Drainage After Pancreatectomy for Post-Pancreatectomy Care

Overseen By Robert Simon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Pregnancy, Previous pancreatic surgery, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.

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 data supports the effectiveness of the treatment 19 French Blake Drain for post-pancreatectomy care?

The Blake drain has been studied for its effectiveness in managing pancreatic fistula (a leakage of pancreatic fluid) after pancreatic surgery, showing it can be beneficial compared to other types of drains. ^{1 2 3 4 5}

Is the use of Blake drains generally safe for humans after pancreatectomy?

The studies reviewed focus on the effectiveness and management of drains after pancreatectomy, but they do not provide specific safety data for the Blake drain itself. However, the use of drains, including Blake drains, is a common practice in surgeries like pancreatectomy, suggesting a general acceptance of their safety in clinical settings. ^{1 2 6 7 8}

How is the 19 French Blake Drain treatment different from other treatments for post-pancreatectomy care?

The 19 French Blake Drain is a specific type of surgical drain used after pancreas surgery to manage pancreatic fistulas (leaks from the pancreas). It is designed to be more effective in draining fluids compared to other types of drains, like the Duple drain, potentially reducing complications and improving recovery. ^{1 2 5 8 9}

Research Team

Robert Simon, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

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.

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• 19 French Blake Drain (Device)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

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 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]

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 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 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 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 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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Efficacy of a Blake drainR on pancreatic fistula after pancreaticoduodenectomy. [2008]

2. Japan pubmed.ncbi.nlm.nih.gov

Clinical impact of the sequentially-checked drain removal criteria on postoperative outcomes after pancreatectomy: a retrospective study. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Postoperative computed tomography findings predict re-drainage cases after early drain removal in pancreaticoduodenectomy. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Passive Versus Active Intra-Abdominal Drainage Following Pancreaticoduodenectomy: A Retrospective Study Using The American College of Surgeons NSQIP Database. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Drain Placement After Pancreatic Resection: Friend or Foe For Surgical Site Infections? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

What are the predictors that can help identify safe removal of drains following pancreatectomy? [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Results of a randomized controlled trial comparing closed-suction drains versus passive gravity drains after pancreatic resection. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Trends and Variations in Drain Use Following Pancreatoduodenectomy: Is Early Drain Removal Becoming More Common? [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Indicators of complications and drain removal after pancreatoduodenectomy. [2011]