Drainage After Pancreatectomy for Post-Pancreatectomy Care

Overseen By Robert Simon, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Pregnancy, Previous pancreatic surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

234 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the necessity of using a drain after a distal pancreatectomy, which involves removing part of the pancreas. Researchers aim to determine if omitting the drain is as safe as using it when new staple technology is employed during surgery. The study compares two groups: one using the standard 19 French Blake Drain and one without it. Ideal candidates are those scheduled for this specific pancreas surgery who can understand and sign a consent form. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking surgical advancements.

Do I need to stop my current medications for this trial?

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 intraperitoneal drainage is safe for post-pancreatectomy care?

Research shows that the 19 French Blake Drain is generally well-tolerated in patients undergoing surgery to remove part of the pancreas. Surgeons commonly use this type of drain in these procedures to manage complications. Although these surgeries can sometimes lead to issues like abdominal infections, the drain helps prevent such problems.

Past studies involving thousands of patients indicate that using drains in pancreatic surgeries is common and aims to reduce post-surgery complications. However, current research explores whether performing the surgery without a drain is equally safe. The study has reached a stage with substantial safety information, indicating the treatment has passed earlier safety tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of omitting the standard practice of using intraperitoneal drains after a pancreatectomy. Typically, a 19 French Blake Drain is placed near the surgical site to manage fluids and prevent complications. However, this trial investigates whether skipping this step could lead to similar or even improved recovery outcomes, potentially reducing discomfort and risk of infection associated with surgical drains. This could revolutionize post-surgical care by simplifying the recovery process for patients.

What evidence suggests that omitting intraperitoneal drainage could be effective for post-pancreatectomy care?

Research has shown that the Blake drain effectively manages pancreatic fistula, a leak of pancreatic fluid after surgery. This drain reduces complications such as abdominal pus pockets. Studies involving many patients suggest that drains can help control these issues after pancreas surgery, which often leads to complications. In this trial, one group of participants will receive the standard care with the Blake drain, known for reducing post-surgery problems, while researchers study the effects of omitting drains in another group. ^{1 2 3 4 5}

Who Is on the Research Team?

Robert Simon, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults who are scheduled to have a distal pancreatectomy, with or without removing the spleen. They must understand and sign consent. It's not for those under 18, pregnant, with previous pancreatic surgery or gastric alterations, failed prior endoscopic interventions due to strictures, certain hernias found before or during surgery, additional organ resections besides pancreas/spleen, if oversewing of the cut pancreas edge occurs, unsafe conditions without a drain present during surgery, or inability to consent.

Inclusion Criteria

Subjects must have the ability to understand and the willingness to sign a written informed consent document.

I am scheduled for surgery to remove part of my pancreas.

Exclusion Criteria

I have had a cystogastrostomy procedure before.

I am unable to understand and give consent for treatment.

My previous attempts to treat my esophageal condition with endoscopy or ultrasound were unsuccessful.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo distal pancreatectomy with or without intraperitoneal drainage

1 week

Inpatient hospital stay

Postoperative Monitoring

Participants are monitored for postoperative complications such as POPF, infection, and length of hospital stay

12 weeks

Regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 19 French Blake Drain

Trial Overview The study tests whether skipping routine intraperitoneal drainage after cutting out part of the pancreas (distal pancreatectomy) using reinforced staple technology is just as good as including it. The focus is on avoiding serious complications like fistulas in the pancreas post-surgery (POPF), needing hospital readmission or infections inside the belly space where organs are.

How Is the Trial Designed?

Group I: Standard of care Active Control 1 Intervention

Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.

Group II: Omitting Standard of Care Active Control 1 Intervention

No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.

19 French Blake Drain is already approved in United States, European Union for the following indications:

Approved in United States as 19 French Blake Drain for:

• General surgical drainage
• Postoperative fluid management

Approved in European Union as Blake Drain for:

• Surgical drainage
• Fluid management in postoperative care

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

In a study of 180 patients who underwent pancreaticoduodenectomy (PD) or distal pancreatectomy (DP), 9.4% developed postoperative fistulas, with a higher incidence in patients with soft pancreatic remnants.

Postoperative amylase levels were a significant predictor of fistula formation; patients with levels above 173 U/L on day three were 11.46 times more likely to develop a fistula, highlighting the importance of monitoring amylase levels for safe drain removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the predictors that can help identify safe removal of drains following pancreatectomy? Eguia, E., Hwalek, AE., Martin, B., et al.[2019]

In a study of 39,057 patients who underwent pancreatic resections, drain placement after distal pancreatectomy was linked to a higher rate of organ/space surgical site infections (SSI), suggesting that drains may not be beneficial in this context.

Early removal of drains (before postoperative day 3) was associated with a lower rate of SSI across all types of pancreatectomy, indicating that minimizing the duration of drain placement could enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drain Placement After Pancreatic Resection: Friend or Foe For Surgical Site Infections? Pollini, T., Wong, P., Kone, LB., et al.[2023]

In a study of 14,356 patients who underwent pancreatoduodenectomy, early drain removal (EDR) within 3 days post-operation was performed in 16.2% of cases, with its use increasing by 68% from 2014 to 2020.

EDR was linked to significantly lower rates of overall complications, including serious morbidity and readmissions, suggesting it is a safe and effective practice, yet only a small fraction of patients received this management despite its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and Variations in Drain Use Following Pancreatoduodenectomy: Is Early Drain Removal Becoming More Common? Sahara, K., Ruff, SM., Miyake, K., et al.[2023]

In a study of 33 patients with pancreatic fistulas, those using Blake drains experienced significantly better outcomes, with all patients healing through conservative treatment and no need for further procedures, compared to those with Duple drains.

The basic experiment showed that Blake drains effectively prevent fluid collections and promote the formation of 'drain canals,' which help manage pancreatic fistulas without leading to complications like abdominal abscesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Blake drainR on pancreatic fistula after pancreaticoduodenectomy. Aimoto, T., Uchida, E., Nakamura, Y., et al.[2008]

In a study of 801 patients who underwent pancreatectomy, using sequentially-checked drain removal criteria led to a higher percentage of patients meeting safe removal criteria (76.1% vs. 63.8% with conventional criteria), indicating improved management of postoperative drains.

The sequentially-checked criteria significantly reduced the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) and intra-abdominal abscesses, suggesting that this method enhances patient safety and outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of the sequentially-checked drain removal criteria on postoperative outcomes after pancreatectomy: a retrospective study. Kosaka, H., Satoi, S., Yamamoto, T., et al.[2020]

In a study of 114 patients who had early drain removal after pancreaticoduodenectomy, 13% required re-drainage due to postoperative pancreatic fistula, highlighting a significant risk associated with early drain removal.

The study identified two key risk factors for re-drainage: a peri-pancreaticojejunostomic fluid collection (PFC) index of 8.16 cm³ or greater and a pancreatic cross-sectional area (CSA) of 3.65 cm² or greater, suggesting that careful assessment of these factors is crucial before deciding on early drain removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative computed tomography findings predict re-drainage cases after early drain removal in pancreaticoduodenectomy. Nitta, N., Maehira, H., Ishikawa, H., et al.[2023]

In a study involving 223 patients who underwent pancreatic resection, neither closed-suction drains nor passive gravity drains significantly affected the rate of postoperative pancreatic fistulae or overall complications, indicating both types of drains are similarly safe.

While both drain types had comparable outcomes, passive gravity drains produced less fluid in the early postoperative days but were more prone to obstruction, whereas closed-suction drains maintained their patency longer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a randomized controlled trial comparing closed-suction drains versus passive gravity drains after pancreatic resection. Čečka, F., Jon, B., Skalický, P., et al.[2019]

In a study of 151 patients who underwent pancreatoduodenectomy, those with severe intra-abdominal complications showed re-elevation of drain amylase levels after day 3 and prolonged inflammatory responses, indicating these factors are critical for monitoring post-surgery.

Patients with a consistent decline in drain amylase levels and shorter inflammatory responses could safely have their drains removed, even if amylase levels were elevated, suggesting that monitoring these trends can help determine the right timing for drain removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indicators of complications and drain removal after pancreatoduodenectomy. Kurahara, H., Shinchi, H., Maemura, K., et al.[2011]

In a study of 3430 patients undergoing pancreaticoduodenectomy, the type of drainage system (passive gravity vs. active suction) did not significantly affect the rates of postoperative pancreatic fistula or other major complications.

Active suction drainage was found to reduce the need for percutaneous drain insertion, but it was associated with a higher risk of superficial surgical site infections, suggesting a potential trade-off in choosing the drainage method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passive Versus Active Intra-Abdominal Drainage Following Pancreaticoduodenectomy: A Retrospective Study Using The American College of Surgeons NSQIP Database. Lemke, M., Park, L., Balaa, FK., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05720338

Is Intraperitoneal Drainage Necessary Following Distal ... This operation is known to have a high historic morbidity, with reports of overall morbidity between 12-52%. Common complications include intraabdominal abscess ...

2. withpower.com withpower.com/trial/phase-3-pancreatic-neoplasms-6-2023-69d73

Drainage After Pancreatectomy for Post- ... The Blake drain has been studied for its effectiveness in managing pancreatic fistula (a leakage of pancreatic fluid) after pancreatic surgery, showing it can ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/391399

Is Intraperitoneal Drainage Necessary Following Distal ... The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05720338/is-intraperitoneal-drainage-necessary-following-distal-pancreatectomy

Is Intraperitoneal Drainage Necessary Following Distal ... The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4616221/

Intra-abdominal drainage following pancreatic resection RESULTS: A total of 19 studies concerned with drain management in pancreatic surgery involving 4194 patients were selected for this systematic ...