 24 hours between their surgeon consultation and the surgery, regardless of menopause status. Participants must be able to give informed consent and should not plan on becoming pregnant in the future. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new preventive strategies for ovarian cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that opportunistic salpingectomy is safe during laparoscopic cholecystectomy?

Research has shown that removing both fallopian tubes, a procedure called bilateral salpingectomy, is safe and generally well-tolerated. One study found that women who underwent this procedure did not experience significant negative effects on ovarian function. The surgery required only a few extra minutes, and no major complications were reported.

Another study confirmed the procedure's safety, noting no increased surgical risks for patients. The operation typically adds just a few minutes to the surgery time, and patients did not face longer recovery times or other negative effects. These findings suggest that bilateral salpingectomy is a safe option for those considering it as part of their treatment plan.12345

Why are researchers excited about this trial?

Researchers are excited about opportunistic salpingectomy as a preventative measure for ovarian cancer because it offers a novel approach to reducing cancer risk. Unlike traditional methods that typically involve monitoring or more invasive procedures like full oophorectomy, this technique involves the removal of the fallopian tubes (salpingectomy) during an unrelated surgery, such as a laparoscopic cholecystectomy. This method is minimally invasive and can be performed opportunistically during other routine surgeries, potentially offering a proactive and less disruptive option in preventing ovarian cancer. By targeting the fallopian tubes, where many ovarian cancers are believed to originate, this protocol could significantly reduce the risk with fewer side effects and less recovery time.

What evidence suggests that opportunistic salpingectomy is effective for preventing ovarian cancer?

Research has shown that removing the fallopian tubes, a procedure called bilateral salpingectomy, can greatly reduce the risk of ovarian cancer. Studies have found that this surgery can lower the risk by up to 80%. It is particularly effective in preventing high-grade serous carcinoma, the most common and deadly type of ovarian cancer. Evidence indicates that this method is both safe and cost-effective. In this trial, some participants will undergo opportunistic salpingectomy in addition to laparoscopic cholecystectomy, while others will receive only the standard laparoscopic cholecystectomy. Even for women with an average risk of ovarian cancer, salpingectomy offers significant protective benefits.23567

Who Is on the Research Team?

SC

Scott Cowie, MD

Principal Investigator

University of British Columbia

HS

Heather Stuart, MD

Principal Investigator

University of British Columbia

PS

Pablo Serrano, MD

Principal Investigator

McMaster University

GH

Gillian Hanley, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for women who are already scheduled to have their gallbladder removed by keyhole surgery (laparoscopic cholecystectomy) and may be interested in also having their fallopian tubes removed at the same time to help prevent ovarian cancer.

Inclusion Criteria

I am 35 years old or older.
I have fallopian tubes and am having gallbladder surgery more than 24 hours after my consult.
I am able to understand and sign consent forms.
See 1 more

Exclusion Criteria

I want to become pregnant in the future.
I have less than 24 hours between my surgeon visit and my surgery.
I have had my fallopian tube or ovary surgically removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preoperative Assessment

Participants undergo preoperative assessment to ensure readiness for surgery

1 week
1 visit (in-person)

Surgical Intervention

Participants undergo laparoscopic cholecystectomy with or without opportunistic salpingectomy

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for immediate postoperative complications and recovery

1-2 days
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of surgical site infection and readmission rates

30 days
1-2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Bilateral Salpingectomy
  • Laparoscopic Cholecystectomy

Trial Overview

The study is testing whether removing both fallopian tubes during gallbladder removal surgery is practical, safe, and cost-effective as a way to lower the risk of developing ovarian cancer. It compares outcomes with standard gallbladder removal alone.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Opportunistic salpingectomyExperimental Treatment2 Interventions
Group II: Laparoscopic cholecystectomy onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Canadian Cancer Society (CCS)

Collaborator

Trials
84
Recruited
42,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Citations

Salpingectomy for the Primary Prevention of Ovarian Cancer

Salpingectomy has been associated with ovarian cancer risk reduction of approximately 80%. Studies have demonstrated that salpingectomy was safe, cost-effective ...

Opportunistic Salpingectomy as a Strategy for Epithelial ...

In the Swedish study, women who underwent bilateral salpingectomy had a 65% reduction in the risk of ovarian cancer and women who underwent sterilization had a ...

Outcomes From Opportunistic Salpingectomy for Ovarian ...

This cohort study examines observed vs expected rates of ovarian cancer among individuals who have undergone opportunistic salpingectomy.

FIGO position statement on opportunistic salpingectomy as an ...

Studies show that bilateral salpingectomy (BS) significantly reduces ovarian cancer incidence even in average-risk women. Bilateral ...

Prophylactic salpingectomy as a preventative strategy for ...

Bilateral salpingectomy (BS) has been shown to reduce OC risk in cohort studies [12] reported a 45% reduction in risk assuming OS would prevent ...

Opportunistic salpingectomy for ovarian cancer prevention

They reported that bilateral salpingectomy reduced the risk for ovarian cancer by 42 % (OR = 0.58, 95 % CI 0.36, 0.95); however, their distribution of ovarian ...

Fallopian Tube Removal Not Linked to Ovarian Cancer ...

Despite a 45% decreased risk of ovarian cancer for bilateral salpingectomy compared with no surgery (HR, 0.55; 95% CI, 0.29-1.05; P = .07), this ...