Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparosco… (NCT07087392) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy
China20 participantsStarted 2025-07-20
Plain-language summary
The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are:
1. Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate)
2. What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y?
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 75 years old, gender not limited;
. Patients diagnosed with benign or low-grade malignant tumors in the head or middle section of the pancreas by CT or MRI;
. ECOG score 0-1.
Exclusion criteria
. Those with severe heart, liver or kidney insufficiency, or those who are assessed as intolerant to surgery or anesthesia, or those with ASA grade \> 3;
. Patients with a history of or concurrent other malignant tumors, or other serious infections or infectious diseases, or those who are unable to complete the anastomosis surgery;
. Uncontrollable concomitant diseases, including but not limited to severe coronary artery disease, COPD or asthma, uncontrollable cerebrovascular diseases, symptomatic congestive failure, unstable angina pectoris, arrhythmia, or other diseases that the researchers consider ineligible for enrollment;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and assessment of the surgical process
Timeframe: During operation
2
Operative time
Timeframe: During operation
3
Intraoperative blood loss
Timeframe: During operation
4
Postoperative complications
Timeframe: From the date of surgery (Day 0) up to 90 days postoperatively