Clinical trial · Interventional
"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures
Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of funding
Summary
Brief summary (as posted)
This trial evaluates whether testing of bile with nanopore sequencing results in earlier detection of bacteriobilia (bacteria in bile) that may lead to surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Usage of nanopore sequencing for detection of bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Pancreatic Neoplasm | Benign Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Pancreatic Neoplasm | Malignant Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Laboratory Procedure | Other | — | UNRESOLVED |
| Nanopore Sequencing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (biospecimen collection, routine testing)
- description
- Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Laboratory Procedure
- type
- EXPERIMENTAL
- label
- Arm II (biospecimen, nanopore sequencing, routine testing)
- description
- Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Laboratory Procedure
- Device: Nanopore Sequencing
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 18 year (yr) male (M) or female (F) * Undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent Exclusion Criteria: * Women who are pregnant * Patients who are institutionalized or incarcerated * Patients without the cognitive capacity to consent * Patients undergoing emergency pancreaticoduodenectomy or total pancreatectomy * Patients enrolled in similar clinical trials involving use of perioperative antibiotics
References
Publications (0)
Data not yet available