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NCT Number: NCT05720338

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Robert Simon, MD

CONTACT

About this study

Pancreatic resections are commonly performed across the United States, yet still represent one of the most morbid abdominal operations in the country, with postoperative mortality as high as 7.7%. Distal pancreatectomy (DP) represents one of the most common approaches to pancreatic resection and is typically used for tumors of the pancreatic body or tail. This operation is known to have a high historic morbidity, with reports of overall morbidity between 12-52%. Common complications include intraabdominal abscess and surgical site infection. Postoperative pancreatic fistula (POPF) represents the most common complication following partial pancreatic resection, with rates reported with rates as high as 30% in multiple large retrospective studies. Multiple strategies to prevent postoperative pancreatic leak following distal pancreatectomy have been studied. One of the outstanding questions that remains is regarding the need for routine intraperitoneal drainage following DP, particularly since the advent of reinforced staple technology. This study aims to determine if intraperitoneal drainage is necessary following DP. This study will compare groups using a composite endpoint of complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
  • Age ≥18 years
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Patients < 18 years old
  • Patients who are pregnant
  • Patients with a history of previous pancreatic surgery
  • Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
  • Patients with prior cystogastrostomy procedure
  • Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture
  • Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
  • Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
  • Patients who undergo oversewing of the pancreatic transection margin
  • Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
  • Patients who are unable to provide informed consent

Treatment and study plan

19 French Blake Drain

Device

19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin

Other names: Intraperitoneal drain

Primary outcomes

  1. Composite endpoint comparison

    Time frame: Within 90 days of surgery

    Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF

  2. Composite endpoint comparison

    Time frame: Within 90 days of surgery

    Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF

  3. Composite endpoint comparison

    Time frame: Within 90 days of surgery

    Comparison between groups using a composite endpoint of complications that includes Readmission

  4. Composite endpoint comparison

    Time frame: Within 90 days of surgery

    Comparison between groups using a composite endpoint of complications that includes presence of Organ Space Surgical Site Infection

Secondary outcomes

  1. Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF

    Time frame: 90-day post operative time point

    Rates of drainage based off of the Grade B Postoperative pancreatic fistula

  2. Quality of Life Score

    Time frame: At day 14 postoperative

    Post-operative Quality of Life score using the PROMIS-10 Global Health

  3. Quality of Life Score

    Time frame: At day 14 postoperative

    Post-operative Quality of Life score using the PROMIS-10 Physical Function

  4. Quality of Life Score

    Time frame: At day 14 postoperative

    Post-operative Quality of Life score using the original Drain Quality of Life scale

  5. Quality of Life Score

    Time frame: At day 90 postoperative

    Post-operative Quality of Life score using the PROMIS-10 Global Health

  6. Quality of Life Score

    Time frame: At day 90 postoperative

    Post-operative Quality of Life score using the PROMIS-10 Physical Function

  7. Quality of Life Score

    Time frame: At day 90 postoperative

    Post-operative Quality of Life score using the original Drain Quality of Life scale

  8. Hospital Length of Stay

    Time frame: 90-day post operative time point

    Measurement of the difference in Hospital Length-of-Stay based on intraperitoneal drainage after DP

  9. Cost analysis for overall healthcare costs

    Time frame: At day 90 postoperative

    Cost analysis for overall healthcare costs associated with both methods of postoperative care

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Simon, MD

CONTACT

[email protected]

1-866-223-8100

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 9, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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