RECRUITING

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

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Conditions

Cyst of PancreasPancreatectomyPancreas NeoplasmPancreatic neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-13
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05720338

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
  2. * Age ≥18 years
  3. * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  1. * Patients \< 18 years old
  2. * Patients who are pregnant
  3. * Patients with a history of previous pancreatic surgery
  4. * Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
  5. * Patients with prior cystogastrostomy procedure
  6. * Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture
  7. * Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
  8. * Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
  9. * Patients who undergo oversewing of the pancreatic transection margin
  10. * Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
  11. * Patients who are unable to provide informed consent

Contacts and Locations

Study Contact

Robert Simon, MD
CONTACT
1-866-223-8100
TaussigResearch@ccf.org

Principal Investigator

Robert Simon, MD
PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Robert Simon, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2023-04-13
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • Pancreatic neoplasm

Additional Relevant MeSH Terms

  • Cyst of Pancreas
  • Pancreatectomy
  • Pancreas Neoplasm