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Recruiting NCT05720338

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Phase III Interventional Cyst of Pancreas Pancreatectomy Pancreas Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 19 French Blake Drain.
Who it may be relevant to
Registry conditions: Cyst of Pancreas, Pancreatectomy, Pancreas Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Composite endpoint comparison [Time frame: Within 90 days of surgery]
  • Composite endpoint comparison [Time frame: Within 90 days of surgery]
  • Composite endpoint comparison [Time frame: Within 90 days of surgery]
  • Composite endpoint comparison [Time frame: Within 90 days of surgery]
Secondary outcome measures (9)
  • Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF [Time frame: 90-day post operative time point]
  • Quality of Life Score [Time frame: At day 14 postoperative]
  • Quality of Life Score [Time frame: At day 14 postoperative]
  • Quality of Life Score [Time frame: At day 14 postoperative]
  • Quality of Life Score [Time frame: At day 90 postoperative]
  • Quality of Life Score [Time frame: At day 90 postoperative]
  • Quality of Life Score [Time frame: At day 90 postoperative]
  • Hospital Length of Stay [Time frame: 90-day post operative time point]
  • Cost analysis for overall healthcare costs [Time frame: At day 90 postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland

Identifiers

NCT: NCT05720338 · CASE6222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗