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Analysis of comfort and safety with versus without nasogastric tube following endoscopic resection of early esophageal cancers and precancerous lesions

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10733506
Enrollment
204
Registered
2025-09-11
Start date
2025-09-09
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Postoperative management following endoscopic resection of early esophageal cancers and precancerous lesions. Cancer

Interventions

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

Sponsors

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

China

Contacts

Public ContactQingmiao Zhao
zqmncc@163.com+86 18653424235

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026