Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07004634

Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）

This RCT compares three drainage approaches after minimally invasive esophagectomy (chest tube + thoracic mediastinal drainage tube, thoracic, and abdominal mediastinal drainage tube) to evaluate perioperative outcomes, addressing current evidence gaps in pain and complication profiles.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Drainage/Methods Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Dingpei Han, PhD, MD

CONTACT

[email protected]

00862164370045 ext. 666112

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Pathologically confirmed esophageal cancer requiring three-incision esophagectomy (cervical, thoracic, and abdominal incisions)
  • ASA physical status class I-III

Exclusion criteria

  • History of chronic pain or long-term use of analgesics prior to surgery
  • Severe cardiopulmonary dysfunction (e.g., FEV1 <50%)
  • Coagulation disorders or patients undergoing reoperation
  • Intraoperative findings of extensive pleural adhesions, combined resection of adjacent organs, or other conditions deemed by the investigator to warrant exclusion

Treatment and study plan

Chest mediastinal tube

Procedure

Transthoracic mediastinal drainage was performed for postoperative management of the patient.

Abdominal mediastinal tube

Procedure

Transperitoneal mediastinal drainage was performed for postoperative management of the patient.

Chest tube + chest mediastinal tube

Procedure

Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.

Primary outcomes

  1. Postoperative Pain Scores

    Time frame: Pain scores were recorded at different times during the postoperative period when the patients were quiet and active (at 7 AM, 11 AM, 3 PM, and 7 PM) from postoperative day 1 to postoperative day 4.

    Pain scores were assessed based on the visual analog scale according to the World Health Organization guidelines, in which 0 indicated no pain and 10 indicated the worst possible pain.

    We also recorded and evaluated maximum daily pain scores when pain caused by the mediastinal drainage tube incision.

Secondary outcomes

  1. Postoperative complications

    Time frame: Postoperative complications from posoperative day 1 to postoperative month 3

    Postoperative complications included anastomotic leak, major pulmonary complications, and major abdominal complications. Pleural effusion was defined as a drainage volume of greater than 800 mL. Pneumothorax was defined by a distance of greater than 3 cm between the apex of the lung and the top of the ribcage on chest radiography.

Study contacts

Contact information is provided by the study sponsor or research team.

Hecheng Li, PhD, MD

CONTACT

[email protected]

00862164370045 ext. 664566

Wangyang Meng, MD

CONTACT

[email protected]

00861592767592

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Comparison of the Application Effects of Different Drainage Modes in the Perioperative Period of Minimally Invasive Three-Field Radical Esophagectomy for Esophageal Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.