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Nordic trial of nasogastric tube use after operations for cancer in the gullet

A randomized controlled trial: nasogastric-tube post-esophagectomy complications

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39935085
Enrollment
450
Registered
2021-12-09
Start date
2022-01-21
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasogastric tube decompression after resection for esophageal cancer with gastric conduit reconstruction Surgery

Interventions

Participants will be allocated to either the intervention or control group. Allocation provided by online randomization with stratification for center, sex, and neck anastomosis (y/n). Intervention: I

Sponsors

Uppsala University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed esophageal or GEJ cancer in locally advanced stages (cT1a N+ or cT1b-4a any N; M0) and considered technically resectable by the local tumor board 2. Age =18 years 3. Planned for esophagectomy with gastric conduit reconstruction 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. No resection performed (reason specified) 2. Alternative reconstruction method used (Roux-limb/colonic interponate) 3. Surgeon choosing to leave NG-tube (reason specified) 4. No ability to understand the study in terms of risk and benefits (including language difficulties)

Design outcomes

Primary

MeasureTime frame
Incidence of an anastomotic leak measured using CT scan with peroral contrast at 7 days and data accrual in an eCRF by 6 weeks post-surgery

Secondary

MeasureTime frame
1. Incidence of pneumonia measured using data accrual in an eCRF by 6 weeks post-surgery 2. Overall complications measured using data accrual in an eCRF by 6 weeks post-surgery 3. Length of stay measured using data accrual in an eCRF by 6 weeks post-surgery 4. Health-related quality of life measured using structured interviews at discharge and 6 weeks post-surgery 5. Survival measured using review of survival information in relevant linked registries at 5 years 6. C-reactive protein (CRP) level measured using data accrual of CRP levels in the first 7 postoperative days in an eCRF by 6 weeks post-surgery

Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026