Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy (NCT04663789) | Clinical Trial Compass
UnknownNot Applicable
Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy
China124 participantsStarted 2020-12-01
Plain-language summary
Postoperative fistula is the major complications of distal pancreatectomies which prohibit patients' recovery. Previous studies have reported controversial results regarding the efficacy of pancreatic stump reinforcement methods. Prior research has commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult. Data has shown that staple line plus reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Thus, the investigators design the present study to the question that whether routine staple line plus reinforcement would bring benefit for participants.
Who can participate
Age range
18 Years – 80 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:
* Those who will receive distal pancreatectomy via minimally invasive approaches, no matter benign or malignant;
* Aged from 18 - 80 years;
* Preoperative diagnosis of serous or mucinous cystic adenoma;
* Preoperative diagnosis of solid pseudopapillary tumor (SPT);
* Preoperative diagnosis of neuroendocrine tumor;
* Preoperative diagnosis of intraductal papillary mucinous neoplasm (IPMN);
* Preoperative diagnosis of or pseudocyst;
* Preoperative diagnosis of distal pancreatic malignancies;
* Patients willing to provide informed consent.
Exclusion Criteria:
* History of upper abdominal surgical history such as splenectomy, gastrectomy, liver resection, duodenal or pancreatic resection (not including laparoscopic cystectomy);
* Pancreatic trauma;
* With pneumoperitoneum contraindications;
* With severe heart or pulmonary diseases which is not fit for surgeries.
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.