Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）

NCT07004634 | Recruiting DMC

• 1 other identifier: RTS-026
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer; Drainage/Methods; Postoperative Pain

Keywords

Esophageal cancer; Mediastinal drainage tube; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores

  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.

  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.

Secondary Outcomes (1)

• Postoperative complications

  Postoperative complications from posoperative day 1 to postoperative month 3

Study Arms (3)

Abdominal mediastinal tube

EXPERIMENTAL

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

Procedure: Abdominal mediastinal tube

Chest mediastinal tube

EXPERIMENTAL

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

Procedure: Chest mediastinal tube

Chest tube + chest mediastinal tube

EXPERIMENTAL

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

Procedure: Chest tube + chest mediastinal tube

Interventions

Chest mediastinal tube PROCEDURE

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

Chest mediastinal tube

Abdominal mediastinal tube PROCEDURE

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

Abdominal mediastinal tube

Chest tube + chest mediastinal tube PROCEDURE

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

Chest tube + chest mediastinal tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Pain, Postoperative

Interventions

Chest Tubes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Hecheng Li, PhD, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hecheng Li, PhD, MD

CONTACT

00862164370045; lihecheng2000@hotmail.com

Wangyang Meng, MD

CONTACT

00861592767592; mengwymed@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 4, 2025
• Study Start: April 30, 2025
• Primary Completion: May 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)