Comparing drainage options after minimally invasive esophagectomy
Comparison of the Application Effects of Different Drainage Modes in the Perioperative Period of Minimally Invasive Three-Field Radical Esophagectomy for Esophageal Cancer
This trial tests three different drainage approaches after minimally invasive esophagectomy to see which leads to less postoperative pain and fewer complications for adults with esophageal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07004634 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares three postoperative drainage strategies following three‑incision minimally invasive esophagectomy: a chest mediastinal tube, an abdominal mediastinal tube, and a combination of chest tube plus chest mediastinal tube. Adult patients (age ≥18) with pathologically confirmed esophageal cancer and ASA class I–III who are undergoing the specified procedure are eligible, while those with chronic pain, severe cardiopulmonary dysfunction, coagulation disorders, reoperation, or extensive intraoperative adhesions are excluded. The trial measures perioperative outcomes with emphasis on postoperative pain and complication profiles to address current evidence gaps. All procedures and follow-up occur at a single center (Ruijin Hospital, Shanghai).
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed esophageal cancer scheduled for three‑incision minimally invasive esophagectomy who are ASA class I–III and do not have chronic preoperative pain or major cardiopulmonary or coagulation contraindications are ideal candidates.
Not a fit: Patients with chronic pain or long‑term analgesic use, severe cardiopulmonary dysfunction (e.g., FEV1 <50%), coagulation disorders, need for reoperation, extensive pleural adhesions, or combined organ resections are excluded and therefore unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could identify a drainage approach that reduces postoperative pain and complications and guide standard practice after minimally invasive esophagectomy.
How similar studies have performed: Previous studies of mediastinal versus pleural drainage after esophagectomy have shown mixed results, and direct randomized comparisons of these three specific drainage strategies are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Hecheng Li, PhD, MD — Ruijin Hospital
- Study coordinator: Hecheng Li, PhD, MD
- Email: lihecheng2000@hotmail.com
- Phone: 00862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.