Analysis of comfort and safety with versus without nasogastric tube following endoscopic resection of early esophageal cancers and precancerous lesions
| ISRCTN | ISRCTN10733506 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10733506 |
| Secondary identifying numbers | CAMS Innovation Fund for Medical Sciences (CIFMS) grant numbers 2021-I2M-1-061, 2021-I2M-1-015, 2021-I2M-1-013; National High Level Hospital Clinical Research Funding and National Cancer Center Climbing Fund grant number NCC202418005 |
- Submission date
- 09/09/2025
- Registration date
- 11/09/2025
- Last edited
- 11/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Endoscopic resection (ER) is a common treatment for early esophageal cancer and precancerous lesions. However, whether placing a nasogastric tube (NGT) after ER is beneficial remains unclear. This study aims to compare the safety and comfort of patients with versus without NGT placement after ER.
Who can participate?
Adults with early esophageal cancer or precancerous lesions confirmed by pathology, suitable for endoscopic treatment, without esophageal stricture, and with lesions involving ≤75% of the esophageal circumference.
What does the study involve?
Participants will be randomly assigned to either have a nasogastric tube placed for 48 hours after ER or not have one placed. Comfort and safety outcomes will be assessed through questionnaires and clinical evaluations.
What are the possible benefits and risks of participating?
Benefits may include improved comfort and shorter hospital stays. Risks are minimal but may include discomfort from the tube or routine procedural complications.
Where is the study run from?
The study is conducted at multiple centers in China, led by the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences.
When is the study starting and how long is it expected to run for?
October 2024 to October 2025. The study enrolment starts in September 2025 and is expected to run for one month.
Who is funding the study?
1. Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Science (CIFMS)
2. National High-Level Hospital Clinical Research Fund and National Cancer Center Climbing Fund
Who is the main contact?
Qingmiao Zhao, zqmncc@163.com
Contact information
Public, Scientific
Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
100021
China
| Phone | +86 18653424235 |
|---|---|
| zqmncc@163.com |
Principal Investigator
Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
100021
China
| Phone | +86 18653424235 |
|---|---|
| zqmnwu@163.com |
Study information
| Study design | Multicenter interventional randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Analysis of comfort and safety with versus without nasogastric tube following endoscopic resection of early esophageal cancers and precancerous lesions: a prospective, multicenter, randomized controlled study |
| Study objectives | The principal objectives of this study were to evaluate the necessity of nasogastric tube (NGT) placement following esophageal endoscopic resection (ER). The primary hypothesis was that withholding NGT placement would not increase the rate of secondary endoscopic intervention due to delayed bleeding, demonstrating non-inferiority in safety compared to routine NGT use. Furthermore, the study hypothesized that avoiding NGT placement would significantly improve patient comfort by reducing procedure-related discomfort and pain, and would avoid the unnecessary consumption of medical and nursing resources, thereby aligning with the principles of enhanced recovery after surgery (ERAS). |
| Ethics approval(s) |
Approved 14/11/2024, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National GCP Center for Anticancer Drugs, The Independent Ethics Committee (17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China; +8610-87788495; cancergcp@163.com), ref: 24/547-4827 |
| Health condition(s) or problem(s) studied | Postoperative management following endoscopic resection of early esophageal cancers and precancerous lesions. |
| Intervention | This is a prospective, multicenter, randomized controlled trial. A total of 208 patients undergoing endoscopic resection for early esophageal cancer or precancerous lesions were randomly assigned (1:1) via a centralized system using R software to either the NO-NGTB group (no nasogastric tube placement) or the NGTB group (nasogastric tube placement with external negative pressure suction and drainage monitoring). The tube in the NGTB group was removed 48 hours postoperatively. The primary outcomes are the rate of secondary endoscopic intervention due to delayed bleeding and patient comfort scores (GCQ, subjective discomfort symptoms, VAS pain scores). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. The rate of secondary endoscopic intervention due to delayed bleeding (manifested as hematemesis/melena/hematochezia) measured using clinical observation and endoscopic examination within 30 days postoperatively 2. Patient comfort level measured using the Global Comfort Questionnaire (GCQ) and a Subjective Discomfort Symptom (SDS) record form at the time of surgery, 24 hours postoperatively, and 48 hours postoperatively 3. Throat and nasal pain measured using Visual Analogue Scale (VAS) pain scores when patients reported experiencing pain at the time of surgery, 24 hours postoperatively, or 48 hours postoperatively |
| Secondary outcome measures | The rate of postoperative pneumonia, delayed postoperative perforation, reinsertion rate of nasogastric tubes in the NO-NGTB group, and spontaneous tube removal rate in the NGTB group were measured using clinical observation and endoscopic examination within 30 days postoperatively. |
| Overall study start date | 23/10/2024 |
| Completion date | 20/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 204 |
| Key inclusion criteria | 1. All cases diagnosed preoperatively via electronic magnification chromoendoscopy and biopsy as early esophageal squamous cell carcinoma or precancerous lesions, with enhanced CT excluding lymph node or distant metastasis 2. No prior esophageal stricture, with preoperative assessment showing lesion circumference ≤ 75% of esophageal circumference 3. Postoperative pathology confirming early-stage esophageal squamous cell carcinoma or precancerous lesions 4. Eligibility for endoscopic treatment |
| Key exclusion criteria | 1. Successful ER, but intraoperative perforation occurred 2. Subjects currently receiving anticoagulant therapy (e.g., ongoing or recent use of warfarin, clopidogrel, heparin, aspirin, or other anticoagulants) |
| Date of first enrolment | 09/09/2025 |
| Date of final enrolment | 09/10/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Beijing
100021
China
Linzhou, Henan
456550
China
Feicheng
271600
China
Cixian
056500
China
Hebei
05000
China
Sponsor information
Hospital/treatment centre
Department of Endoscopy
Beijing
100021
China
Funders
Funder type
Research organisation
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
11/09/2025: Study's existence confirmed by the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National GCP Center for Anticancer Drugs, The Independent Ethics Committee, China.
