Nordic trial of nasogastric tube use after operations for cancer in the gullet
| ISRCTN | ISRCTN39935085 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39935085 |
- Submission date
- 08/12/2021
- Registration date
- 09/12/2021
- Last edited
- 13/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The mainstay of curative treatment of cancer in the esophagus (gullet) is surgical resection with a part of the stomach used for replacement of the resected esophagus. In Scandinavia, a naso-gastric tube (NG tube) is generally left in place after surgery but the clinical benefits and potential harms of this practice are unclear and because esophageal surgery is laden with feared complications, especially leak on the connection between the stomach remnant and the esophagus (anastomotic leak), many surgeons are reluctant to abandon old routines. We hypothesized that abstaining from NG-tube use is non-inferior to using NG-tube after esophagectomy regarding anastomotic leak and overall complications.
Who can participate?
Adult patients undergoing esophagectomy for cancer in Scandinavia
What does the study involve?
Patients will be randomly allocated to one of two groups, with an equal chance of being in either group (like tossing a coin), to either have a nasogastric tube kept in place after surgery or have this tube removed immediately after surgery.
What are the possible benefits and risks of participating?
The potential benefits of participation are less postoperative discomfort for patients not having an NG tube, but also possibly fewer complications. The potential risks are a slightly higher complication rate.
Where is the study run from?
Uppsala University (Sweden)
When is the study starting and how long is it expected to run for?
From July 2020 to December 2030
Who is funding the study?
Swedish Cancer Foundation (Sweden)
Who is the main contact?
Dr Jakob Hedberg, jakob.hedberg@surgsci.uu.se
Contact information
Scientific
Department of Surgical Sciences
Uppsala University Hospital
Uppsala
75185
Sweden
 ORCID ID |
0000-0003-1308-4592 |
|---|---|
| Phone | +46 703785973 |
| jakob.hedberg@surgsci.uu.se |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A randomized controlled trial: nasogastric-tube post-esophagectomy complications |
| Study acronym | Kinetic |
| Study objectives | Omitting the use of nasogastric tube after resection for esophageal cancer with a gastric conduit, is non-inferior to currant practice (postoperative nasogastric tube decompression) |
| Ethics approval(s) | 1. Approved 12/10/2021, Etikprövningsmyndighetens (Box 2110, 75002 Uppsala, Sweden; +46 (0)10-475 0800; registrator@etikprovning.se), ref: 2021-03761 2. Approved 21/07/2021, REK sør-øst B (Gullhaugveien 1-3, 0484 Oslo, Norway; +4722 84 55 11; rek-sorost@medisin.uio.no), ref: 256722 3. Approved 27/06/2022, Center for Sundhed (De Videnskabsetiske Komiteer Blegdamsvej 60, 1. sal, opgang 94A11 2100 København, Denmark; +45 (0)38666395), ref: H-21069333 4. Approved 16/12/2021, The Ethical Committee of Northern Ostrobothnia (the regional medical research ethics committee of the wellbeing services county of North Ostrobothnia, Kajaanintie 50 (NK-sisäänkäynti), OYS Tutkimuspalveluyksikkö N5 (huone N5 133, 1. krs), 90220 Oulu, Finland; +358 (0)50 448 4955; eettinentoimikunta@pohde.fi), ref: EETTMK 85/2021 266§ |
| Health condition(s) or problem(s) studied | Nasogastric tube decompression after resection for esophageal cancer with gastric conduit reconstruction |
| Intervention | 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: Immediate posatoperative removal of nasogastric tube Control: 5-day use of nasogastric tube (current practice). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/07/2020 |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 450 |
| Total final enrolment | 448 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 21/01/2022 |
| Date of final enrolment | 27/03/2024 |
Locations
Countries of recruitment
- Denmark
- Finland
- Norway
- Sweden
Study participating centres
Uppsala
75185
Sweden
Stockholm
17176
Sweden
Umeå
901 89
Sweden
Örebro
701 85
Sweden
Linköping
581 91
Sweden
Lund
221 85
Sweden
Tromsø
9038
Norway
Trondheim
7006
Norway
Oslo
0424
Norway
Copenhagen
2100
Denmark
Odense
5000
Denmark
Oulu
90220
Finland
Sponsor information
University/education
Department of Surgical Sciences
Uppsala University Hospital
Uppsala
75185
Sweden
| Phone | +46 703785973 |
|---|---|
| per.hellman@surgsci.uu.se | |
| Website | https://www.uu.se/en/ |
"ROR" |
https://ror.org/048a87296 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication of the main findings in high impact peer-reviewed journals. |
| IPD sharing plan | Due to legal restrictions regarding patient data in the participating countries, no raw data can be disseminated in this trial. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.7 | 06/12/2021 | 09/12/2021 | No | No |
| Protocol article | 16/02/2024 | 19/02/2024 | Yes | No | |
| Abstract results | 02/09/2024 | 30/09/2024 | No | No | |
| Protocol file | version 4.0 | 08/01/2025 | 13/01/2025 | No | No |
| Results article | 31/07/2025 | 13/08/2025 | Yes | No |
Additional files
Editorial Notes
13/08/2025: Publication reference added.
14/01/2025: The following changes were made:
1. The recruitment start date was changed from 01/01/2022 to 21/01/2022.
2. The recruitment end date was changed from 31/12/2025 to 27/03/2024.
3. The total final enrolment was changed from 444 to 448.
13/01/2025: Protocol version 4.0 (not peer reviewed) uploaded.
22/10/2024: Ethics approval details added.
01/10/2024: Ethics approval details added.
30/09/2024: Abstract and total final enrolment added.
19/02/2024: Publication reference added.
01/11/2023: The contact confirmed the record is up to date.
09/12/2021: Trial’s existence confirmed by Etikprövningsmyndighetens.
