NCT07532759Not yet recruiting
Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice
Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice: An Exploratory Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
Pancreaticoduodenectomy (PD) is a complex surgical procedure commonly performed for tumors of the pancreatic head and periampullary region. Many patients present with obstructive jaundice and undergo preoperative percutaneous transhepatic cholangial drainage (PTCD) to relieve biliary obstruction. However, there is currently no consensus on whether the PTCD catheter should be removed or retained during surgery. This multicenter, prospective randomized controlled trial aims to compare two intraoperative strategies: removal versus retention of the PTCD catheter during PD. Participants will be randomly assigned to either group. The study will evaluate whether these different approaches influence postoperative outcomes, particularly major complications such as bile leak and severe postoperative morbidity within 90 days after surgery. In addition to complications, the study will assess recovery after surgery, including return of gastrointestinal function, length of hospital stay, and quality of recovery, as well as laboratory indicators of liver function and inflammation. The results of this study are expected to provide evidence to guide surgical decision-making regarding PTCD management during PD and to improve patient outcomes.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 26 Mar 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- Xu'an Wang
- Diseases
- Pancreatic cancer
- NCT number
- NCT07532759
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Aug 2026 to the primary completion date, 28 Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of major surgery within 4 weeks prior to enrollment
Other illness
- Presence of distant metastasis or locally unresectable disease
- Severe cardiac, renal, or pulmonary dysfunction that contraindicates surgery
- Uncontrolled infection
Other
- Pregnancy or breastfeeding
- Poor compliance or inability to complete follow-up
Who the study is looking for
- Age 18 to 85 years
- Patients with pancreatic head or periampullary tumors scheduled for pancreaticoduodenectomy
- Presence of obstructive jaundice and completion of preoperative
- percutaneous transhepatic cholangial drainage (PTCD)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Able to understand the study and provide written informed consent
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.