An interventional study of PTCD Catheter Removal and PTCD Catheter Retention in Obstructive Jaundice, Pancreatic Head Cancer and Periampullary Neoplasms, sponsored by Xu'an Wang. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Xu'an Wang · Not applicable, Interventional, and Treatment
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.
This multicenter, prospective, randomized controlled trial is designed to evaluate the impact of intraoperative management of preoperative percutaneous transhepatic cholangial drainage (PTCD) catheters on postoperative outcomes in patients undergoing pancreaticoduodenectomy (PD).
Participants meeting eligibility criteria will be randomly assigned in a 1:1 ratio to either intraoperative PTCD catheter removal or retention using a centralized randomization system with stratification by study center and a concealed block design. The study follows a parallel-group design without crossover.
Perioperative management, including surgical technique, postoperative care, and complication management, will be standardized across participating centers according to predefined protocols to minimize inter-center variability. Outcome assessment will be conducted by independent evaluators blinded to treatment allocation. Data will be collected prospectively using an electronic data capture (EDC) system with built-in validation rules, audit trails, and centralized monitoring to ensure data quality and integrity.
The primary analysis will focus on estimating the effect size and corresponding confidence intervals for the predefined outcomes, rather than formal hypothesis testing, given the exploratory nature of the study. Multicenter effects will be accounted for in the analysis by incorporating study center as a stratification factor or covariate.
Participants will be followed for 90 days after surgery, during which predefined clinical outcomes and safety data will be systematically recorded. The findings of this study are intended to generate high-quality preliminary evidence to inform optimal intraoperative PTCD management strategies and support the design of future confirmatory trials.
62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →This is the only study on the registry with Xu'an Wang as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will undergo intraoperative removal of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be removed after completion of the biliary-enteric anastomosis, followed by routine closure of the hepatic duct puncture site. No external biliary drainage will be maintained postoperatively, and only standard abdominal drainage will be placed.
Procedure: PTCD Catheter Removal
Participants assigned to this arm will undergo intraoperative retention of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be maintained as a stent for the biliary-enteric anastomosis and used for postoperative external drainage. Planned catheter removal will be performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography.
Procedure: PTCD Catheter Retention
The preoperative percutaneous transhepatic cholangial drainage (PTCD) catheter is removed intraoperatively during pancreaticoduodenectomy. Removal is performed after completion of the biliary-enteric anastomosis, followed by closure of the hepatic duct puncture site. No external biliary drainage is maintained postoperatively, and only standard abdominal drainage is used.
The preoperative percutaneous transhepatic cholangial drainage (PTCD) catheter is retained intraoperatively during pancreaticoduodenectomy. The catheter is used as a stent to support the biliary-enteric anastomosis and is maintained for postoperative external biliary drainage. Planned removal is performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography.
Composite rate of major postoperative complications
Incidence of a composite endpoint defined as B/C-grade bile leak according to the International Study Group of Liver Surgery (ISGLS) criteria or Clavien-Dindo grade ≥ III complications occurring after pancreaticoduodenectomy.
Time frame: Up to 90 days
B/C-grade bile leak
Incidence of B/C-grade bile leak defined according to ISGLS criteria.
Time frame: Up to 90 days
B/C-grade pancreatic fistula
Incidence of clinically relevant postoperative pancreatic fistula (grade B/C) defined by ISGPS criteria.
Time frame: Up to 90 days
Postoperative infections
Incidence of postoperative infections, including intra-abdominal infection, biliary infection, pulmonary infection, and wound infection.
Time frame: Up to 90 days
Time to gastrointestinal recovery
Time to first flatus and time to first oral intake after surgery.
Time frame: Up to 30 days
Length of hospital stay
Total duration of hospitalization after surgery.
Time frame: Perioperative
Time to initiation of adjuvant therapy
Time from surgery to initiation of postoperative adjuvant therapy.
Time frame: Up to 90 days
90-day readmission rate
Proportion of patients readmitted within 90 days after surgery.
Time frame: Up to 90 days
90-day mortality
All-cause mortality within 90 days after surgery.
Time frame: Up to 90 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Feb 2028, 18 months later.
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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